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Category: Medicine

Merck and Moderna Initiate Phase III Study of mRNA-4157 and Keytruda Combination for Non-Small Cell Lung Cancer
Medicine

Merck and Moderna Initiate Phase III Study of mRNA-4157 and Keytruda Combination for Non-Small Cell Lung Cancer

adminOctober 30, 2024October 30, 2024

Image Credit: © iDoPixBox – stock.adobe.com Merck and Moderna have announced the initiation of a Phase III clinical trial evaluating…

Tremfya Achieves Significant Clinical Remission, Endoscopic Response in Moderate to Severe Crohn Disease at 48 Weeks
Medicine

Tremfya Achieves Significant Clinical Remission, Endoscopic Response in Moderate to Severe Crohn Disease at 48 Weeks

adminOctober 29, 2024October 29, 2024

Credit: Uladzislau | stock.adobe.com Patients with moderate to severe Crohn disease (CD) administered treatment with subcutaneous (SC) Tremfya (guselkumab) achieved…

4 Perspectives on Sustainability in Clinical Research
Medicine

4 Perspectives on Sustainability in Clinical Research

adminOctober 29, 2024

Sustainability in clinical research is key. As complexity and productivity in the industry continue to rise, so does the need…

Omvoh Achieves Long-Term Remission, Symptom Improvement for Ulcerative Colitis, Crohn Disease in Phase III Trials
Medicine

Omvoh Achieves Long-Term Remission, Symptom Improvement for Ulcerative Colitis, Crohn Disease in Phase III Trials

adminOctober 28, 2024October 28, 2024

Credit: antkevyv | stock.adobe.com A pair of multiyear Phase III trials show that Eli Lilly’s Omvoh (mirikizumab) produced stable, long-term…

EHR-to-EDC Technology for Cancer Clinical Trials: Review of Research Webinar
Medicine

EHR-to-EDC Technology for Cancer Clinical Trials: Review of Research Webinar

adminOctober 28, 2024

October 16th 2024 Podcast Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with…

Oral Semaglutide Lowers Cardiovascular Events by 14% in Type 2 Diabetes Patients with Heart, Kidney Disease
Medicine

Oral Semaglutide Lowers Cardiovascular Events by 14% in Type 2 Diabetes Patients with Heart, Kidney Disease

adminOctober 27, 2024October 27, 2024

Credit: santoelia | stock.adobe.com Headline data from the Phase III SOUL trial found that oral semaglutide (Rybelsus) lowered major adverse…

Improving Site-Sponsor Collaboration in Clinical Trial Startup
Medicine

Improving Site-Sponsor Collaboration in Clinical Trial Startup

adminOctober 27, 2024

Christine Senn, Vice President, Site/Sponsor Innovation, Advarra Clinical research is more complicated and expensive than ever. That means the journey…

Uncertainty With Artificial Intelligence at the Site-Level
Medicine

Uncertainty With Artificial Intelligence at the Site-Level

adminOctober 26, 2024October 26, 2024

In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives…

4 Key Themes From Industry Conferences in 2024
Medicine

4 Key Themes From Industry Conferences in 2024

adminOctober 26, 2024

Conferences offer the clinical research industry a fantastic opportunity to meet face-to-face. Between friendly conversations and interactive sessions, key leaders…

Ebglyss Shows Significant Improvement in Skin Symptoms, Itch for Moderate-to-Severe Atopic Dermatitis
Medicine

Ebglyss Shows Significant Improvement in Skin Symptoms, Itch for Moderate-to-Severe Atopic Dermatitis

adminOctober 25, 2024October 25, 2024

Credit: ltyuan | stock.adobe.com Ebglyss (lebrikizumab-lbkz) was found to significantly improve skin symptoms and decrease itching in patients with moderate-to-severe atopic…

4 Challenges With Technology in Clinical Trials
Medicine

4 Challenges With Technology in Clinical Trials

adminOctober 25, 2024

The shift towards technology and other decentralized approaches in clinical trials has been occurring for years now. The promise of…

RSV Vaccine Arexvy Shows Potential for Expanded Use in At-Risk Adults Aged 18-49, Including Immunocompromised
Medicine

RSV Vaccine Arexvy Shows Potential for Expanded Use in At-Risk Adults Aged 18-49, Including Immunocompromised

adminOctober 24, 2024October 24, 2024

Credit: Julia | stock.adobe.com A pair of clinical trials demonstrated that GSK’s respiratory syncytial virus (RSV) vaccine Arexvy produced a…

4 Areas of Interest for Artificial Intelligence in Clinical Research
Medicine

4 Areas of Interest for Artificial Intelligence in Clinical Research

adminOctober 24, 2024

In recent years, the artificial intelligence (AI)-hype train has picked up steam. Its promise has caught the attention of countless…

Prioritizing Data Quality Amidst Complexity in Clinical Trials
Medicine

Prioritizing Data Quality Amidst Complexity in Clinical Trials

adminOctober 23, 2024

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in…

Re-imagining the Labs
Medicine

Re-imagining the Labs

adminOctober 23, 2024

Pharmaceutical companies face numerous drug development challenges today, including low drug approval rates, rising drug discovery costs, pressure to accelerate…

Vabysmo Shows Significant Vision Improvement for Diabetic Macular Edema in Underrepresented Patients
Medicine

Vabysmo Shows Significant Vision Improvement for Diabetic Macular Edema in Underrepresented Patients

adminOctober 22, 2024October 22, 2024

Credit: Dr_Microbe | stock.adobe.com One year of treatment with Vabysmo (faricimab-svoa) for diabetic macular edema (DME) produced significantly improved vision among…

4 Perspectives on FDA’s Diversity Action Plan Guidance
Medicine

4 Perspectives on FDA’s Diversity Action Plan Guidance

adminOctober 22, 2024October 22, 2024

In June, the FDA released its Diversity Action Plan guidance. The document outlines requirements for sponsors on submitting diversity plans…

Novel Once-Weekly HIV Treatment with Islatravir and Lenacapavir Shows Promising 94% Viral Suppression at 48 Weeks
Medicine

Novel Once-Weekly HIV Treatment with Islatravir and Lenacapavir Shows Promising 94% Viral Suppression at 48 Weeks

adminOctober 21, 2024October 21, 2024

Credit: artegorov3@gmail | stock.adobe.com The novel combination of islatravir (Merck) and lenacapavir (Gilead) maintained high rates of viral suppression in…

New Trends and Tactics in Outsourcing
Medicine

New Trends and Tactics in Outsourcing

adminOctober 21, 2024October 21, 2024

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Within the push for greater diversity of patient populations in clinical…

Driving Diversity with the Integrated Research Model
Medicine

Driving Diversity with the Integrated Research Model

adminOctober 20, 2024

Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses: Current trends and challenges with achieving greater diversity in…

How Digital Health Technologies are Addressing Unmet Measurement Needs in Parkinson’s Disease
Medicine

How Digital Health Technologies are Addressing Unmet Measurement Needs in Parkinson’s Disease

adminOctober 20, 2024

Image Credit: © Pixel-Shot – stock.adobe.com Clinical development in Parkinson’s disease (PD) faces numerous challenges and pitfalls. There is an…

AI Already Starting to Deliver Faster, Safer, More Effective Clinical Trials
Medicine

AI Already Starting to Deliver Faster, Safer, More Effective Clinical Trials

adminOctober 19, 2024

Credit: Shuo | stock.adobe.com Artificial intelligence (AI) has had an undeniable impact on society in the past few years, having…

Navigating the Complexities of Patient Data in Clinical Trials
Medicine

Navigating the Complexities of Patient Data in Clinical Trials

adminOctober 19, 2024October 19, 2024

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in…

Clesrovimab Shows Significant Reduction in RSV Infections, Hospitalizations in Infants
Medicine

Clesrovimab Shows Significant Reduction in RSV Infections, Hospitalizations in Infants

adminOctober 18, 2024

Credit: kitsawet | stock.adobe.com The results of the Phase IIb/III MK-1654-004 trial (NCT04767373) show that clesrovimab (Merck) produced a significant…

The Need for Clinical Trial Awareness
Medicine

The Need for Clinical Trial Awareness

adminOctober 18, 2024

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in…

Opdivo Combination Shows Superior Survival, Fewer Adverse Effects in Advanced Hodgkin Lymphoma
Medicine

Opdivo Combination Shows Superior Survival, Fewer Adverse Effects in Advanced Hodgkin Lymphoma

adminOctober 17, 2024

Credit: Dzmitry | stock.adobe.com The combination of Opdivo (nivolumab) plus chemotherapy was found to significantly improve progression-free survival (PFS) with…

Tina Bowdish Highlights the Importance of Site-Sponsor Relationships
Medicine

Tina Bowdish Highlights the Importance of Site-Sponsor Relationships

adminOctober 17, 2024

ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us a little…

Real-World Data Show 99% Efficacy for Apretude in HIV Prevention with High Adherence, Reduced Stigma
Medicine

Real-World Data Show 99% Efficacy for Apretude in HIV Prevention with High Adherence, Reduced Stigma

adminOctober 16, 2024October 16, 2024

Credit: jarun011 | stock.adobe.com Real-world data demonstrated that Apretude (cabotegravir long-acting [CAB-LA]; ViiV Healthcare) for HIV pre-exposure prophylaxis (PrEP) produced…

Achieving Optimal Adoption of Risk-Based Quality Management
Medicine

Achieving Optimal Adoption of Risk-Based Quality Management

adminOctober 16, 2024October 16, 2024

Steve Young, Chief Scientific Officer, CluePoints For more than a decade, the FDA and European Medicines Agency have encouraged the…

Implementing a Gold Standard FSP Strategic Partnership
Medicine

Implementing a Gold Standard FSP Strategic Partnership

adminOctober 15, 2024October 15, 2024

Elisa Mansfield, Vice President, FSP, Phastar The drug development landscape is continuously evolving. This evolution is ushering in a new…

The Strategic Emergence of Site Networks in Clinical Research
Medicine

The Strategic Emergence of Site Networks in Clinical Research

adminOctober 15, 2024

Gerri Gallagher, Head, US Site Engagement, GSK Adam Kinsey, Associate VP, Clinical Operations and Regional Head, North America, Merck Mark…

How the ‘Planning Fallacy’ Undermines Trial Success
Medicine

How the ‘Planning Fallacy’ Undermines Trial Success

adminOctober 14, 2024

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. In clinical research, the stakes are high, and…

Ensuring Greater Access and Diverse Patient Populations
Medicine

Ensuring Greater Access and Diverse Patient Populations

adminOctober 14, 2024October 14, 2024

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the…

A New Approach to Global Participant Payments
Medicine

A New Approach to Global Participant Payments

adminOctober 13, 2024

Discover how to handle participant payments in global studies with ease. Join us to learn practical tips and new strategies…

Elevating Patient Centricity in Clinical Trials
Medicine

Elevating Patient Centricity in Clinical Trials

adminOctober 13, 2024

Join experts from IQVIA Biotech and IQVIA in a webinar focused on enhancing clinical trial conduct by prioritizing patient-centric approaches.…

Tremfya Shows Superior Endoscopic Remission Rates in Crohn Disease, Ulcerative Colitis
Medicine

Tremfya Shows Superior Endoscopic Remission Rates in Crohn Disease, Ulcerative Colitis

adminOctober 12, 2024

Credit: luchschenF | stock.adobe.com Pooled data from the Phase III GALAXI trial (NCT03466411) and the Phase III QUASAR maintenance trial…

Understanding Acceptability of eConsent from a Global, Ethical, and Industry Perspective
Medicine

Understanding Acceptability of eConsent from a Global, Ethical, and Industry Perspective

adminOctober 12, 2024

To date, there is limited insight into the perspectives on eConsent in clinical trials of Independent Ethics Committees/Institutional Review Boards,…

Planning Ahead for FDA’s Multiregional Clinical Trials Guidance
Medicine

Planning Ahead for FDA’s Multiregional Clinical Trials Guidance

adminOctober 11, 2024

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the…

New Phase III Data of RSV Vaccine Arexvy Shows Efficacy Through Three Full Seasons
Medicine

New Phase III Data of RSV Vaccine Arexvy Shows Efficacy Through Three Full Seasons

adminOctober 11, 2024

Image Credit: © Aerial Mike – stock.adobe.com GSK has shared positive Phase III data from its AReSVi-006 trial of Arexvy,…

Industry Perspectives on the Key Challenges in Trial Optimization
Medicine

Industry Perspectives on the Key Challenges in Trial Optimization

adminOctober 10, 2024

The holy trinity of trial optimization At the core of trial optimization lies what the authors call the “holy trinity”…

Mwango Kashoki of Parexel Shares Initial Reaction to FDA Guidance on Conducting Multiregional Clinical Trials in Oncology
Medicine

Mwango Kashoki of Parexel Shares Initial Reaction to FDA Guidance on Conducting Multiregional Clinical Trials in Oncology

adminOctober 10, 2024

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the…

Keytruda Significantly Improves Event-Free Survival in Phase III Trial for Resected Head and Neck Cancer
Medicine

Keytruda Significantly Improves Event-Free Survival in Phase III Trial for Resected Head and Neck Cancer

adminOctober 9, 2024

Credit: Lars Neumann | stock.adobe.com Keytruda (pembrolizumab) produced a significant improvement in event-free survival (EFS) and major pathological response as a…

Trial Site Engagement Models are Poised for Disruption
Medicine

Trial Site Engagement Models are Poised for Disruption

adminOctober 9, 2024

Image Credit: © Egor – stock.adobe.com We’re witnessing significant changes in how trial sites interact with biopharmaceutical organizations.The adoption of…

Regulatory Outlook on Data Management
Medicine

Regulatory Outlook on Data Management

adminOctober 8, 2024

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and…

NIH Selects T Cell-Priming Vaccine Candidate to be Included in Clinical Trials Under Project NextGen
Medicine

NIH Selects T Cell-Priming Vaccine Candidate to be Included in Clinical Trials Under Project NextGen

adminOctober 8, 2024October 8, 2024

Image Credit: © Production Perig – stock.adobe.com Emergex Vaccines has announced that the National Institute of Allergy and Infectious Diseases…

Ziresovir Significantly Improves RSV Outcomes in Infants and Children, Reducing Viral Load and Symptoms in Phase 3 AIRFLO Trial
Medicine

Ziresovir Significantly Improves RSV Outcomes in Infants and Children, Reducing Viral Load and Symptoms in Phase 3 AIRFLO Trial

adminOctober 7, 2024

Credit: kitsawet | stock.adobe.com Ziresovir produced significantly greater clinical improvement, decreased viral load, and reduced the Wang bronchiolitis clinical score…

Evolving With Your Needs Now and in the Future
Medicine

Evolving With Your Needs Now and in the Future

adminOctober 6, 2024

• A one-size-fits-all model no longer exists. Because of this, Parexel’s models are flexible and agile, designed to adapt to…

FSP Partnership: A Foundation for Innovation and Patient-Guided Development
Medicine

FSP Partnership: A Foundation for Innovation and Patient-Guided Development

adminOctober 6, 2024October 6, 2024

Liz Rogers, VP and Head of Global Site and Study Operations at Pfizer, discusses Pfizer’s partnership with Parexel and transition…

Pomalidomide Significantly Reduces Bleeding, Improves Quality of Life in Hereditary Hemorrhagic Telangiectasia
Medicine

Pomalidomide Significantly Reduces Bleeding, Improves Quality of Life in Hereditary Hemorrhagic Telangiectasia

adminOctober 5, 2024October 5, 2024

Credit: luchschenF | stock.adobe.com Findings from the Phase II PATH-HHT trial (NCT03910244) show that pomalidomide significantly lowered the Epistaxis Severity…

Blending Models for Better Sourcing Solutions
Medicine

Blending Models for Better Sourcing Solutions

adminOctober 5, 2024

Tony Southers, Executive Vice President, Head of ICON Strategic Solutions In the new age of sourcing, sponsors are looking beyond the…

Ensuring Proper Data Collection
Medicine

Ensuring Proper Data Collection

adminOctober 4, 2024

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and…

Arcus and AstraZeneca Enter Collaboration for Clinical Trial in Renal Cell Carcinoma
Medicine

Arcus and AstraZeneca Enter Collaboration for Clinical Trial in Renal Cell Carcinoma

adminOctober 4, 2024

Image Credit: © Crystal light – stock.adobe.com Arcus Biosciences has announced a clinical trial collaboration agreement with AstraZeneca to evaluate…

Regulatory Challenges With Data Collection
Medicine

Regulatory Challenges With Data Collection

adminOctober 3, 2024October 3, 2024

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and…

New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients
Medicine

New Survey Uncovers Distrust as Key Factor in Enrollment Declines Among Black Patients

adminOctober 3, 2024

Image Credit: © Andrii Yalanskyi – stock.adobe.com Results from a survey conducted by two Baltimore medical centers suggest spiritual beliefs…

Complexities in Data Collection
Medicine

Complexities in Data Collection

adminOctober 2, 2024

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and…

Moving Beyond Claims Data in Clinical Trials
Medicine

Moving Beyond Claims Data in Clinical Trials

adminOctober 2, 2024

Image Credit: © ipopba – stock.adobe.com The pharmaceutical industry is facing a challenging landscape where the cost of bringing new…

Driving Point-of-care Decisions With RWE
Medicine

Driving Point-of-care Decisions With RWE

adminOctober 1, 2024

ACT: Looking forward, how will real-world evidence (RWE) drive point-of-care decisions? Gliklich: I love this question because one of the…

Cancer Clinical Research Sees Shift Toward Industry-Sponsored Trials
Medicine

Cancer Clinical Research Sees Shift Toward Industry-Sponsored Trials

adminOctober 1, 2024October 1, 2024

Image Credit: © FlowStudio – stock.adobe.com Cancer incidence in the United States is on the rise. According to the American…

The Potential of AI in Data Collection
Medicine

The Potential of AI in Data Collection

adminSeptember 30, 2024September 30, 2024

ACT: Is there any potential for the use of artificial intelligence (AI) in the data collection space? Gliklich: I love…

Bristol Myers Squibb and 2seventy bio Halt KarMMa-9 Trial in Patients with Newly Diagnosed Multiple Myeloma
Medicine

Bristol Myers Squibb and 2seventy bio Halt KarMMa-9 Trial in Patients with Newly Diagnosed Multiple Myeloma

adminSeptember 30, 2024

Credit: Saiful52 | stock.adobe.com Bristol Myers Squibb (BMS) and 2seventy bio announced the discontinuation of enrollment in the Phase III…

Reducing Burden With RWD
Medicine

Reducing Burden With RWD

adminSeptember 29, 2024

ACT: How can the integration of real-world data (RWD) reduce burden for key stakeholders in a trial such as sites,…

A Site Roadmap for Sponsors and CROs
Medicine

A Site Roadmap for Sponsors and CROs

adminSeptember 29, 2024September 29, 2024

This webinar, hosted by Avacare Clinical Research Network, will provide a comprehensive understanding of why clinical trial diversity matters and…

Regulatory Concerns Associated With Utilizing RWD
Medicine

Regulatory Concerns Associated With Utilizing RWD

adminSeptember 28, 2024September 28, 2024

ACT: What are some key regulatory requirements or challenges that need to be addressed when using real-world data (RWD)? Gliklich:…

Gazyva/Gazyvaro Shows Improved Complete Renal Response Among Patients with Lupus Nephritis
Medicine

Gazyva/Gazyvaro Shows Improved Complete Renal Response Among Patients with Lupus Nephritis

adminSeptember 28, 2024September 28, 2024

Credit: GoodIdeas | stock.adobe.com Findings from the Phase III REGENCY trial (NCT04221477) demonstrated that Gazyva/Gazyvaro (obinutuzumab; Roche) in combination with…

Advancing Safeguards for Innovative Clinical Research
Medicine

Advancing Safeguards for Innovative Clinical Research

adminSeptember 27, 2024September 27, 2024

Image Credit: © NicoElNino – stock.adobe.com As the field of clinical research undergoes rapid evolution, so too must the methodologies…

Medidata Launches New Patient Payment Solution
Medicine

Medidata Launches New Patient Payment Solution

adminSeptember 27, 2024

Image Credit: © Blue Planet Studio – stock.adobe.com Medidata has announced the launch of its newest solution, Patient Payments. Headlined…

Long-Term Extension Trial Shows Ebglyss Maintains Skin Clearance in Over 80% of Moderate-to-Severe Atopic Dermatitis Patients
Medicine

Long-Term Extension Trial Shows Ebglyss Maintains Skin Clearance in Over 80% of Moderate-to-Severe Atopic Dermatitis Patients

adminSeptember 26, 2024

Results from the ADjoin long-term extension study (NCT04392154) show that more than 80% of patients with moderate-to-severe atopic dermatitis (AD)…

Racial Disparities in Late-Stage Cancer Diagnosis for Adolescents and Young Adults
Medicine

Racial Disparities in Late-Stage Cancer Diagnosis for Adolescents and Young Adults

adminSeptember 26, 2024

Image Credit: © Jakub Krechowicz – stock.adobe.com While cancer affects all demographics, there is a noticeable difference in burden within…

IDEAYA Shares Positive Phase II Data for Darovasertib and Plans for Future Phase III Trial
Medicine

IDEAYA Shares Positive Phase II Data for Darovasertib and Plans for Future Phase III Trial

adminSeptember 25, 2024September 25, 2024

Image Credit: © Christoph Burgstedt – stock.adobe.com IDEAYA Biosciences has shared positive interim Phase II data for darovasertib in neoadjuvant…

The Importance of RWD in Rare Disease Research
Medicine

The Importance of RWD in Rare Disease Research

adminSeptember 25, 2024

ACT: How important is the role of real-world data (RWD) in clinical research for cancer and other rare diseases? Gliklich:…

Phase II AGAVE-201 Trial Shows Efficacy of Niktimvo for Refractory Chronic GVHD
Medicine

Phase II AGAVE-201 Trial Shows Efficacy of Niktimvo for Refractory Chronic GVHD

adminSeptember 24, 2024

Credit: gpointstudio | stock.adobe.com Results from the Phase II AGAVE-201 trial (NCT04710576) show that (Niktimvo) axatilimab monotherapy is effective and…

Developing AI/ML Models for Clinical Trials
Medicine

Developing AI/ML Models for Clinical Trials

adminSeptember 24, 2024

ACT: You have an upcoming session on “Transforming Clinical Trials: From Reactive to Predictive.” What are some of the main…

The Use of Artificial Intelligence in Clinical Trial Enrollment
Medicine

The Use of Artificial Intelligence in Clinical Trial Enrollment

adminSeptember 23, 2024

ACT: Is there any potential for the use of AI when it comes to decision-making and enrollment? Lwoff: In the…

Problem Solving in the Clinical Trial Realm
Medicine

Problem Solving in the Clinical Trial Realm

adminSeptember 23, 2024September 23, 2024

DPHARM’s “Aligning Innovations to Solve the Big Problems in Clinical Trials in a Resource-Constrained Environment” session When it comes to…

The Benefit to Adapting Operating Models
Medicine

The Benefit to Adapting Operating Models

adminSeptember 22, 2024

DPHARM’s “How Pharma is Shifting Operating Models for More Efficient Clinical Trials” session Sometimes, the innovation in things is to…

Imfinzi Treatment Regimen Shows Promise for Muscle-Invasive Bladder Cancer
Medicine

Imfinzi Treatment Regimen Shows Promise for Muscle-Invasive Bladder Cancer

adminSeptember 22, 2024September 22, 2024

Image credit: freshidea | stock.adobe.com Findings from the Phase III NIAGARA trial (NCT03732677) show that Imfinzi (durvalumab) in combination with…

Cabozantinib Shows Significant Progression-Free Survival Benefits in Phase III Trial for Advanced Neuroendocrine Tumors
Medicine

Cabozantinib Shows Significant Progression-Free Survival Benefits in Phase III Trial for Advanced Neuroendocrine Tumors

adminSeptember 21, 2024September 21, 2024

Image credit: THITIPORN | stock.adobe.com Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq) produced a…

Insights on the FDA’s Project Optimus and Dose Optimization
Medicine

Insights on the FDA’s Project Optimus and Dose Optimization

adminSeptember 21, 2024

Matt Cooper, PhD is an Executive Director and Therapeutic Strategy Lead, Oncology, at Worldwide Clinical Trials Jim Eamma is an…

AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment
Medicine

AutoCruitment CEO Jill Pellegrino Discusses Patient Recruitment

adminSeptember 20, 2024

ACT: You hosted a session on how to “Unlock the Power of the Patient for Better Patient Recruitment Outcomes.” What…

DPHARM 2024: eSource EHR Requirements
Medicine

DPHARM 2024: eSource EHR Requirements

adminSeptember 20, 2024

DPHARM’s “How Do You Make Scaling eSource EHR a Reality?” session Along its “New Approaches to Scale eSource EHR and…

Aligning Decisions with Clinical Trial Timelines
Medicine

Aligning Decisions with Clinical Trial Timelines

adminSeptember 19, 2024

ACT: What are some key considerations sponsors should be mindful of when aligning their decision-making process with the timeline of…

Acclinate CEO Del Smith Highlights the Roles of Technology and Engagement in Clinical Research
Medicine

Acclinate CEO Del Smith Highlights the Roles of Technology and Engagement in Clinical Research

adminSeptember 19, 2024September 19, 2024

ACT: You have an upcoming session on “Harnessing AI/ML to Drive Sustained Community Engagement for Diverse Clinical Trial Participation.” What…

DPHARM 2024: Improving Patient Recruitment Outcomes
Medicine

DPHARM 2024: Improving Patient Recruitment Outcomes

adminSeptember 18, 2024

DPHARM’s “Unlock the Power of the Patient for Better Patient Recruitment Outcomes” session The first day of DPHARM in Philadelphia…

DPHARM 2024: Analyzing DCT Deployments
Medicine

DPHARM 2024: Analyzing DCT Deployments

adminSeptember 18, 2024September 18, 2024

DPHARM’s “Examining Short and Long-Term ROI of DCT Deployment” session One of the first presentations to kick off DPHARM 2024…

Ponsegromab Significantly Improves Body Weight in Patients with Cancer Cachexia
Medicine

Ponsegromab Significantly Improves Body Weight in Patients with Cancer Cachexia

adminSeptember 17, 2024

Image Credit: Adobe Stock Images/penyushkin Data from Pfizer’s Phase II study of ponsegromab found that the treatment significantly improved body…

The Importance of Relationships Between CROs and Clinical Trial Sites
Medicine

The Importance of Relationships Between CROs and Clinical Trial Sites

adminSeptember 17, 2024

ACT: How important is it for CROs to form strong relationships with sites, especially in the rare disease space? Lwoff:…

Regulatory CMC: Enhancing Biologics Development
Medicine

Regulatory CMC: Enhancing Biologics Development

adminSeptember 16, 2024

Gabriel Bohl, PharmD, FTOPRA, Director, Regulatory Affairs, ICON plc In the rapidly evolving field of biologics, strategic chemistry, manufacturing, and…

AI Adoption for Clinical Trial Design, Planning
Medicine

AI Adoption for Clinical Trial Design, Planning

adminSeptember 16, 2024

Image credit: Tierney | stock.adobe.com Human-centered artificial intelligence (AI), which emphasizes harmoniously integrating technology and predictive analyses with a human…

Imfinzi Shows Significant Survival Benefits in Limited-Stage Small-Cell Lung Cancer in Phase III ADRIATIC Trial
Medicine

Imfinzi Shows Significant Survival Benefits in Limited-Stage Small-Cell Lung Cancer in Phase III ADRIATIC Trial

adminSeptember 15, 2024September 15, 2024

Image credit: Dr_Microbe | stock.adobe.com Results from the first planned interim analysis of the Phase III ADRIATIC trial (NCT03703297) show…

Aligning Technology and Oversight
Medicine

Aligning Technology and Oversight

adminSeptember 15, 2024September 15, 2024

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Throughout 2024, we have witnessed a multitude of advancements in the…

Applied Clinical Trials September 2024 Issue (PDF)
Medicine

Applied Clinical Trials September 2024 Issue (PDF)

adminSeptember 14, 2024

Applied Clinical Trials September 2024 Issue (PDF) Aligning Technology and Oversight A New Regulatory Road in Clinical Trials: Digital Twins…

Navigating The New EU Clinical Trial Framework
Medicine

Navigating The New EU Clinical Trial Framework

adminSeptember 14, 2024

ACT: As the deadline for legal transition for EU clinical trials approaches, what strategies can companies deploy to smoothly navigate…

A New Regulatory Road in Clinical Trials: Digital Twins
Medicine

A New Regulatory Road in Clinical Trials: Digital Twins

adminSeptember 13, 2024September 13, 2024

Gen Li, PhD, MBA, CEO and Founder, Phesi In recent decades, the complexity of clinical development has grown considerably. One…

Impactful EU Clinical Trial Regulation Changes
Medicine

Impactful EU Clinical Trial Regulation Changes

adminSeptember 13, 2024

ACT: What are the most impactful changes that companies need to be aware of? Neuberger: It was a different regulatory…

What Does it Aim to Achieve?
Medicine

What Does it Aim to Achieve?

adminSeptember 12, 2024

ACT: What does the EU’s clinical trial regulation aim to achieve? Neuberger: That is an important part. Why are we…

Bridging Patient Support Gaps While Navigating Global Regulations
Medicine

Bridging Patient Support Gaps While Navigating Global Regulations

adminSeptember 12, 2024

Craig Popovich, Associate Director, Implementation CIPP/E, Greenphire Solving site and sponsor clinical trial pain points with technology is hardly a…

2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliviera
Medicine

2024 Veeva R&D and Quality Summit: Q&A with Dee DeOliviera

adminSeptember 11, 2024

Dee DeOliviera, senior director, global regulatory operations, Cerevel (now part of AbbVie) The evolving regulatory landscape in clinical research was…

Top Takeaways from FDA Final Guidance on Real-World Evidence
Medicine

Top Takeaways from FDA Final Guidance on Real-World Evidence

adminSeptember 11, 2024

Image Credit: © Supapeach – stock.adobe.com The FDA’s latest guidance on how trial sponsors should use real-world evidence (RWE) in…

Driving Inclusion in Clinical Trials: Less Talk, More Trust
Medicine

Driving Inclusion in Clinical Trials: Less Talk, More Trust

adminSeptember 10, 2024

Gadi Saarony, CEO, Advarra Stripped down to its fundamentals, drug development requires diverse participant representation for safe and effective treatments.…

Bree Burks of Veeva Discusses Site-Sponsor Relationships
Medicine

Bree Burks of Veeva Discusses Site-Sponsor Relationships

adminSeptember 10, 2024

ACT: To get started, could you give us an overview of your focus area at Veeva? Burks: I have the…

Empowering Sponsors to Drive Trial Success
Medicine

Empowering Sponsors to Drive Trial Success

adminSeptember 9, 2024

Attend this new, interactive webinar and join experts who reveal how sponsors can leverage technology to drive study efficiency. Learn…

How Pharma is Tackling DE&I in the Workplace
Medicine

How Pharma is Tackling DE&I in the Workplace

adminSeptember 9, 2024

Katsuyoshi Sugita, chief people officer and chief ethics & compliance officer at Astellas Pharma. Katsuyoshi Sugita, the chief people officer…

Edoxaban Monotherapy Outperforms Dual Antithrombotic Therapy for Atrial Fibrillation, Stable Coronary Artery Disease
Medicine

Edoxaban Monotherapy Outperforms Dual Antithrombotic Therapy for Atrial Fibrillation, Stable Coronary Artery Disease

adminSeptember 8, 2024

Image credit: magicmine | stock.adobe.com Trial results show that edoxaban monotherapy reduced the risk of the primary net clinical outcome…

Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days
Medicine

Novel Agent Shows Superiority Over Placebo in Reducing Monthly Migraine Days

adminSeptember 8, 2024

Image credit: Damir Khabirov | stock.adobe.com A single intravenous (IV) infusion of Lundbeck’s investigational agent Lu AG09222 achieved superiority over…

Real-World Data Show Efficacy of PCSK9 Inhibitors in Lowering LDL-C in HeFH Patients with Statin Intolerance
Medicine

Real-World Data Show Efficacy of PCSK9 Inhibitors in Lowering LDL-C in HeFH Patients with Statin Intolerance

adminSeptember 7, 2024

Image credit: Rasi | stock.adobe.com Real world data demonstrated the efficacy of PCSK9 inhibitors in reducing low-density lipoprotein (LDL-C) cholesterol…

Eli Lilly’s Insulin Efsitora Alfa Succeeds in Duo of Type 2 Diabetes Phase III Studies
Medicine

Eli Lilly’s Insulin Efsitora Alfa Succeeds in Duo of Type 2 Diabetes Phase III Studies

adminSeptember 7, 2024

Image Credit: © Minerva Studio – stock.adobe.com Eli Lilly has shared positive study data from its QWINT clinical trial program…

Veeva Adds New Capabilities to Veeva Site Connect
Medicine

Veeva Adds New Capabilities to Veeva Site Connect

adminSeptember 6, 2024

Image Credit: © NicoElNino – stock.adobe.com Veeva Systems has announced the newest release of Veeva Site Connect. New capabilities of…

Gaps and Opportunities in Qualitative Systematic Reviews
Medicine

Gaps and Opportunities in Qualitative Systematic Reviews

adminSeptember 6, 2024

Image Credit: Adobe Stock Images/Generative AI In the past few years, there has been more of a focus on equity,…

Medidata and Aixial Group Partner to Achieve Streamlined Database Lock
Medicine

Medidata and Aixial Group Partner to Achieve Streamlined Database Lock

adminSeptember 5, 2024September 5, 2024

Image Credit: © nespix – stock.adobe.com Medidata and Aixial Group have announced a new partnership to streamline clinical trial execution…

Take Control of Site Costs with Clinical Research Terminology Codes
Medicine

Take Control of Site Costs with Clinical Research Terminology Codes

adminSeptember 5, 2024

Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards Initiative (CRISI)…

Plozasiran Reduces Triglycerides, Pancreatitis Risk in Persistent Chylomicronemia
Medicine

Plozasiran Reduces Triglycerides, Pancreatitis Risk in Persistent Chylomicronemia

adminSeptember 4, 2024

Image credit: alexlmx | stock.adobe.com Data from the Phase III PALISADE trial (NCT05089084) demonstrated that plozasiran (Arrowhead) significantly reduced triglyceride…

Lyme Disease Vaccine Candidate Continues to Show Strong Immune Response Following Second Booster Dose
Medicine

Lyme Disease Vaccine Candidate Continues to Show Strong Immune Response Following Second Booster Dose

adminSeptember 4, 2024September 4, 2024

Image Credit: © fotovapl – stock.adobe.com Valneva and Pfizer have shared positive Phase II results from their study of VLA15,…

The Potential of AI in Budgeting and Forecasting
Medicine

The Potential of AI in Budgeting and Forecasting

adminSeptember 3, 2024

ACT: Is there any potential for the use of artificial intelligence (AI) in budgeting and forecasting? If so, how? Murphy:…

5 essential capabilities for decentralized clinical trials (DCT)
Medicine

5 essential capabilities for decentralized clinical trials (DCT)

adminSeptember 3, 2024

July 30th 2024 Article Do you leverage a quality-first mindset as you evaluate clinical trial technology? When you evaluate eCOA…

Johnson & Johnson Seeks FDA Approval for Nipocalimab in Generalized Myasthenia Gravis
Medicine

Johnson & Johnson Seeks FDA Approval for Nipocalimab in Generalized Myasthenia Gravis

adminSeptember 2, 2024

Image Credit: Adobe Stock Images/Lila Patel Johnson & Johnson has announced the submission of a Biologics License Application (BLA) to…

Four Hundred Scientists Share Secrets to Maximizing R&D Data
Medicine

Four Hundred Scientists Share Secrets to Maximizing R&D Data

adminSeptember 2, 2024

Image credit: Molnia | stock.adobe.com Data is more important than ever in today’s challenging R&D environment, but as most lab…

Current Trends in Patient Reimbursement
Medicine

Current Trends in Patient Reimbursement

adminSeptember 1, 2024

ACT: What are some trends that you’re currently seeing with patient reimbursement? I mentioned the cost of travel reimbursement, those things…

DVCR is Designed Differently
Medicine

DVCR is Designed Differently

adminSeptember 1, 2024

Zach Bader (Vice President, Business Development) talked with ACT about how Dr. Vince Clinical Research (DVCR) is challenging the status…

DVCR’s Multi-Site Model
Medicine

DVCR’s Multi-Site Model

adminAugust 31, 2024

Korey Nevitt (Executive Director, Site Partnerships) talked with ACT about what makes Dr. Vince Clinical Research (DVCR) solutions for clinical…

Olaparib Demonstrates Efficiency in Biochemically Recurrent Prostate Cancer
Medicine

Olaparib Demonstrates Efficiency in Biochemically Recurrent Prostate Cancer

adminAugust 31, 2024

Image Credit: Adobe Stock Images/Best Results from a recent Phase II clinical trial conducted by Johns Hopkins Kimmel Cancer Center…

Crinecerfont Found to Lower Androstenedione Levels in Pediatric Patients with Congenital Adrenal Hyperplasia
Medicine

Crinecerfont Found to Lower Androstenedione Levels in Pediatric Patients with Congenital Adrenal Hyperplasia

adminAugust 30, 2024

Image credit: growth.co | stock.adobe.com Findings from the Phase III CAHtalyst Pediatric Study (NCT04806451) show that crinecerfont (Neurocrine Biosciences) is…

Leqvio Achieves Statistically Significant LDL-C Lowering in Phase III Study
Medicine

Leqvio Achieves Statistically Significant LDL-C Lowering in Phase III Study

adminAugust 30, 2024

Image Credit: © Rasi – stock.adobe.com Novartis has shared positive results from its Phase III study of Leqvio (inclisiran) in…

FDA Accepts Protocols and Endpoints for Phase III Trial of PL9643 in Dry Eye Disease
Medicine

FDA Accepts Protocols and Endpoints for Phase III Trial of PL9643 in Dry Eye Disease

adminAugust 29, 2024

Image Credit: © Pixel-Shot – stock.adobe.com Palatin has announced receipt of FDA’s acceptance of protocols and endpoints for signs and…

The Impact of Patient Data Access
Medicine

The Impact of Patient Data Access

adminAugust 29, 2024

ACT: What impact does patient data access have on elements such as forecasting, budgeting, and enrollment? Murphy: Well, there are…

First Patient Dosed in Phase III Study of Fezolinetant for Hot Flashes in Women with Breast Cancer
Medicine

First Patient Dosed in Phase III Study of Fezolinetant for Hot Flashes in Women with Breast Cancer

adminAugust 28, 2024

Image Credit: © Crystal light – stock.adobe.com Astellas has announced the dosing of the first patient in its HIGHLIGHT 1…

Challenges with Budgeting and Analytics in Trials
Medicine

Challenges with Budgeting and Analytics in Trials

adminAugust 28, 2024August 28, 2024

ACT: What are some challenges that stakeholders are currently seeing with budgeting and analytics in their trials? Murphy: Well, the…

Pfizer and BioNTech Receive FDA Approval for Latest COVID-19 Vaccine
Medicine

Pfizer and BioNTech Receive FDA Approval for Latest COVID-19 Vaccine

adminAugust 27, 2024August 27, 2024

Image Credit: © Production Perig – stock.adobe.com The FDA has approved and granted emergency use authorization (EUA) for Pfizer and…

Identifying the Most Common Symptoms of Long COVID in Children and Adolescents
Medicine

Identifying the Most Common Symptoms of Long COVID in Children and Adolescents

adminAugust 27, 2024

Image Credit: © AntonioDiaz – stock.adobe.com While the height of the COVID-19 pandemic is well behind us, its effects have…

Tirzepatide Shows Substantial Decrease in Risk of Patients with Pre-Diabetes Developing Type 2 Diabetes
Medicine

Tirzepatide Shows Substantial Decrease in Risk of Patients with Pre-Diabetes Developing Type 2 Diabetes

adminAugust 26, 2024

Image credit: Minerva Studio | stock.adobe.com Weekly tirzepatide (Zepbound and Mounjaro; Eli Lilly) injections (5 mg, 10 mg, 15 mg) lowered…

Lumryz Associated with Weight Loss in Patients with Narcolepsy
Medicine

Lumryz Associated with Weight Loss in Patients with Narcolepsy

adminAugust 26, 2024

Image credit: Laflor/peopleimages.com | stock.adobe.com Findings from a post-hoc analysis of the pivotal Phase III REST-ON trial (NCT02720744) show that patients with…

Welireg Shows Survival Advantage Over Everolimus Treating Advanced Clear-Cell Renal Cell Carcinoma
Medicine

Welireg Shows Survival Advantage Over Everolimus Treating Advanced Clear-Cell Renal Cell Carcinoma

adminAugust 25, 2024August 25, 2024

Image credit: MdBabul | stock.adobe.com Welireg (belzutifan) produced a significant benefit compared to everolimus (Afintior; Afinitor Disperz; Zortress) in progression-free survival…

The Role of Collaboration in Achieving Greater Diversity in Clinical Research
Medicine

The Role of Collaboration in Achieving Greater Diversity in Clinical Research

adminAugust 25, 2024

ACT: What areas of trial design should stakeholders be focusing on the most to increase diversity within their studies? Moultrie:…

Study Shows Infusion of Amino Acids Reduces Risk of Acute Kidney Injury Following Cardiac Surgery
Medicine

Study Shows Infusion of Amino Acids Reduces Risk of Acute Kidney Injury Following Cardiac Surgery

adminAugust 24, 2024

Image credit: Crystal light | stock.adobe.com Findings from a Phase III trial (NCT03709264) show that intravenous (IV) infusion of amino…

FDA Clears IND for Phase I/II Study in Relapsed/Refractory Non-Hodgkin Lymphoma
Medicine

FDA Clears IND for Phase I/II Study in Relapsed/Refractory Non-Hodgkin Lymphoma

adminAugust 24, 2024

Image Credit: © Dr_Microbe – stock.adobe.com The FDA has cleared an Investigational New Drug (IND) application for an open-label, multicenter,…

Ashley Moultrie of Javara Shares Thoughts on FDA’s Diversity Action Plan Guidance
Medicine

Ashley Moultrie of Javara Shares Thoughts on FDA’s Diversity Action Plan Guidance

adminAugust 23, 2024August 23, 2024

ACT: What are your thoughts on the FDA’s recently released Diversity Action Plan Guidance? How will this affect sponsors moving…

Results from Phase III Duo Show Elinzanetant Significantly Reduced Frequency and Severity of Hot Flashes Associated with Menopause
Medicine

Results from Phase III Duo Show Elinzanetant Significantly Reduced Frequency and Severity of Hot Flashes Associated with Menopause

adminAugust 23, 2024

Image Credit: © ArtyKris99 – stock.adobe.com Full data for the duo of Phase III studies—OASIS 1 and 2—has been published…

Tufts CSDD Site Experience Survey
Medicine

Tufts CSDD Site Experience Survey

adminAugust 22, 2024

Image Credit: © Andrii Yalanskyi – stock.adobe.com Researchers at Tufts CSDD at the Tufts University School of Medicine, in collaboration…

Increasing Diversity with the Integrated Research Model
Medicine

Increasing Diversity with the Integrated Research Model

adminAugust 22, 2024August 22, 2024

ACT: What do you think are currently industry’s greatest obstacles in achieving more diversity in trials? Moultrie: I would say,…

Walgreens and BARDA Partner to Increase DCT Innovation
Medicine

Walgreens and BARDA Partner to Increase DCT Innovation

adminAugust 21, 2024

Image Credit: © peshkova – stock.adobe.com Walgreens and the Biomedical Advanced Research and Development Authority (BARDA) have announced a strategic…

FDA Approves Rybrevant Combination for Advanced Non-Small Cell Lung Cancer
Medicine

FDA Approves Rybrevant Combination for Advanced Non-Small Cell Lung Cancer

adminAugust 21, 2024

Image Credit: © iDoPixBox – stock.adobe.com The FDA has approved Johnson & Johnson’s Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the…

Applied Clinical Trials July/August 2024 Issue (PDF)
Medicine

Applied Clinical Trials July/August 2024 Issue (PDF)

adminAugust 20, 2024

Applied Clinical Trials July/August 2024 Issue (PDF) Streamlining Clinical Trials with eSource: Insights from MSK Decentralized Clinical Trials: Bust or…

Xtandi Shows Superior Survival Outcomes to Abiraterone in Treatment of Metastatic Castration-Resistant Prostate Cancer
Medicine

Xtandi Shows Superior Survival Outcomes to Abiraterone in Treatment of Metastatic Castration-Resistant Prostate Cancer

adminAugust 20, 2024

Image credit: Dr_Microbe | stock.adobe.com A retrospective, multicenter cohort study found that Xtandi (enzalutamide) achieved small but statistically significant improvements…

Reqorsa Demonstrates Promising Results in Treating Patients with Small Cell Lung Cancer and Non-Small Cell Lung Cancer
Medicine

Reqorsa Demonstrates Promising Results in Treating Patients with Small Cell Lung Cancer and Non-Small Cell Lung Cancer

adminAugust 19, 2024August 19, 2024

Image Credit: Adobe Stock Images/appledesign Results from the Acclaim study program found that Genprex’s Reqorsa (quaratusugene ozeplasmid) demonstrated promise in…

Choosing the Best Clinical Technology for Your Study
Medicine

Choosing the Best Clinical Technology for Your Study

adminAugust 19, 2024

What should be top of mind for stakeholders when they are deciding what clinical technology is best for their individual…

The Evolution of CRAACO: Gains and Lessons Learned
Medicine

The Evolution of CRAACO: Gains and Lessons Learned

adminAugust 18, 2024

Tracking efforts to advance the mission and concept of “clinical research as a care option.”

How Regulators are Viewing the Current Landscape of Clinical Technology
Medicine

How Regulators are Viewing the Current Landscape of Clinical Technology

adminAugust 18, 2024August 18, 2024

ACT: How are the regulators viewing this current “boom” in clinical technology? How has their stance on it changed over…

Pfizer and BioNTech’s mRNA-Based Combination Vaccine Demonstrates Strong Immune Responses to Influenza A
Medicine

Pfizer and BioNTech’s mRNA-Based Combination Vaccine Demonstrates Strong Immune Responses to Influenza A

adminAugust 17, 2024

Image Credit: Adobe Stock Images/arti om Pfizer and BioNTech announced that their mRNA-based combination vaccine program aimed at combating both…

Monjuvi Succeeds in Phase III Trial of Patients with Relapsed or Refractory Follicular Lymphoma
Medicine

Monjuvi Succeeds in Phase III Trial of Patients with Relapsed or Refractory Follicular Lymphoma

adminAugust 17, 2024

Image Credit: © Aerial Mike – stock.adobe.com Incyte has shared positive Phase III results of its CD19-targeting monoclonal antibody, Monjuvi…

FDA Grants Breakthrough Therapy Designation, Priority Review to AstraZeneca’s Imfinzi for the Treatment of Limited-Stage Small Cell Lung Cancer
Medicine

FDA Grants Breakthrough Therapy Designation, Priority Review to AstraZeneca’s Imfinzi for the Treatment of Limited-Stage Small Cell Lung Cancer

adminAugust 16, 2024August 16, 2024

Image Credit: Adobe Stock Images/pakbung The FDA has granted Breakthrough Therapy Designation and Priority Review to AstraZeneca’s Infimzi (durvalumab), indicated…

Decentralized Clinical Trials: Bust or Breakthrough?
Medicine

Decentralized Clinical Trials: Bust or Breakthrough?

adminAugust 16, 2024August 16, 2024

Decentralized clinical trials (DCTs) are shapeshifting. Originally piloted 15 years ago and more recently catalyzed by the COVID-19 pandemic, DCTs…

‘Fit-for-Purpose’ Considerations for Remote Trials
Medicine

‘Fit-for-Purpose’ Considerations for Remote Trials

adminAugust 15, 2024August 15, 2024

Joachim Lövin, Workstream Lead on Modernizing Clinical Trial Conduct, TransCelerate BioPharma Inc., and DCT Specialist, Novo Nordisk In the following…

Integrating Clinical Technology
Medicine

Integrating Clinical Technology

adminAugust 15, 2024

ACT: What are some challenges you are currently seeing with the integration of clinical technology? Easy: That is a huge…

Engaging Emerging Clinical Investigators Yields Unique Benefits for All
Medicine

Engaging Emerging Clinical Investigators Yields Unique Benefits for All

adminAugust 14, 2024August 14, 2024

Benjamin Marcum, MD, family practitioner, Stephenville Medical and Surgical Clinic, Privia Health Emerging investigators play a vital role in bringing…

Abrysvo Demonstrates Safety and Efficacy as an RSV Vaccine in Immunocompromised Adults
Medicine

Abrysvo Demonstrates Safety and Efficacy as an RSV Vaccine in Immunocompromised Adults

adminAugust 14, 2024

Image Credit: Adobe Stock Images/Mahmud Pfizer announced top-line results from the ongoing Phase III MONeT (RSV IMmunizatiON Study for AdulTs…

Reproxalap Significantly Reduces Ocular Discomfort in a Phase III Clincal Trial for the Treatment of Dry Eye Disease
Medicine

Reproxalap Significantly Reduces Ocular Discomfort in a Phase III Clincal Trial for the Treatment of Dry Eye Disease

adminAugust 13, 2024August 13, 2024

Image Credit: Adobe Stock Images/Media Srock Results from a Phase III clinical trial demonstrated that Aldeyra Therapeutics’ Reproxalap demonstrated a…

Utilizing the eConsent Fit-for-Purpose Study Framework
Medicine

Utilizing the eConsent Fit-for-Purpose Study Framework

adminAugust 13, 2024August 13, 2024

Image Credit: © photon_photo – stock.adobe.com To date, eConsent adoption and tangible study data about eConsent outcomes are limited. The…

Medicine

Current Challenges in Patient Centricity

adminAugust 12, 2024

ACT: What do you think are currently industry’s greatest challenges in patient centricity? Keunen: Patient centricity—that’s a big topic, indeed.…

Building Patient-centric Technology
Medicine

Building Patient-centric Technology

adminAugust 12, 2024August 12, 2024

ACT: What do technology vendors need to focus on most when creating patient-centric solutions? Keunen: It seems obvious, but ask…

Reducing Patient Dropout Rates and Accelerating Trial Completion
Medicine

Reducing Patient Dropout Rates and Accelerating Trial Completion

adminAugust 11, 2024

Jon Ernst talked with ACT about how PCM Trials are harmonizing various elements in the decentralized clinical trial process. Learn…

Identifying the Most Useful Features in Solutions from a Patient POV
Medicine

Identifying the Most Useful Features in Solutions from a Patient POV

adminAugust 11, 2024

ACT: As a patient yourself, what specific features or functions do you look for in technology? Keunen: I went through…

Delivering Operational Excellence in a Complex Environment of CAR-Directed Cell Therapies
Medicine

Delivering Operational Excellence in a Complex Environment of CAR-Directed Cell Therapies

adminAugust 10, 2024August 10, 2024

Vito Romita, PhD, MSc, Senior Director, Global Project Management, Hematology/Oncology Therapeutic Unit, PPD clinical research business, Thermo Fisher Scientific Introduction…

Sarclisa Combination Produces Significantly Improved Progression-Free Survival in Newly Diagnosed Multiple Myeloma
Medicine

Sarclisa Combination Produces Significantly Improved Progression-Free Survival in Newly Diagnosed Multiple Myeloma

adminAugust 10, 2024August 10, 2024

Image credit: Saiful52 | stock.adobe.com The results of a Phase III trial show that the combination of Sarclisa (isatuximab-irfc; Sanofi)…

Nipocalimab Shows Significant Promise Treating Early-Onset Severe Hemolytic Disease of the Fetus and Newborn
Medicine

Nipocalimab Shows Significant Promise Treating Early-Onset Severe Hemolytic Disease of the Fetus and Newborn

adminAugust 9, 2024

Image credit: adimas | stock.adobe.com Results from the Phase II UNITY trial demonstrated that nipocalimab delayed or stopped the development…

Merck Discontinues Phase III Trial of Keytruda Combination for SCLC
Medicine

Merck Discontinues Phase III Trial of Keytruda Combination for SCLC

adminAugust 9, 2024August 9, 2024

Image Credit: © iDoPixBox – stock.adobe.com Merck has announced the discontinuation of the Phase III KeyVibe-008 trial evaluating a fixed-dose…

Postsurgical Pain Candidate Vocacapsaicin Demonstrates Efficacy in Reducing Opioid Use
Medicine

Postsurgical Pain Candidate Vocacapsaicin Demonstrates Efficacy in Reducing Opioid Use

adminAugust 8, 2024

Image Credit: © Egor – stock.adobe.com Concentric Analgesics has shared positive Phase II data for its leading postsurgical pain management…

Addition of Olanzapine Improves Complete Response, Nausea and Vomiting Prevention in Chemotherapy-Naive Patients
Medicine

Addition of Olanzapine Improves Complete Response, Nausea and Vomiting Prevention in Chemotherapy-Naive Patients

adminAugust 7, 2024

Image credit: 9nong | stock.adobe.com A Phase III trial found that adding olanzapine to moderately emetogenic chemotherapy (MEC) regimens consisting…

Trial Results Show Efficacy of Extended Dosing Tremfya in Clearance of Psoriasis
Medicine

Trial Results Show Efficacy of Extended Dosing Tremfya in Clearance of Psoriasis

adminAugust 7, 2024

Image credit: fusssergei | stock.adobe.com Findings from the Phase IIIb GUIDE clinical trial (NCT03818035) show that after early and complete…

Kerendia Achieves Reduction in Risk of Cardiovascular Death and Heart Failure
Medicine

Kerendia Achieves Reduction in Risk of Cardiovascular Death and Heart Failure

adminAugust 6, 2024

Image Credit: © Africa Studio – stock.adobe.com Bayer has shared new data from the Phase III FINEARTS-HF clinical trial, showing…

Eli Lilly’s Tirzepatide Shows Reduction in Risk of Heart Failure Outcomes
Medicine

Eli Lilly’s Tirzepatide Shows Reduction in Risk of Heart Failure Outcomes

adminAugust 6, 2024

Image Credit: © ckybe – stock.adobe.com According to new data revealed by Eli Lilly, tirzepatide significantly improved heart failure symptoms…

Clinical Study Investigates ‘Obesity Paradox’ in Treatment of Non-Small Cell Lung Cancer
Medicine

Clinical Study Investigates ‘Obesity Paradox’ in Treatment of Non-Small Cell Lung Cancer

adminAugust 5, 2024

Image credit: Sebastian Kaulitzki | stock.adobe.com New clinical data published by JAMA Network Open indicates that immune checkpoint inhibitor (ICI)…

Oral Semaglutide Shows Improved Energy Intake, Appetite, Eating Control in Adults with Obesity
Medicine

Oral Semaglutide Shows Improved Energy Intake, Appetite, Eating Control in Adults with Obesity

adminAugust 5, 2024

Image credit: Peter Hansen | stock.adobe.com Findings from a double-blind study (NCT05236517) show that once-daily oral semaglutide at a dose…

Improving Trial Design with LLMs
Medicine

Improving Trial Design with LLMs

adminAugust 4, 2024

ACT: Specifically, how can these large language models (LLMs) improve trial design, recruitment, and analysis? Kondru: I want us to…

Strategies From Design to Delivery
Medicine

Strategies From Design to Delivery

adminAugust 4, 2024August 4, 2024

Join experts to explore regulatory strategies, clinical challenges, and operational models that speed up trials and bring patient treatments. Register…

Leveraging Real-World Evidence to Optimize Trial Design
Medicine

Leveraging Real-World Evidence to Optimize Trial Design

adminAugust 3, 2024August 3, 2024

ACT: Are there any opportunities for these AI models to leverage data such as real-world data (RWD)? If so, how?…

A New Tool for Optimizing Site Payments
Medicine

A New Tool for Optimizing Site Payments

adminAugust 3, 2024August 3, 2024

Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards Initiative (CRISI)…

Antihypertensive Treatment May Improve Target Organ Damage in Patients with Masked Hypertension
Medicine

Antihypertensive Treatment May Improve Target Organ Damage in Patients with Masked Hypertension

adminAugust 2, 2024

Image credit: grinny | stock.adobe.com Antihypertensive medications may improve target organ damage (TOD) in patients with masked hypertension compared to…

Blenrep Combo Shows Significant Survival Benefit Over Darzalex Combo in Patients with Relapsed or Refractory Multiple Myeloma
Medicine

Blenrep Combo Shows Significant Survival Benefit Over Darzalex Combo in Patients with Relapsed or Refractory Multiple Myeloma

adminAugust 2, 2024

Image credit: LASZLO | stock.adobe.com The combination of Blenrep (belantamab mafodotin), bortezomib, and dexamethasone (BVd) demonstrated a significant benefit in…

Emerging Phase II Data Show Evorpacept Improved Tumor Response in Patients with Gastric Cancer
Medicine

Emerging Phase II Data Show Evorpacept Improved Tumor Response in Patients with Gastric Cancer

adminAugust 1, 2024

Image Credit: © PIC4U – stock.adobe.com Evorpacept, a CD47 blocker, has returned positive data from the Phase II ASPEN-06 clinical…

PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy Demonstrates Higher Levels of Exon Skipping in Phase II Trial
Medicine

PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy Demonstrates Higher Levels of Exon Skipping in Phase II Trial

adminAugust 1, 2024

Image Credit: © Aerial Mike – stock.adobe.com PepGen has shared positive data from the CONNECT1-EDO51 Phase II trial (NCT06079736) of…

Current Uses of LLMs in Clinical Trials
Medicine

Current Uses of LLMs in Clinical Trials

adminJuly 31, 2024

ACT: What is the current state of the use of large language models (LLMs) in clinical trials? Kondru: I think…

Emerging Phase III Results Show CALQUENCE Regimen Significantly Improved Progression-free Survival in Leukemia Patients
Medicine

Emerging Phase III Results Show CALQUENCE Regimen Significantly Improved Progression-free Survival in Leukemia Patients

adminJuly 31, 2024July 31, 2024

Image Credit: © chayantorn – stock.adobe.com AstraZeneca has shared positive, interim results from the AMPLIFY Phase III trial (NCT03836261) evaluating…

You Are Forgetting the Patient, but You’re Not Alone
Medicine

You Are Forgetting the Patient, but You’re Not Alone

adminJuly 30, 2024

Vincent Keunen, founder and CEO of Andaman7 shares his thoughts on how industry can achieve true patient centricity through emerging…

Phase III BROOKLYN Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia Meets Primary Endpoint
Medicine

Phase III BROOKLYN Trial Evaluating Obicetrapib in Patients with Heterozygous Familial Hypercholesterolemia Meets Primary Endpoint

adminJuly 30, 2024

Image Credit: © photon_photo – stock.adobe.com NewAmsterdam Pharma has shared positive results from its pivotal Phase III BROOKLYN clinical trial…

Lomecel-B Meets Key Objectives in Phase IIa Alzheimer’s Study
Medicine

Lomecel-B Meets Key Objectives in Phase IIa Alzheimer’s Study

adminJuly 29, 2024

Image Credit: © LIGHTFIELD STUDIOS – stock.adobe.com Lomecel-B, a living cell product for the treatment of Alzheimer’s Disease, has met…

Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Head-to-Head Phase IV Trial
Medicine

Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Head-to-Head Phase IV Trial

adminJuly 29, 2024July 29, 2024

Image Credit: © Ezume Images – stock.adobe.com ViiV Healthcare has shared initial results from the 48-week Phase IV PASO DOBLE…

Themes Involving Clinical Trials at the 2024 DIA Global Annual Meeting
Medicine

Themes Involving Clinical Trials at the 2024 DIA Global Annual Meeting

adminJuly 28, 2024

ACT: When it comes to clinical trials specifically, what do you think some of the most relevant themes were at…

DIA’s Objectives for the Remainder of 2024
Medicine

DIA’s Objectives for the Remainder of 2024

adminJuly 28, 2024

ACT: What are your goals or objectives for DIA for the remainder of the year? Pierce: There are so many…

DIA’s Impact on the Clinical Research Industry
Medicine

DIA’s Impact on the Clinical Research Industry

adminJuly 27, 2024July 27, 2024

ACT: What kind of impact do you hope DIA and its conferences have within the clinical trials industry? Pierce: DIA…

Early-Phase Trial Indicates Potential of Fecal Microbiota Transplant in Overcoming Resistance to Immune Checkpoint Inhibitors
Medicine

Early-Phase Trial Indicates Potential of Fecal Microbiota Transplant in Overcoming Resistance to Immune Checkpoint Inhibitors

adminJuly 27, 2024

Image credit: drimafilm | stock.adobe.com An early-phase clinical trial (NCT04264975) suggests that patients with cancer who have shown prior resistance…

Undue Burden Created by Protocol Deviations
Medicine

Undue Burden Created by Protocol Deviations

adminJuly 26, 2024

Jim Wahl, vice president, client services, TruLab In the clinical trial ecosystem these days, patient-centricity has become quite the buzzword.…

Investigational Gene Therapy for Hemophilia A Shows Positive Results in Phase III Clinical Trial
Medicine

Investigational Gene Therapy for Hemophilia A Shows Positive Results in Phase III Clinical Trial

adminJuly 26, 2024

Image Credit: © Design Cells – stock.adobe.com Giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately…

Blincyto Plus Consolidation Chemotherapy Produces Significant Survival Improvement in MRD-Negative Acute Lymphoblastic Leukemia
Medicine

Blincyto Plus Consolidation Chemotherapy Produces Significant Survival Improvement in MRD-Negative Acute Lymphoblastic Leukemia

adminJuly 25, 2024

Image credit: MdBabul | stock.adobe.com Blincyto (blinatumomab; Amgen) added to consolidation chemotherapy produced a significant improvement in overall survival (OS)…

Topline Results from Phase IIb/Phase III Trial of Clesrovimab Show Reduction in Attended Lower Respiratory Infection in Infants
Medicine

Topline Results from Phase IIb/Phase III Trial of Clesrovimab Show Reduction in Attended Lower Respiratory Infection in Infants

adminJuly 25, 2024

Image Credit: © Gary – stock.adobe.com Clesrovimab (MK-1654), Merck’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial…

Pair of Randomized Clinical Trials Show Skyrizi Improves Clinical Remission in Moderately to Severely Active Ulcerative Colitis
Medicine

Pair of Randomized Clinical Trials Show Skyrizi Improves Clinical Remission in Moderately to Severely Active Ulcerative Colitis

adminJuly 24, 2024

Image credit: Sebastian Kaulitzki | stock.adobe.com An analysis of two randomized clinical trials (NCT03398148 and NCT03398135) found that Skyrizi (risankizumab;…

DIA Global Head of Growth Highlights Variety of Sessions at the 2024 Global Annual Meeting
Medicine

DIA Global Head of Growth Highlights Variety of Sessions at the 2024 Global Annual Meeting

adminJuly 24, 2024

ACT: What were your impressions of the sessions at DIA? Pierce: The sessions that I saw that were the most well…

Felzartamab Shows Potential Therapeutic Benefit, Acceptable Safety for Late Antibody-Mediated Rejection
Medicine

Felzartamab Shows Potential Therapeutic Benefit, Acceptable Safety for Late Antibody-Mediated Rejection

adminJuly 23, 2024July 23, 2024

Image credit: Crystal light | stock.adobe.com Felzartamab demonstrated a potential therapeutic benefit and an acceptable safety and adverse event (AE)…

DIA Global Head of Growth, Carie Pierce Discusses 2024 Global Annual Meeting
Medicine

DIA Global Head of Growth, Carie Pierce Discusses 2024 Global Annual Meeting

adminJuly 23, 2024

ACT: What were your greatest takeaways from this year’s DIA Global Annual Meeting in San Diego? Pierce: This was my…

Study Finds Oral Corticosteroid Use Over 90 Days Slightly Increases Adverse Event Risk in Adults with Atopic Dermatitis
Medicine

Study Finds Oral Corticosteroid Use Over 90 Days Slightly Increases Adverse Event Risk in Adults with Atopic Dermatitis

adminJuly 22, 2024

Image credit: sinhyu | stock.adobe.com A nested case-control study found that limiting the treatment duration of oral corticosteroids in patients…

Decentralized Technologies See Growth in Life Sciences Industry
Medicine

Decentralized Technologies See Growth in Life Sciences Industry

adminJuly 22, 2024

Image Credit: © Andrii Yalanskyi – stock.adobe.com The newly released 2024 ISG Provider Lens global Life Sciences Digital Services report…

PurpleLab Accelerates Clinical Trial Lifecycle with Real-World-Data
Medicine

PurpleLab Accelerates Clinical Trial Lifecycle with Real-World-Data

adminJuly 21, 2024

A large percentage of clinical trials are unable to stay on track. Jason Gagner talked with ACT about how PurpleLab…

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