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Category: Medicine

Altuviiio Shows Sustained Protection Against Bleeding Episodes in Children with Severe Hemophilia A
Medicine

Altuviiio Shows Sustained Protection Against Bleeding Episodes in Children with Severe Hemophilia A

adminJuly 21, 2024

Image credit: Svetlana | stock.adobe.com Results from the Phase III XTEND-Kids trial (NCT04759131) found that once-weekly Altuviiio (efanesoctocog alfa) produced…

Digital Technology’s Impact on Rett Syndrome Management
Medicine

Digital Technology’s Impact on Rett Syndrome Management

adminJuly 20, 2024

Image Credit: © Blue Planet Studio – stock.adobe.com Rett syndrome, a rare genetic neurological and developmental disorder that primarily affects…

Results From Phase III SPACE Trial of AJOVY Show Promise in Episodic Migraine Prevention
Medicine

Results From Phase III SPACE Trial of AJOVY Show Promise in Episodic Migraine Prevention

adminJuly 20, 2024July 20, 2024

Image Credit: © yodiyim – stock.adobe.com Teva Pharmaceuticals has shared new results from the Phase III SPACE clinical trial (NCT03539393)…

Paxlovid Postexposure Prophylaxis Not Found to Significantly Lower Risk of Symptomatic SARS-CoV-2
Medicine

Paxlovid Postexposure Prophylaxis Not Found to Significantly Lower Risk of Symptomatic SARS-CoV-2

adminJuly 19, 2024

Image credit: JeromeCronenberger | stock.adobe.com Findings from a Phase II/III study show postexposure prophylaxis with Paxlovid (nirmatrelvir–ritonavir; Pfizer) for five…

NUBEQA Meets Primary Endpoint for Phase III ARANOTE Trial in Men with Prostate Cancer
Medicine

NUBEQA Meets Primary Endpoint for Phase III ARANOTE Trial in Men with Prostate Cancer

adminJuly 19, 2024

Image Credit: © Dr_Microbe – stock.adobe.com The Phase III ARANOTE trial (NCT04736199) of Bayer’s NUBEQA (darolutamide) plus androgen deprivation therapy…

Phase III Data for Susvimo Show Promise in the Treatment of Two Diabetic Eye Conditions
Medicine

Phase III Data for Susvimo Show Promise in the Treatment of Two Diabetic Eye Conditions

adminJuly 18, 2024

Image Credit: © Pixel-Shot – stock.adobe.com Emerging two-year data from a pair of Phase III studies—Pagoda (NCT04108156) and Pavilion (NCT04503551)—evaluating…

Overcoming Challenges with Critical Care Trials During COVID-19
Medicine

Overcoming Challenges with Critical Care Trials During COVID-19

adminJuly 18, 2024

Image Credit: © NicoElNino – stock.adobe.com There is no doubting the impact of the COVID-19 pandemic on clinical research. According…

Phase III Trial Shows Older Patients with Atrial Fibrillation May Benefit From Lower-Dose Anticoagulants
Medicine

Phase III Trial Shows Older Patients with Atrial Fibrillation May Benefit From Lower-Dose Anticoagulants

adminJuly 17, 2024July 17, 2024

Image credit: magicmine | stock.adobe.com Patients aged 80 years and above with atrial fibrillation (AF) may gain a benefit from…

Q&A with Tom deLaubenfels, PhD, Director of Data Science, Strados Labs
Medicine

Q&A with Tom deLaubenfels, PhD, Director of Data Science, Strados Labs

adminJuly 17, 2024

Tom deLaubenfels, PhD, Director of Data Science, Strados Labs In respiratory clinical trials, cough frequency monitoring can serve as a…

Trial Favors Reteplase Over Alteplase in Improving Functional Outcomes in Patients with Ischemic Stroke
Medicine

Trial Favors Reteplase Over Alteplase in Improving Functional Outcomes in Patients with Ischemic Stroke

adminJuly 16, 2024

Image credit: vukkostic | stock.adobe.com Data from the Phase III RAISE trial (NCT05295173) show treatment with reteplase has a greater…

FDA Clears IND for Selective Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Phase I Study to Commence
Medicine

FDA Clears IND for Selective Fatty Acid Binding Protein 5 Inhibitor, ART26.12, Phase I Study to Commence

adminJuly 16, 2024July 16, 2024

Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared Artelo Biosciences’ Investigational New Drug application (IND) for ART26.12,…

Novel Anti-CD38 Targeted Therapy Shows Promise Treating Immune Thrombocytopenia in Phase II Trial
Medicine

Novel Anti-CD38 Targeted Therapy Shows Promise Treating Immune Thrombocytopenia in Phase II Trial

adminJuly 15, 2024

Image credit: Andrew Dorey | stock.adobe.com Findings from the Phase I-II 2022-CM313-ITP trial (NCT05694767) show that an investigational anti-CD38 targeted…

Positive Interim Phase II Data Show Strong Overall Response and Disease Control Rates for MAT2A Inhibitor, IDE397
Medicine

Positive Interim Phase II Data Show Strong Overall Response and Disease Control Rates for MAT2A Inhibitor, IDE397

adminJuly 15, 2024

Image Credit: © iDoPixBox – stock.adobe.com IDEAYA Biosciences has shared positive clinical data for the IDE397 Phase II monotherapy expansion…

Prelude Therapeutics Collaborates With Merck to Evaluate PRT3789 in Combination With KEYTRUDA
Medicine

Prelude Therapeutics Collaborates With Merck to Evaluate PRT3789 in Combination With KEYTRUDA

adminJuly 14, 2024

Image Credit: © peterschreiber.media – stock.adobe.com Prelude Therapeutics has announced a new clinical trial collaboration and supply agreement with Merck…

Patient-centric Approaches in Designing and Creating Products
Medicine

Patient-centric Approaches in Designing and Creating Products

adminJuly 14, 2024July 14, 2024

ACT: How can sponsors embed patient and caregiver insights into product vision and design? Birchard: I’m currently a product owner,…

Acclinate CEO Del Smith Discusses FDA’s Recently Released Diversity Action Plan Guidance
Medicine

Acclinate CEO Del Smith Discusses FDA’s Recently Released Diversity Action Plan Guidance

adminJuly 13, 2024July 13, 2024

ACT: What are your initial thoughts on FDA releasing the Diversity Action Plan guidance? Smith: My initial thoughts on the…

FDA Grants Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma
Medicine

FDA Grants Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma

adminJuly 13, 2024July 13, 2024

Image Credit: © Christoph Burgstedt – stock.adobe.com The FDA has granted Fast Track Designation to Obsidian Therapeutics’ OBX-115, a novel…

Brigatinib Shows Clinical Benefit Across Multiple Tumor Types in Patients with NF2-Related Schwannomatosis with Progressive Tumors
Medicine

Brigatinib Shows Clinical Benefit Across Multiple Tumor Types in Patients with NF2-Related Schwannomatosis with Progressive Tumors

adminJuly 12, 2024

Image credit: kh_art | stock.adobe.com Results from the Phase II INTUITT-NF2 trial (NCT04374305) show brigatinib produced radiographic responses across multiple…

Pfizer Selects Once-daily Modified-release Formulation for Danuglipron Following Analysis of Ongoing Clinical Trial
Medicine

Pfizer Selects Once-daily Modified-release Formulation for Danuglipron Following Analysis of Ongoing Clinical Trial

adminJuly 12, 2024

Image Credit: © VadimGuzhva – stock.adobe.com Pfizer announced it has selected its preferred once-daily modified release formulation for danuglipron, an…

Real–World Data Show Efficacy of Beyfortus Against Hospitalization for RSV-Associated Bronchiolitis
Medicine

Real–World Data Show Efficacy of Beyfortus Against Hospitalization for RSV-Associated Bronchiolitis

adminJuly 11, 2024

Image credit: PH alex aviles | stock.adobe.com An observational study (NCT06030505) in a real-world setting found that Beyfortus (nirsevimab) lowers the…

Leveraging eCOA Technologies to Create Greater Patient Centricity
Medicine

Leveraging eCOA Technologies to Create Greater Patient Centricity

adminJuly 11, 2024

ACT: How can sponsors leverage electronic clinical outcome assessment (eCOA) technologies to facilitate the collection and management of patient-reported outcomes…

Tivdak Shows Significantly Greater Efficacy vs. Chemotherapy in Second-, Third-Line Treatment of Recurrent Cervical Cancer
Medicine

Tivdak Shows Significantly Greater Efficacy vs. Chemotherapy in Second-, Third-Line Treatment of Recurrent Cervical Cancer

adminJuly 10, 2024

Image credit: Crystal light | stock.adobe.com Data from the Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628) show second- or third-line treatment…

Strategies to Bridge Gaps Between Study Participants and Industry
Medicine

Strategies to Bridge Gaps Between Study Participants and Industry

adminJuly 10, 2024

ACT: What strategies can sponsors employ to bridge the gaps between study participants and the industry, ensuring open and continuous…

Dupixent Associated With Reduced Exacerbations, Improved Lung Function in Patients with COPD
Medicine

Dupixent Associated With Reduced Exacerbations, Improved Lung Function in Patients with COPD

adminJuly 9, 2024

Image credit: peterschreiber.media | stock.adobe.com Results from the Phase III NOTUS trial (NCT04456673) demonstrated that Dupixent (dupilumab; Sanofi and Regeneron)…

Incorporating Patient and Caregiver Perspectives
Medicine

Incorporating Patient and Caregiver Perspectives

adminJuly 9, 2024

ACT: Why should sponsors prioritize incorporating patient and caregiver perspectives into clinical trial design and conduct? Birchard: I love this…

Donidalorsen Shows Promise as Prophylactic Treatment for Hereditary Angioedema
Medicine

Donidalorsen Shows Promise as Prophylactic Treatment for Hereditary Angioedema

adminJuly 8, 2024

Image credit: ZayNyi | stock.adobe.com The results of the Phase III OASIS-HAE (NCT05139810) clinical trial and OASISplus open-label extension (OLE) trial…

The Role of Artificial Intelligence in Medical Review
Medicine

The Role of Artificial Intelligence in Medical Review

adminJuly 8, 2024

June 27th 2024 Article AI can be applied to patient data in real time, allowing medical reviewer teams to actively…

Future Use of Artificial Intelligence in Clinical Trials
Medicine

Future Use of Artificial Intelligence in Clinical Trials

adminJuly 7, 2024July 7, 2024

ACT: Looking forward, where do you see the use of artificial intelligence (AI) in clinical trials in five years? Lacroix:…

New Phase II Data Shows Frexalimab Reduced Nerve Cell Damage in Relapsing Multiple Sclerosis
Medicine

New Phase II Data Shows Frexalimab Reduced Nerve Cell Damage in Relapsing Multiple Sclerosis

adminJuly 7, 2024

Image Credit: © Aerial Mike – stock.adobe.com Emerging data released from Sanofi show its CD40L monoclonal antibody, frexalimab, reduced a…

Industry Leaders React to FDA’s Newly Announced Diversity Action Plan Guidance
Medicine

Industry Leaders React to FDA’s Newly Announced Diversity Action Plan Guidance

adminJuly 6, 2024

Tenaerts: It was awaited, so we’re all happy it came out and I think it’s going in the right direction.…

Hepatitis Delta Treatment Combination Receives FDA IND Clearance and Fast Track Designation Following Positive Phase II Results
Medicine

Hepatitis Delta Treatment Combination Receives FDA IND Clearance and Fast Track Designation Following Positive Phase II Results

adminJuly 6, 2024

Image Credit: © photon_photo – stock.adobe.com The FDA has cleared Vir Biotechnology’s investigational new drug (IND) application and granted Fast…

FDA Clears Investigational New Drug Application for Potential Leukemia Treatment, GTB-3650
Medicine

FDA Clears Investigational New Drug Application for Potential Leukemia Treatment, GTB-3650

adminJuly 5, 2024

Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared GT Biopharma’s Investigational New Drug (IND) application for GTB-3650.…

Industry Leaders Discuss the Impact of FDA’s Diversity Action Plan
Medicine

Industry Leaders Discuss the Impact of FDA’s Diversity Action Plan

adminJuly 5, 2024

Tenaerts: I think it’ll help the industry get more data, actionable data on a diverse population—there’s different ways to do…

Q&A with Nick Slack, Chairman and CEO of START Center for Cancer Research
Medicine

Q&A with Nick Slack, Chairman and CEO of START Center for Cancer Research

adminJuly 4, 2024

Nick Slack, Chairman and CEO, START Center for Cancer Research Clinical trials can offer patients who have run out of…

Boehringer Ingelheim, Gubra Initiate Phase I Clinical Trial for BI 3034701, a Potential Obesity Treatment
Medicine

Boehringer Ingelheim, Gubra Initiate Phase I Clinical Trial for BI 3034701, a Potential Obesity Treatment

adminJuly 4, 2024

Image Credit: Adobe Stock Images/Hunterframe Boehringer Ingelheim and Gubra have launched a Phase I clinical trial for BI 3034701, a…

Emerging Data From Phase I Clinical Study for Pancreatic Cancer Show Stable Disease Activity
Medicine

Emerging Data From Phase I Clinical Study for Pancreatic Cancer Show Stable Disease Activity

adminJuly 3, 2024

Image Credit: © Matthieu – stock.adobe.com Sirnaomics has announced its small interfering RNA (siRNA) drug candidate, STP707, showed a strong…

National Institutes of Health Initiates Phase I Trial to Test the Safety of an Experimental Nasal COVID-19 Vaccine
Medicine

National Institutes of Health Initiates Phase I Trial to Test the Safety of an Experimental Nasal COVID-19 Vaccine

adminJuly 3, 2024

Image Credit: Adobe Stock Images/fotoyou The National Institutes of Health (NIH) has begun a Phase I clinical trial to test…

Navigating the Complexities of Patient Screening: Streamlining the Process for Accelerated Clinical Trials
Medicine

Navigating the Complexities of Patient Screening: Streamlining the Process for Accelerated Clinical Trials

adminJuly 2, 2024

Discover how streamlining patient screening can help accelerate clinical trials. Simplifying and improving the patient journey and optimized screening processes…

Phase III Vivacity-MG3 Trial Demonstrates Superiority of Nipocalimab Over Placebo in Treating Patients with Generalized Myasthenia Gravis
Medicine

Phase III Vivacity-MG3 Trial Demonstrates Superiority of Nipocalimab Over Placebo in Treating Patients with Generalized Myasthenia Gravis

adminJuly 2, 2024

Image Credit: Adobe Stock Images/Lila Patel Results from the Phase III Vivacity-MG3 trial show that Johnson & Johnson’s (J&J) nipocalimab…

Advancing Medical reviews with AI
Medicine

Advancing Medical reviews with AI

adminJuly 1, 2024

AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient safety, with…

OpenBioLLM
Medicine

OpenBioLLM

adminJuly 1, 2024

Introducing OpenBioLLM-Llama3-70B & 8B: Saama’s AI Research Lab Released the Most Openly Available Medical-Domain LLMs to Date

Pediatric Patients with Eosinophilic Esophagitis Administered Dupixent Achieve Significant Improvements Across Multiple Disease Measures
Medicine

Pediatric Patients with Eosinophilic Esophagitis Administered Dupixent Achieve Significant Improvements Across Multiple Disease Measures

adminJune 30, 2024

Image credit: shidlovski | stock.adobe.com Phase III trial data published by The New England Journal of Medicine (NEJM) show the efficacy…

Rybrevant with Leclaza Shows Significantly Improved Progression-Free Survival vs. Tagrisso Treating EGFR-Mutated Advanced NSCLC
Medicine

Rybrevant with Leclaza Shows Significantly Improved Progression-Free Survival vs. Tagrisso Treating EGFR-Mutated Advanced NSCLC

adminJune 30, 2024

Image credit: Sebastian Kaulitzki | stock.adobe.com The combination of Rybrevant (amivantamab-vmjw; Janssen Pharmaceutical) with Leclaza (lazertinib; Johnson & Johnson) produced…

Expanding Conceptual Model of Disease into Conceptual Model of Patient Experience for Designing, Interpreting Medication Effects
Medicine

Expanding Conceptual Model of Disease into Conceptual Model of Patient Experience for Designing, Interpreting Medication Effects

adminJune 29, 2024

Image credit: Deemerwha studio | stock.adobe.com Patient experience data (PED) are no longer a nice to have; it is emerging…

Considerations for Integrating Artificial Intelligence
Medicine

Considerations for Integrating Artificial Intelligence

adminJune 29, 2024

ACT: What should industry stakeholders be keeping top of mind when implementing artificial intelligence (AI) into their workflows? Lacroix: When…

Benefits of Using AI in Data Management
Medicine

Benefits of Using AI in Data Management

adminJune 28, 2024

ACT: What are the greatest benefits to utilizing artificial intelligence (AI) in data management? Lacroix: Coming from a data management…

New Results From National Comprehensive Cancer Network Survey Show Drug Shortages are Impacting Clinical Trials
Medicine

New Results From National Comprehensive Cancer Network Survey Show Drug Shortages are Impacting Clinical Trials

adminJune 28, 2024

Image Credit: © Andrii Yalanskyi – stock.adobe.com The National Comprehensive Cancer Network (NCCN) has published new results for its latest…

Addressing Data Management Challenges With Automation
Medicine

Addressing Data Management Challenges With Automation

adminJune 27, 2024

ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial intelligence (AI)?…

FDA Issues Draft Guidance on the Submission of Diversity Action Plans
Medicine

FDA Issues Draft Guidance on the Submission of Diversity Action Plans

adminJune 27, 2024

Image Credit: © Jakub Krechowicz – stock.adobe.com The FDA has issued a draft guidance which provides details to medical product…

Complexities in Data Management
Medicine

Complexities in Data Management

adminJune 26, 2024

ACT: What are some of the biggest challenges you are currently seeing with data management in clinical trials? Lacroix: Since…

FDA Clears Adicet Bio’s IND Application for ADI-270 in Renal Cell Carcinoma, Phase I Study to Begin in 2024
Medicine

FDA Clears Adicet Bio’s IND Application for ADI-270 in Renal Cell Carcinoma, Phase I Study to Begin in 2024

adminJune 26, 2024

Image Credit: © Crystal light – stock.adobe.com Adicet Bio has announced that the FDA has cleared its Investigational New Drug…

Results from Phase III Trials Show Eli Lilly’s Tirzepatide Reduces Obstructive Sleep Apnea Severity
Medicine

Results from Phase III Trials Show Eli Lilly’s Tirzepatide Reduces Obstructive Sleep Apnea Severity

adminJune 25, 2024

Image Credit: © terovesalainen – stock.adobe.com Eli Lilly has announced results from its Phase III clinical trials of tirzepatide for…

Usage of Patient-Reported Outcomes in Blood Cancer Clinical Trials
Medicine

Usage of Patient-Reported Outcomes in Blood Cancer Clinical Trials

adminJune 25, 2024

Image Credit: © putilov_denis – stock.adobe.com In recent years, there has been a growing interest in the use of patient-reported…

Accelerating the Use of RWD for Oncology Clinical Trial Planning
Medicine

Accelerating the Use of RWD for Oncology Clinical Trial Planning

adminJune 24, 2024

As medical facilities become more equipped to handle different telemedicine platforms and procedures, more clinical trials are back up and…

Emerging Biosimilars and the Importance of Identifying Experienced Providers
Medicine

Emerging Biosimilars and the Importance of Identifying Experienced Providers

adminJune 24, 2024

Although biologics and biosimilar drugs only represent 2% of U.S. prescription volume, these naturally sourced medications have recently become the…

DIA 2024: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology
Medicine

DIA 2024: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology

adminJune 23, 2024

Image Credit: Andy Studna In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles,…

Phase III GRAVITI Trial Data Power sBLA Submission for Tremfya to Treat Crohn Disease
Medicine

Phase III GRAVITI Trial Data Power sBLA Submission for Tremfya to Treat Crohn Disease

adminJune 23, 2024

Image credit: Matthieu | stock.adobe.com Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for…

Accelerating Clinical Trial Activation
Medicine

Accelerating Clinical Trial Activation

adminJune 22, 2024

Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG. Site activation of new clinical…

Ginny Beakes-Read of Johnson & Johnson Discusses Regulatory Challenges
Medicine

Ginny Beakes-Read of Johnson & Johnson Discusses Regulatory Challenges

adminJune 22, 2024

ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should be keeping…

Pivoting Toward Sustainable Supply Chains in Clinical Research
Medicine

Pivoting Toward Sustainable Supply Chains in Clinical Research

adminJune 21, 2024

Image credit: Corona Borealis | stock.adobe.com The clinical research industry has historically operated with a focus on effectively and efficiently…

Allison Cuff Shimooka of TransCelerate Biopharma Discusses Innovation in Clinical Research
Medicine

Allison Cuff Shimooka of TransCelerate Biopharma Discusses Innovation in Clinical Research

adminJune 21, 2024

ACT: How is FDA promoting innovation in clinical trial design and conduct? Cuff Shimooka: It’s a timely question, having just…

AstraZeneca’s Truqap Fails to Meet Primary Endpoints in Phase III Trial for Locally Advanced or Metastatic Triple-Negative Breast Cancer
Medicine

AstraZeneca’s Truqap Fails to Meet Primary Endpoints in Phase III Trial for Locally Advanced or Metastatic Triple-Negative Breast Cancer

adminJune 20, 2024

Image Credit: Adobe Stock Images/Sebastian Kaulitzki Results from the Phase III CAPItello-290 trial evaluating AstraZeneca’s Truqap (capivasertib) in combination with…

Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research
Medicine

Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research

adminJune 20, 2024

ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical research? DiCicco:…

Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM
Medicine

Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM

adminJune 19, 2024

ACT: What are you looking forward to working on and achieving with FDA under the renewed CRADA agreement? Hughes: We…

Challenges and Opportunities for Industry Sponsors
Medicine

Challenges and Opportunities for Industry Sponsors

adminJune 17, 2024

Image credit: wladimir1804 | stock.adobe.com Introduction The increasing focus on diversity in clinical trials by regulatory authorities worldwide, combined with…

Investigational COVID-19 Vaccine Shows Non-Inferior Efficacy vs. Spikevax in Phase III Trial
Medicine

Investigational COVID-19 Vaccine Shows Non-Inferior Efficacy vs. Spikevax in Phase III Trial

adminJune 17, 2024

Image credit: rost9 | stock.adobe.com Findings from the Phase III NextCOVE (NCT05815498) trial of Moderna’s mRNA-1283 showed the next-generation, investigational…

FDA Grants Accelerated Approval to Bristol Myers Squibb’s Augtyro for the Treatment of NTRK-Positive Locally Advanced or Metastatic Solid Tumors
Medicine

FDA Grants Accelerated Approval to Bristol Myers Squibb’s Augtyro for the Treatment of NTRK-Positive Locally Advanced or Metastatic Solid Tumors

adminJune 16, 2024June 16, 2024

Image Credit: Adobe Stock Images/Oksana Smyshliaeva The FDA has granted accelerated approval to Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), a…

Elrexfio Shows Deep and Durable Responses Extending Survival in Relapsed or Refractory Multiple Myeloma
Medicine

Elrexfio Shows Deep and Durable Responses Extending Survival in Relapsed or Refractory Multiple Myeloma

adminJune 16, 2024June 16, 2024

Image credit: LASZLO | stock.adobe.com Findings from the Phase II MagnetisMM-3 trial (NCT04649359) showed a significant survival benefit with Elrexfio…

Improving Quality of Care for Cancer Patients
Medicine

Improving Quality of Care for Cancer Patients

adminJune 15, 2024June 15, 2024

ACT: How can we improve shared decision-making practices as ways to improve the quality of care for cancer patients? Buyse:…

EQT Acquires Majority Stake in CluePoints
Medicine

EQT Acquires Majority Stake in CluePoints

adminJune 14, 2024June 14, 2024

Image Credit: © lidiia – stock.adobe.com EQT has announced that the EQT Healthcare Growth Strategy and the EQT Growth Fund…

Designing Trials to Consider the Full Spectrum of Patient Outcomes
Medicine

Designing Trials to Consider the Full Spectrum of Patient Outcomes

adminJune 14, 2024June 14, 2024

ACT: How is clinical trial design and analysis changing in response to more comprehensive evaluation methods (methods that consider the…

Bimzelx Shows Long-Term Efficacy Treating Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
Medicine

Bimzelx Shows Long-Term Efficacy Treating Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis

adminJune 13, 2024

Image credit: Sweettymojidesign | stock.adobe.com Two-year data from the Phase III BE MOBILE 1, BE MOBILE 2, and the open-label…

Transforming Cancer Care Through Patient-Centered Research
Medicine

Transforming Cancer Care Through Patient-Centered Research

adminJune 13, 2024

ACT: How can we transform cancer care through more patient-centered research and treatment analysis? Buyse: Just building on what Sebastien…

Two-year Interim Analysis of Trial Data Show Sustained Efficacy of Seladelpar Treating Primary Biliary Cholangitis
Medicine

Two-year Interim Analysis of Trial Data Show Sustained Efficacy of Seladelpar Treating Primary Biliary Cholangitis

adminJune 12, 2024

Image credit: Crystal light | stock.adobe.com Two-year interim data from the Phase III ASSURE trial (NCT03301506) show sustained and long-term…

Challenges in Oncology Trials: Analyzing Endpoints
Medicine

Challenges in Oncology Trials: Analyzing Endpoints

adminJune 12, 2024June 12, 2024

ACT: What are some of the unique challenges facing oncology trials today? Buyse: Well, I think there are many challenges,…

Applied Clinical Trials June 2024 Issue (PDF)
Medicine

Applied Clinical Trials June 2024 Issue (PDF)

adminJune 11, 2024

Applied Clinical Trials June 2024 Issue (PDF) Sustainability: More than Meets the Eye Status Check: Science & Sustainability Aligning Patient…

Can Large Language Models Accurately Assess Risk of Bias in Randomized Clinical Trials?
Medicine

Can Large Language Models Accurately Assess Risk of Bias in Randomized Clinical Trials?

adminJune 11, 2024

Image Credit: © putilov_denis – stock.adobe.com Systematic reviews are a key element of clinical research. While these reviews must be…

An Updated View of Industry Trends
Medicine

An Updated View of Industry Trends

adminJune 10, 2024

Image Credit: © Murrstock – stock.adobe.com We presented an initial review of quality tolerance limit (QTL) adoption trends in the…

Elahere Achieves Primary, Key Secondary Endpoint in Phase II Trial Treating Platinum-Sensitive Ovarian Cancer
Medicine

Elahere Achieves Primary, Key Secondary Endpoint in Phase II Trial Treating Platinum-Sensitive Ovarian Cancer

adminJune 10, 2024

Image credit: Dr_Microbe | stock.adobe.com Elahere (mirvetuximab soravtansine; AbbVie) achieved both the primary and secondary endpoints of the Phase II…

Amid Heightened Industry Rules on Sustainability, How are CROs Faring?
Medicine

Amid Heightened Industry Rules on Sustainability, How are CROs Faring?

adminJune 9, 2024

Image Credit: © Supapeach – stock.adobe.com A few points to review before we reach the heart of this how-green-are-they-getting look…

First Patient Treated With Investigational ABBV-383 in CERVINO Phase III Study for Multiple Myeloma
Medicine

First Patient Treated With Investigational ABBV-383 in CERVINO Phase III Study for Multiple Myeloma

adminJune 9, 2024

Image Credit: © Катерина Євтехова – stock.adobe.com AbbVie has announced that the first patient has been treated with its investigational…

Sustainability in Clinical Trials: Purposeful Digitalization is Key
Medicine

Sustainability in Clinical Trials: Purposeful Digitalization is Key

adminJune 8, 2024

Julia Sundari, Senior Director of Clinical Design and Analytics, IQVIA In 2023, clinical development productivity rose the highest it has…

Aligning Patient Burden with Planetary Burden
Medicine

Aligning Patient Burden with Planetary Burden

adminJune 8, 2024

Michael Cohen, Senior Director, Lead, Environmental Sustainability Robyn Owens, Manager, Recruitment and Engagement Both with the PPD clinical research business…

Understanding Heuristics and Biases in Clinical Trial Decision-Making
Medicine

Understanding Heuristics and Biases in Clinical Trial Decision-Making

adminJune 7, 2024June 7, 2024

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. In our journey through the lessons of cognitive,…

How Much Does a Day of Delay in a Clinical Trial Really Cost?
Medicine

How Much Does a Day of Delay in a Clinical Trial Really Cost?

adminJune 7, 2024

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of…

FDA and CluePoints Extend Existing Collaboration to Include AI/ML for Quality Assessment
Medicine

FDA and CluePoints Extend Existing Collaboration to Include AI/ML for Quality Assessment

adminJune 6, 2024

Image Credit: © Murrstock – stock.adobe.com FDA and CluePoints have announced a new 3-year extension to their long-standing collaboration. The…

New Data From Phase III MARIPOSA Study Presented at ASCO Show Groundbreaking Results for RYBREVANT Combination in NSCLC Patients
Medicine

New Data From Phase III MARIPOSA Study Presented at ASCO Show Groundbreaking Results for RYBREVANT Combination in NSCLC Patients

adminJune 6, 2024

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Johnson & Johnson has announced new data from the Phase III MARIPOSA study…

Data From Phase III PALOMA-3 Study for NSCLC Presented at ASCO Show Five-Fold Reduction in Infusion-Related Reactions
Medicine

Data From Phase III PALOMA-3 Study for NSCLC Presented at ASCO Show Five-Fold Reduction in Infusion-Related Reactions

adminJune 5, 2024

Image Credit: © iDoPixBox – stock.adobe.com Johnson & Johnson has announced first data from the Phase III PALOMA-3 study for…

The Future of BYOD Adoption
Medicine

The Future of BYOD Adoption

adminJune 5, 2024

ACT: Looking forward, what does the future of bring-your-own-device (BYOD) adoption look like? Liu: I think it’s already common. I…

Differentiating Consumer- and Medical-Grade Wearables
Medicine

Differentiating Consumer- and Medical-Grade Wearables

adminJune 4, 2024

ACT: What are the differences between consumer- and medical- grade wearables and their uses in clinical settings? Liu: The medical grade…

A Multiomic Roadmap to Success
Medicine

A Multiomic Roadmap to Success

adminJune 4, 2024June 4, 2024

Image Credit: © Kaikoro – stock.adobe.com Conversations around the impact of artificial intelligence (AI) in the pharmaceutical industry seem to…

Quickly connect the right participants to your trial
Medicine

Quickly connect the right participants to your trial

adminJune 3, 2024

Meet your enrollment goals faster by recruiting from Evidation’s engaged, highly characterized health community.

Datopotamab Deruxtecan Achieves Superior Survival Compared to Chemo in Advanced Nonsquamous NSCLC
Medicine

Datopotamab Deruxtecan Achieves Superior Survival Compared to Chemo in Advanced Nonsquamous NSCLC

adminJune 3, 2024

Image credit: Axel Kock | stock.adobe.com Results from the TROPION-Lung01 Phase III trial (NCT04656652) show datopotamab deruxtecan (Dato-DXd) achieved superior…

Optimizing Remote Monitoring With FSP: Adapting to the New Normal
Medicine

Optimizing Remote Monitoring With FSP: Adapting to the New Normal

adminJune 2, 2024

Webinar Date/Time: Tuesday, June 25th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

FDA Extends PDUFA Date for Dupixent in COPD, Requesting Additional Data From BOREAS and NOTUS Trials
Medicine

FDA Extends PDUFA Date for Dupixent in COPD, Requesting Additional Data From BOREAS and NOTUS Trials

adminJune 2, 2024

Image credit: art4stock | stock.adobe.com The FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date by…

Breyanzi Gets FDA Approval to Treat Relapsed/Refractory Mantle Cell Lymphoma
Medicine

Breyanzi Gets FDA Approval to Treat Relapsed/Refractory Mantle Cell Lymphoma

adminJune 1, 2024

Image credit: David A Litman | stock.adobe.com The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults…

ConcertAI Introduces New Artificial Intelligence Solutions Powered by Real-World Data
Medicine

ConcertAI Introduces New Artificial Intelligence Solutions Powered by Real-World Data

adminJune 1, 2024

Image Credit: © Shuo – stock.adobe.com ConcertAI has announced its first-in-category predictive and generative artificial intelligence (AI) solutions. The new…

Optimizing Technology Implementation to Improve Diversity in Clinical Research
Medicine

Optimizing Technology Implementation to Improve Diversity in Clinical Research

adminMay 31, 2024

Image Credit: © Jakub Krechowicz – stock.adobe.com Inclusion of diverse populations continues to lag in clinical research. In this article,…

Challenges With BYOD in Clinical Trials
Medicine

Challenges With BYOD in Clinical Trials

adminMay 31, 2024May 31, 2024

ACT: What are some challenges we are currently seeing with data security and accuracy in bring-your-own-device (BYOD) models? Liu: The…

An Overview of FDA Diversity-Related Documents for Clinical Trials
Medicine

An Overview of FDA Diversity-Related Documents for Clinical Trials

adminMay 30, 2024

Image credit: GraphicPapa | stock.adobe.com Since 2016, the FDA has released various guidance documents intended to promote diversity in clinical…

Lexicon Pharmaceuticals Selects Medidata to Aid in Advancing Phase IIb Trial of Non-Opioid Drug for Neuropathic Pain
Medicine

Lexicon Pharmaceuticals Selects Medidata to Aid in Advancing Phase IIb Trial of Non-Opioid Drug for Neuropathic Pain

adminMay 30, 2024

Image Credit: © photon_photo – stock.adobe.com Medidata has announced it has been selected by Lexicon Pharmaceuticals to help advance the…

Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical Trials
Medicine

Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical Trials

adminMay 29, 2024

Image Credit: © Murrstock – stock.adobe.com With ambitious goals to accelerate clinical trials, increase efficiency, and lower costs, many leading…

Phase II Triple Combo Trial of Osemitamab for Gastric/Gastroesophageal Adenocarcinoma Produces Encouraging Results
Medicine

Phase II Triple Combo Trial of Osemitamab for Gastric/Gastroesophageal Adenocarcinoma Produces Encouraging Results

adminMay 29, 2024

Image Credit: © PIC4U – stock.adobe.com Transcenta has announced results from the Phase I/IIa Cohort-G data for Osemitamab (TST001) plus…

What’s Complicating Good Data Practices and Data Integrity?
Medicine

What’s Complicating Good Data Practices and Data Integrity?

adminMay 28, 2024

Image credit: metamorworks | stock.adobe.com Data integrity is an ongoing concern across all R&D organizations, no matter what part of…

Mapping Baseline ChatGPT Usage to Support Drug Development
Medicine

Mapping Baseline ChatGPT Usage to Support Drug Development

adminMay 28, 2024May 28, 2024

Image credit: Tierney | stock.adobe.com Abstract Background: ChatGPT usage remains limited to administrative and support work among drug developments professionals;…

Q&A with Jeremy Wyatt, CEO of ActiGraph
Medicine

Q&A with Jeremy Wyatt, CEO of ActiGraph

adminMay 27, 2024

Jeremy Wyatt, CEO of ActiGraph The technology that goes into wearable health monitoring devices has advanced by leaps and bounds…

Strategies and eCOA Best Practices in Drug Development
Medicine

Strategies and eCOA Best Practices in Drug Development

adminMay 27, 2024

Mike Hughes, Chief Product Officer, YPrime The field of drug development is placing a growing emphasis on the importance of…

Phastar and Beaconcure Announce Partnership, Enhance Data Review in Clinical Trials
Medicine

Phastar and Beaconcure Announce Partnership, Enhance Data Review in Clinical Trials

adminMay 26, 2024

Image Credit: © Murrstock – stock.adobe.com Beaconcure, a provider of artificial intelligence-enabled clinical data validation and automation, has announced a…

Nimbus’ Phase 1/2 Trial for NDI-101150 Shows Promise in Treating Advanced Solid Tumors
Medicine

Nimbus’ Phase 1/2 Trial for NDI-101150 Shows Promise in Treating Advanced Solid Tumors

adminMay 26, 2024

Image Credit: Adobe Stock Images/Hero Design Nimbus Therapeutics presented promising data from its Phase 1/2 clinical trial of NDI-101150, a…

Clario Partners With Emsere, Extends Ophthalmic Medical Imaging Capabilities
Medicine

Clario Partners With Emsere, Extends Ophthalmic Medical Imaging Capabilities

adminMay 25, 2024

Image Credit: © lidiia – stock.adobe.com Clario has announced a strategic partnership with medical equipment supplier for clinical trials, Emsere.…

The Critical Role of Contracting in Research
Medicine

The Critical Role of Contracting in Research

adminMay 25, 2024

Image Credit: © ipopba – stock.adobe.com From the promise of shrinking pancreatic tumors to a vaccine for Alzheimer’s, groundbreaking clinical…

Sanofi’s Phase II Trial of Rilzabrutinib Shows Clinically Meaningful Reduction in Loss of Asthma Control
Medicine

Sanofi’s Phase II Trial of Rilzabrutinib Shows Clinically Meaningful Reduction in Loss of Asthma Control

adminMay 24, 2024

Image Credit: Adobe Stock Images/Antonioguillem Sanofi announced positive results from a Phase II study for rilzabrutinib, a promising first-of-its-kind advanced…

Boehringer Ingelheim and OSE Immunotherapeutics Announce Expansion of Two Solid Tumor Programs
Medicine

Boehringer Ingelheim and OSE Immunotherapeutics Announce Expansion of Two Solid Tumor Programs

adminMay 24, 2024May 24, 2024

Image Credit: © Aerial Mike – stock.adobe.com Boehringer Ingelheim and OSE Immunotherapeutics have announced a major expansion of their already-existing…

Edgewood Oncology Doses First Two Patients in Phase IIa Study for BTX-A51, a Potential Treatment for Metastatic Breast Cancer
Medicine

Edgewood Oncology Doses First Two Patients in Phase IIa Study for BTX-A51, a Potential Treatment for Metastatic Breast Cancer

adminMay 23, 2024

Image Credit: Adobe Stock Images/Oksana Smyshliaeva Edgewood Oncology announced that it has begun dosing patients as part of a Phase…

Identifying Relevant Randomized Clinical Trial Questions for Hospitalized Children
Medicine

Identifying Relevant Randomized Clinical Trial Questions for Hospitalized Children

adminMay 23, 2024

Image Credit: © Egor – stock.adobe.com While the number of randomized clinical trials (RCTs) for adult participants has increased over…

US Pharma and Biotech Summit 2024: Evolving Clinical Research
Medicine

US Pharma and Biotech Summit 2024: Evolving Clinical Research

adminMay 22, 2024

Image Credit: © Aerial Mike – stock.adobe.com In a presentation at the 2024 US Pharma and Biotech Summit, Michael Peel,…

GSK Presents Positive Results from SWIFT-1 and SWIFT-2, Phase III Trials Evaluating Depemokimab in Adults and Adolescents with Severe Asthma
Medicine

GSK Presents Positive Results from SWIFT-1 and SWIFT-2, Phase III Trials Evaluating Depemokimab in Adults and Adolescents with Severe Asthma

adminMay 22, 2024

Image Credit: Adobe Stock Images/Sebastian Kaulitzki GSK announced promising results from its Phase III clinical trials, SWIFT-1 and SWIFT-2, evaluating…

Comparing End Points Between Non-Small Cell Lung Cancer Clinical Trials, Observational Studies
Medicine

Comparing End Points Between Non-Small Cell Lung Cancer Clinical Trials, Observational Studies

adminMay 21, 2024

Image Credit: © iDoPixBox – stock.adobe.com A study recently published in JAMA Network Open compared response- and progression-based end points…

Eli Lilly Reveals Promising Results from QWINT-2 and QWINT-4 Phase III Trials for Efsitora Alfa, a Weekly Insulin Treatment for Adults with Type 2 Diabetes
Medicine

Eli Lilly Reveals Promising Results from QWINT-2 and QWINT-4 Phase III Trials for Efsitora Alfa, a Weekly Insulin Treatment for Adults with Type 2 Diabetes

adminMay 21, 2024

Image Credit: Adobe Stock Images/Robert Kneschke Eli Lilly announced promising results from the QWINT-2 and QWINT-4 Phase III trials for…

Potential Pitfalls Without RBQM Adoption
Medicine

Potential Pitfalls Without RBQM Adoption

adminMay 20, 2024

ACT: If companies choose not to adopt risk-based approaches, what are some of the largest risks they leave themselves susceptible…

Where Innovation and Patients Meet to Improve Cancer Care
Medicine

Where Innovation and Patients Meet to Improve Cancer Care

adminMay 20, 2024

David Alsadius, MD, PhD, Senior Medical Director, Oncology Center of Excellence, IQVIA Sergio Sánchez-Gambetta Director, Design Analytics, IQVIA Matt Simmons…

Roche’s Novel Dual GLP-1/GIP Receptor Agonist Produces Clinically Meaningful Weight Loss in Phase Ib Trial
Medicine

Roche’s Novel Dual GLP-1/GIP Receptor Agonist Produces Clinically Meaningful Weight Loss in Phase Ib Trial

adminMay 19, 2024May 19, 2024

Image credit: 9dreamstudio | stock.adobe.com Roche’s dual GLP-1/GIP receptor agonist CT-388 produced positive findings treating obesity and type 2 diabetes…

Putting LP-284 on the Industry RADR
Medicine

Putting LP-284 on the Industry RADR

adminMay 19, 2024

Panna Sharma, CEO, Lantern Pharma ACT: While reaching the first-in-human stage is a significant achievement, what specific endpoints or biomarkers…

The Future of RBQM Adoption
Medicine

The Future of RBQM Adoption

adminMay 18, 2024

ACT: What do you think the RBQM space will look like in five years? Will we see any drastic changes…

Four-Year Data from Long-Term Extension Trial Show Efficacy of Sotyktu Treating Moderate-to-Severe Plaque Psoriasis
Medicine

Four-Year Data from Long-Term Extension Trial Show Efficacy of Sotyktu Treating Moderate-to-Severe Plaque Psoriasis

adminMay 18, 2024

Image credit: Ban | stock.adobe.com Four-year data from the long-term extension (LTE) of the POETYK PSO clinical trial program found…

A Promising Future for Oncology R&D
Medicine

A Promising Future for Oncology R&D

adminMay 17, 2024

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Oncology clinical trials have always been a unique area in the…

Applied Clinical Trials May 2024 Issue (PDF)
Medicine

Applied Clinical Trials May 2024 Issue (PDF)

adminMay 17, 2024

Applied Clinical Trials May 2024 Issue (PDF) A Promising Future for Oncology R&D Where Innovation and Patients Meet to Improve…

Eisai and Biogen Start Rolling Biologics License Application Submission to FDA for Subcutaneous Version of Alzheimer Disease Drug Leqembi
Medicine

Eisai and Biogen Start Rolling Biologics License Application Submission to FDA for Subcutaneous Version of Alzheimer Disease Drug Leqembi

adminMay 16, 2024

Image credit: Dr_Microbe | stock.adobe.com Eisai and Biogen Inc. have initiated a rolling FDA submission for a subcutaneous (SC) version…

A Fun and Insightful Exploration of Behavioral Science
Medicine

A Fun and Insightful Exploration of Behavioral Science

adminMay 16, 2024

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. This installment of my column is a little…

Outsourcing in Clinical Trials East Coast 2024 (5/21-5/22)
Medicine

Outsourcing in Clinical Trials East Coast 2024 (5/21-5/22)

adminMay 15, 2024

Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget. Join us for a…

Accelerating the Progress of Kinase Inhibitors in Oncology
Medicine

Accelerating the Progress of Kinase Inhibitors in Oncology

adminMay 15, 2024

Hannah Jones, PhD, Senior Vice President, PBPK Consultancy Services, Certara Masoud Jamei, PhD, Senior Vice President, Research and Development, Certara More…

Merck Discontinues Coformulation Arm of Phase III Trial Evaluating Vibostolimab/Keytruda Combo for Melanoma
Medicine

Merck Discontinues Coformulation Arm of Phase III Trial Evaluating Vibostolimab/Keytruda Combo for Melanoma

adminMay 14, 2024

Image credit: Ocskay Mark | stock.adobe.com Merck is discontinuing the coformulation arm of the Phase III KeyVibe-010 trial (NCT05665595) analyzing…

Opdivo and Yervoy Combination Misses Primary Endpoint in Phase III Trial for NSCLC
Medicine

Opdivo and Yervoy Combination Misses Primary Endpoint in Phase III Trial for NSCLC

adminMay 14, 2024

Image Credit: © iDoPixBox – stock.adobe.com In an update on the Phase III CheckMate -73L trial, Bristol Myers Squibb announced…

Overcoming Challenges in the Development of Antibody Drug Conjugates
Medicine

Overcoming Challenges in the Development of Antibody Drug Conjugates

adminMay 13, 2024

Andreas Dreps, Senior VP and Global Head Drug Development Unit, ICON plc Over the years, extensive research and clinical trials…

Investigational Gene Therapy Produces Significant Hearing Improvements in Children Born with Profound Genetic Deafness
Medicine

Investigational Gene Therapy Produces Significant Hearing Improvements in Children Born with Profound Genetic Deafness

adminMay 13, 2024May 13, 2024

Image credit: florence | stock.adobe.com In the Phase I/II CHORD trial (NCT05788536), a novel gene therapy was found to restore…

Keytruda Combination Falls Short of Disease-Free Survival Primary Endpoint in Phase III Trial for High-Risk Endometrial Cancer
Medicine

Keytruda Combination Falls Short of Disease-Free Survival Primary Endpoint in Phase III Trial for High-Risk Endometrial Cancer

adminMay 12, 2024

Image credit: MdBabul | stock.adobe.com Keytruda (pembrolizumab; Merck) plus chemotherapy as adjuvant therapy, with or without radiotherapy, in the treatment of…

Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC
Medicine

Ken Getz of Tufts CSDD Discusses RBQM Study Conducted with CluePoints and PwC

adminMay 12, 2024

ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts? Getz: Yes,…

FDA Delays Review of BLA Submission for Moderna’s Novel Respiratory Syncytial Virus Vaccine
Medicine

FDA Delays Review of BLA Submission for Moderna’s Novel Respiratory Syncytial Virus Vaccine

adminMay 11, 2024

Image credit: JHVEPhoto | stock.adobe.com The FDA has notified Moderna that it will be unable to finish reviewing its Biologics…

Tufts CSDD Vendor Qualification Survey
Medicine

Tufts CSDD Vendor Qualification Survey

adminMay 11, 2024

Image Credit: © NicoElNino – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD) is conducting an…

The Role of Social Determinants of Health in Cancer Clinical Trial Availability
Medicine

The Role of Social Determinants of Health in Cancer Clinical Trial Availability

adminMay 10, 2024

Image Credit: © putilov_denis – stock.adobe.com Patient enrollment has been a persistent challenge in clinical trials over the years across…

Conference Calls for Unity in Addressing Artificial Intelligence Regulation in Life Sciences Research and Development
Medicine

Conference Calls for Unity in Addressing Artificial Intelligence Regulation in Life Sciences Research and Development

adminMay 10, 2024

Image Credit: Adobe Stock Images/_veiksme_ The Pistoia Alliance, a prominent non-profit advocating for increased collaboration in life sciences R&D, announced…

Challenges in Conducting Multicentric Infectious Giardia Diarrhea Clinical Studies in India
Medicine

Challenges in Conducting Multicentric Infectious Giardia Diarrhea Clinical Studies in India

adminMay 9, 2024

Image credit: Jafree | stock.adobe.com Diarrheal diseases place a significant burden on public health in India, particularly among children and…

FDA Grants Breakthrough Device Designation for At-Home Self-Collect Cervical Cancer Screening Device
Medicine

FDA Grants Breakthrough Device Designation for At-Home Self-Collect Cervical Cancer Screening Device

adminMay 9, 2024

Image Credit: © ibreakstock | stock.adobe.com The FDA has granted Breakthrough Device Designation for Teal Health’s Teal Wand, a novel…

First Worldwide Clinical Trial for Diabetic Macular Ischemia​ Treatment Achieves Primary Safety Endpoints
Medicine

First Worldwide Clinical Trial for Diabetic Macular Ischemia​ Treatment Achieves Primary Safety Endpoints

adminMay 8, 2024

Image credit: koolsabuy | stock.adobe.com The first ever clinical trial conducted to evaluate an experimental treatment for diabetic macular ischemia…

FDA Clears Investigational New Drug Application for Novel BD2-Selective BET Inhibitor, VYN202
Medicine

FDA Clears Investigational New Drug Application for Novel BD2-Selective BET Inhibitor, VYN202

adminMay 8, 2024

Image Credit: © Murrstock – stock.adobe.com The FDA has cleared an Investigational New Drug Application (IND) for VYNE Therapeutics’ VYN202,…

Novel Therapy Achieves Durable Complete Response Rate Treating High-Risk Bladder Cancer in Phase II Trial
Medicine

Novel Therapy Achieves Durable Complete Response Rate Treating High-Risk Bladder Cancer in Phase II Trial

adminMay 7, 2024

Image credit: magicmine | stock.adobe.com Data from a Phase II trial for Johnson & Johnson’s novel targeted therapy TAR-200 showed…

Are Event Rates and Effect Sizes Reported Accurately in Cardiovascular Trials?
Medicine

Are Event Rates and Effect Sizes Reported Accurately in Cardiovascular Trials?

adminMay 7, 2024

Image Credit: © Tierney – stock.adobe.com In the design of a randomized clinical trial (RCT), estimations for expected event rate…

A New Approach for Sponsors and Sites
Medicine

A New Approach for Sponsors and Sites

adminMay 6, 2024

Are you interested in learning about clinical trial participant payment best practices? Join IQVIA Technologies to learn how an innovative…

Ensuring Patient Centricity With AI
Medicine

Ensuring Patient Centricity With AI

adminMay 6, 2024

ACT: How is artificial intelligence (AI) currently being used in clinical trials to ensure patient centricity? Nambisan: I think it’s…

Safeguarding Against Trial Complexities With Feasibility Studies
Medicine

Safeguarding Against Trial Complexities With Feasibility Studies

adminMay 5, 2024

ACT: How can feasibility studies be used to safeguard against trial complexities? Nambisan: So I touched on this just briefly…

Challenges With Feasibility Studies
Medicine

Challenges With Feasibility Studies

adminMay 5, 2024

ACT: What are some of the biggest mistakes stakeholders tend to make with their feasibility studies? How can those challenges…

Tips to Rescue a Clinical Trial Before It’s Too Late
Medicine

Tips to Rescue a Clinical Trial Before It’s Too Late

adminMay 4, 2024

Elizabeth Kelchner is the Associate Director of Data Management at Rho Sometimes relationships can continue even when things aren’t working out. However,…

Leveraging Innovative Trial Designs and Advanced Imaging Techniques
Medicine

Leveraging Innovative Trial Designs and Advanced Imaging Techniques

adminMay 4, 2024

Image credit: Juan Gärtner | stock.adobe.com The landscape of oncology drug development is rapidly evolving, particularly in the realm of…

First-Line Treatment with Calquence Plus Chemoimmunotherapy Found to Improve Survival in Patients with Mantle Cell Lymphoma
Medicine

First-Line Treatment with Calquence Plus Chemoimmunotherapy Found to Improve Survival in Patients with Mantle Cell Lymphoma

adminMay 3, 2024

Image credit: David A Litman | stock.adobe.com Calquence (acalabrutinib; AstraZeneca) plus standard-of-care chemoimmunotherapy produced a statistically significant and clinically meaningful improvement…

Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity
Medicine

Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity

adminMay 3, 2024

Image Credit: Adobe Stock Images/freshidea Walgreens and Boehringer Ingelheim have announced a joint venture, which will focus on the growth…

Keytruda Combination Achieves Overall Survival Improvement in HER2-Positive Advanced Gastric or GEJ Adenocarcinoma
Medicine

Keytruda Combination Achieves Overall Survival Improvement in HER2-Positive Advanced Gastric or GEJ Adenocarcinoma

adminMay 2, 2024

Image credit: Crystal light | stock.adobe.com Merck’s Keytruda (pembrolizumab) combined with trastuzumab, plus fluoropyrimidine- and platinum-containing chemotherapy, demonstrated promising improvements in…

What are the Most Common Barriers to Community Cancer Centers Engaging in Clinical Trials?
Medicine

What are the Most Common Barriers to Community Cancer Centers Engaging in Clinical Trials?

adminMay 2, 2024

Image Credit: © peshkova – stock.adobe.com An overwhelming amount of cancer patients express willingness to participate in clinical trials; however,…

Novel 21-Valent Pneumococcal Conjugate Vaccine for Adults Shows Positive Data in Phase III Trial
Medicine

Novel 21-Valent Pneumococcal Conjugate Vaccine for Adults Shows Positive Data in Phase III Trial

adminMay 1, 2024

Image credit: Jezper | stock.adobe.com Data from the Phase III STRIDE-10 trial show the promise of Merck’s novel 21-valent pneumococcal…

Tailoring AI Regulation in Healthcare
Medicine

Tailoring AI Regulation in Healthcare

adminMay 1, 2024

Image Credit: © Shuo – stock.adobe.com As artificial intelligence (AI) technology rapidly evolves, regulators around the world are tasked with…

Parexel and Palantir Expand Collaboration to Leverage AI Capabilities in Clinical Trials
Medicine

Parexel and Palantir Expand Collaboration to Leverage AI Capabilities in Clinical Trials

adminApril 30, 2024

Image Credit: © lidiia – stock.adobe.com Parexel and Palantir Technologies have announced a new multi-year strategic partnership to leverage artificial…

The Future of Drug Discovery
Medicine

The Future of Drug Discovery

adminApril 30, 2024

Image credit: NicoElNino | stock.adobe.com Artificial intelligence (AI) has become a cornerstone in the healthcare and pharmaceutical industry. The introduction…

Creating Standardized eCOA Solutions
Medicine

Creating Standardized eCOA Solutions

adminApril 29, 2024

ACT: How can differences across therapeutic areas be used to create more standardized electronic clinical outcome assessment (eCOA) solutions? Mooney:…

FDA Grants Priority Review to sBLA for Jemperli plus Chemotherapy for Adults with Primary Advanced, Recurrent Endometrial Cancer
Medicine

FDA Grants Priority Review to sBLA for Jemperli plus Chemotherapy for Adults with Primary Advanced, Recurrent Endometrial Cancer

adminApril 29, 2024

Image credit: Crystal light | stock.adobe.com The FDA has granted Priority Review to GSK’s supplemental Biologics License Application (sBLA) seeking…

Using Patient Reported Outcomes in Dermatology Trials
Medicine

Using Patient Reported Outcomes in Dermatology Trials

adminApril 28, 2024

ACT: Specifically in dermatology trials, which provide a lot of unique challenges, could you discuss some of the best practices…

Regulatory Compliance With eCOAs
Medicine

Regulatory Compliance With eCOAs

adminApril 28, 2024

ACT: Are there currently any regulatory challenges with the use of electronic clinical outcome assessments (eCOAs)? If so, how can…

FDA Grants Fast Track Designation to Novel Bispecific Antibody Plus Paclitaxel for Advanced Biliary Tract Cancer
Medicine

FDA Grants Fast Track Designation to Novel Bispecific Antibody Plus Paclitaxel for Advanced Biliary Tract Cancer

adminApril 27, 2024

Image credit: Matthieu | stock.adobe.com Compass Therapeutics, Inc’s novel bispecific antibody CTX-009 was granted Fast Track Designation (FTD) by the…

Why We Need to Harness Real-Time Data to Truly Drive Diversity in Clinical Trials
Medicine

Why We Need to Harness Real-Time Data to Truly Drive Diversity in Clinical Trials

adminApril 27, 2024

Monique Adams, PhD, Executive Director, Global Head of Diversity & Inclusion in Clinical Trials, Sanofi The lack of diversity in…

Do Assigned Roles in Clinical Trials Affect Patient-Reported Outcomes?
Medicine

Do Assigned Roles in Clinical Trials Affect Patient-Reported Outcomes?

adminApril 26, 2024April 26, 2024

Image Credit: © Andrii Yalanskyi – stock.adobe.com A study recently published on JAMA Network Open examined a single center, double-blind,…

Rinvoq Found Superior to Dupixent in Key Endpoints of Open-Label Trial Treating Atopic Dermatitis
Medicine

Rinvoq Found Superior to Dupixent in Key Endpoints of Open-Label Trial Treating Atopic Dermatitis

adminApril 26, 2024

Image credit: InfiniteStudio | stock.adobe.com Findings from the Phase IIIb/IV LEVEL UP (NCT05601882) trial demonstrated the superiority of AbbVie’s Rinvoq (upadacitinib)…

Comparing the Characteristics of Type 2 Diabetes Patients in General Practices and Those in Randomized Controlled Trials
Medicine

Comparing the Characteristics of Type 2 Diabetes Patients in General Practices and Those in Randomized Controlled Trials

adminApril 25, 2024

Image Credit: © Proxima Studio – stock.adobe.com A study recently published in BMJ Open has identified differences in the characteristics…

Q&A With Rust Felix, CEO and Co-founder of Slope
Medicine

Q&A With Rust Felix, CEO and Co-founder of Slope

adminApril 25, 2024

Rust Felix, CEO and Co-founder of Slope While the potential of artificial intelligence (AI) has become more popular in the…

FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
Medicine

FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia

adminApril 24, 2024

Image credit: MdBabul | stock.adobe.com Kura Oncology’s ziftomenib has been granted Breakthrough Therapy Designation (BTD) by the FDA for heavily…

The Consequences of Underrepresentation in Clinical Trial Design
Medicine

The Consequences of Underrepresentation in Clinical Trial Design

adminApril 24, 2024

Image credit: Pixel-Shot | stock.adobe.com Clinical trials are opportunities to advance how we diagnose, treat, and prevent disease, as well…

CDC Case Data Highlight Importance of Children and Adolescents Remaining Up to Date with COVID-19 Vaccinations
Medicine

CDC Case Data Highlight Importance of Children and Adolescents Remaining Up to Date with COVID-19 Vaccinations

adminApril 23, 2024April 23, 2024

Image credit: neirfy | stock.adobe.com A new report from the Centers for Disease Control and Prevention (CDC) demonstrates the efficacy…

Utilizing COAs Across Different Therapeutic Areas
Medicine

Utilizing COAs Across Different Therapeutic Areas

adminApril 23, 2024

ACT: How does the utilization of clinical outcome assessments (COAs) differ across the various therapeutic areas? Mooney: That’s a great…

Long-Term Treatment with Kesimpta Shows Sustained Efficacy in Recently Diagnosed, Treatment-Naïve Patients with Relapsing MS
Medicine

Long-Term Treatment with Kesimpta Shows Sustained Efficacy in Recently Diagnosed, Treatment-Naïve Patients with Relapsing MS

adminApril 22, 2024

Image credit: Nathan Devery com | stock.adobe.com Results from the open-label ALITHIOS extension study demonstrated the long-term efficacy of first-line,…

What is the Current State of Remote Monitoring in Oncology Clinical Trials?
Medicine

What is the Current State of Remote Monitoring in Oncology Clinical Trials?

adminApril 22, 2024

Image Credit: © Blue Planet Studio – stock.adobe.com A recent survey study published on JAMA Network Open sought to evaluate…

Enabling Evidence-Based Study Endpoint Selection
Medicine

Enabling Evidence-Based Study Endpoint Selection

adminApril 21, 2024

Marcelo Alves Favaro, Associate Outcomes Researcher, MAPI Research Trust Caprice Sassano, Research Lead – Applied Sciences, HumanFirst, an ICON company…

Analysis of Randomized Clinical Trials Show Improved Survival with Neoadjuvant Immune Checkpoint Inhibitors Plus Chemotherapy for NSCLC
Medicine

Analysis of Randomized Clinical Trials Show Improved Survival with Neoadjuvant Immune Checkpoint Inhibitors Plus Chemotherapy for NSCLC

adminApril 21, 2024

Image credit: mi_viri | stock.adobe.com An analysis of eight randomized clinical trials (RCTs) found that the use of neoadjuvant platinum-based…

Is Japan Leading a New Digital Health Movement?
Medicine

Is Japan Leading a New Digital Health Movement?

adminApril 20, 2024

Dave Hanaman, President, Chief Commercial Officer, Co-Founder, Curavit Clinical Research. Japan’s digital health market is expected to show a compound…

The Evolving Landscape of DHTs
Medicine

The Evolving Landscape of DHTs

adminApril 20, 2024

Jill Sommerville, Senior Director Lauren Flood, Associate Director Matthew Ryan, Associate Director All with the digital and decentralized solutions for…

Navigating a Digital-Era Shift to Patient-Mediated Research
Medicine

Navigating a Digital-Era Shift to Patient-Mediated Research

adminApril 19, 2024

Vincent Keunen, Founder and CEO, Andaman7 New digital technologies are transforming possibilities in clinical research and driving a surge in…

To be, or not to be, that is the Question
Medicine

To be, or not to be, that is the Question

adminApril 19, 2024April 19, 2024

Image Credit: © Sergey Nivens – stock.adobe.com Generating insights from data based on structured patients’ reports dates back to 1980.1-3…

The Future Fit of Wearables for Patient-Centric Clinical Trials
Medicine

The Future Fit of Wearables for Patient-Centric Clinical Trials

adminApril 18, 2024April 18, 2024

Todd Rudo, MD, Chief Medical Officer, Clario Luc Dekie, PhD, Director of Scientific Affairs, Cardiology, Clario In an era prioritizing…

Patient Centricity: The Journey Matters
Medicine

Patient Centricity: The Journey Matters

adminApril 18, 2024

Bruce Hellman, Chief Patient Officer and Co-Founder, uMotif You’re setting forth on a long journey; you have your bags packed,…

Utilizing a Large Language Model to Answer Questions From Oncology Patients
Medicine

Utilizing a Large Language Model to Answer Questions From Oncology Patients

adminApril 17, 2024

Image Credit: © Shuo – stock.adobe.com A cross-sectional study recently published on JAMA Network Open analyzed the quality of responses…

FDA Accepts Phase III RECOVER-2 Study for Brilaroxazine in Schizophrenia
Medicine

FDA Accepts Phase III RECOVER-2 Study for Brilaroxazine in Schizophrenia

adminApril 17, 2024

Image Credit: © Egor – stock.adobe.com Reviva Pharmaceuticals has gained alignment from the FDA on its registrational Phase III program…

New Site Added to Phase I Trial of Lymphir for the Treatment of B-Cell Lymphoma
Medicine

New Site Added to Phase I Trial of Lymphir for the Treatment of B-Cell Lymphoma

adminApril 16, 2024

Image Credit: © peshkova – © peshkova – stock.adobe.com The University of Minnesota (UMN) Masonic Cancer Center is expected to…

Columvi Combination for Diffuse Large B-Cell Lymphoma Achieves Primary Endpoint of Overall Survival in Phase III Trial
Medicine

Columvi Combination for Diffuse Large B-Cell Lymphoma Achieves Primary Endpoint of Overall Survival in Phase III Trial

adminApril 16, 2024

Image credit: David A Litman | stock.adobe.com Data from the Phase III STARGLO trial (NCT04408638) show the combination of Columvi…

Trial Data Show Potential Benefit of Krazati Plus Cetuximab in KRAS-Mutated Locally Advanced or Metastatic Colorectal Cancer
Medicine

Trial Data Show Potential Benefit of Krazati Plus Cetuximab in KRAS-Mutated Locally Advanced or Metastatic Colorectal Cancer

adminApril 15, 2024

Image credit: Dr_Microbe | stock.adobe.com The combination of Krazati (adagrasib) plus cetuximab showed promise in patients with previously treated KRASG12C-mutated locally…

Benefits Patients Will See With the Integration of AI Into Clinical Research
Medicine

Benefits Patients Will See With the Integration of AI Into Clinical Research

adminApril 15, 2024

ACT: How much of a game-changer are artificial intelligence (AI) solutions to patients participating in clinical research? What are some…

Does Your eCOA Reduce Clinical Trial Risk?
Medicine

Does Your eCOA Reduce Clinical Trial Risk?

adminApril 14, 2024

April 5th 2024 Article Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing…

The Role of Human Oversight With Artificial Intelligence in Clinical Research
Medicine

The Role of Human Oversight With Artificial Intelligence in Clinical Research

adminApril 13, 2024April 13, 2024

ACT: How important is it that a level of human intervention remains with the oversight of these artificial intelligence (AI)…

Taking eCOA Delivery Off the Critical Path to First Patient In
Medicine

Taking eCOA Delivery Off the Critical Path to First Patient In

adminApril 13, 2024

Meeting the first patient in (FPI) deadline is a critical milestone for study teams who must first implement various systems…

Data From Phase III Extension Trial Show Long-Term Safety, Efficacy of Qulipta in Migraine Prevention
Medicine

Data From Phase III Extension Trial Show Long-Term Safety, Efficacy of Qulipta in Migraine Prevention

adminApril 12, 2024

Image credit: peterschreiber.media | stock.adobe.com Results from an interim analysis of an ongoing Phase III trial demonstrated the long-term safety…

Meta-Analysis of Randomized Clinical Trials Show Psilocybin for Depression, Anxiety Has Tolerable Adverse Effects
Medicine

Meta-Analysis of Randomized Clinical Trials Show Psilocybin for Depression, Anxiety Has Tolerable Adverse Effects

adminApril 12, 2024

Image credit: cendeced | stock.adobe.com An analysis of randomized, double-blind clinical trials found that psilocybin has a manageable adverse effect (AE)…

Generative AI-Enabled/Augmented Clinical Trials: The Road Ahead
Medicine

Generative AI-Enabled/Augmented Clinical Trials: The Road Ahead

adminApril 11, 2024

Image credit: Kaikoro | stock.adobe.com With the recent advances in generative AI (GenAI) with large language models (LLMs), GenAI-enabled or…

Q&A With Flo Mowlem of ObvioHealth
Medicine

Q&A With Flo Mowlem of ObvioHealth

adminApril 11, 2024

Flo Mowlem, PhD, VP of Science, ObvioHealth On March 25, ObvioHealth hosted a webinar on the execution of a medical…

Industry Collaboration in Advancing Clinical Technology
Medicine

Industry Collaboration in Advancing Clinical Technology

adminApril 10, 2024

ACT: Could you describe the importance of collaboration, specifically through data sharing, with regards to advancing the development of technology…

Phase III Trial Data Show Efficacy of Abrysvo in Adults Aged 18 to 59 Years with Elevated Risk of Severe RSV
Medicine

Phase III Trial Data Show Efficacy of Abrysvo in Adults Aged 18 to 59 Years with Elevated Risk of Severe RSV

adminApril 10, 2024

Image credit: jarun011 | stock.adobe.com Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produced positive safety and…

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