SCOPE Summit 2025: Implementing Decentralized Elements
ACT: What are some barriers that stakeholders struggle to overcome when they want to implement more DCT approaches? Tenaerts: What…
Category: Medicine
Applied Clinical Trials February 2025 Issue (PDF)
Applied Clinical Trials February 2025 Issue (PDF) Central Monitoring is Uncovering Emerging Quality Risks in Clinical Trials Replacing Anecdotal With…
Enhancing the Patient Experience Through Site Centricity
ACT: How can more of a focus on site needs and challenges enhance the patient experience? Davidson: Yeah, similar to…
Central Monitoring is Uncovering Emerging Quality Risks in Clinical Trials
Image Credit: © Murrstock – stock.adobe.com Central monitoring, a practice recommended by the FDA over 11 years ago, has become…
The Importance of Language in Patient Engagement
ACT: How can effective localization strategies help sponsors address patient recruitment and retention challenges in global studies, potentially accelerating the…
The Transformative Power of Data Analytics in Clinical Trials
Melissa Hutchens, Vice President, Research & Benchmarking, WCG As clinical trial complexity, duration, and cost continue to rise, life sciences…
Phase III REGENCY Trial Confirms Gazyva/Gazyvaro Significantly Improves Kidney Outcomes in Lupus Nephritis Patients
Credit: Rasi | stock.adobe.com Updated results from the Phase III REGENCY trial (NCT04221477) show that patients with lupus nephritis administered…
Peter Ronco Offers Tips to Small Biopharma Companies on Properly Scaling Clinical Programs
ACT: What advice do you have for small biopharma companies looking to scale their clinical programs without overextending resources? Ronco:…
Embracing Change and Intentionally Living ‘a Life of Why’
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. I was recently invited to deliver a keynote…
Why Clinical Research Leaders Flock to SCOPE Summit
In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at…
Data Collection in Clinical Trials with Multiple Caregivers
Reliable data is critical for making informed decisions about the efficacy and safety of new treatments in clinical trials. While…
Navigating Ineligibility Conversations with Clinical Trial Patients
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In clinical trials, every conversation with a patient carries weight, but few…
Tecentriq Falls Short in Phase III Trial in Post-Surgery Triple-Negative Breast Cancer Patients
Credit: Mopic | stock.adobe.com The addition of the immune checkpoint inhibitor Tecentriq (atezolizumab) to postoperative chemotherapy was not found to…
Rajneesh Patil of IQVIA Highlights the Use of AI/ML in Improving Overall Cycle Times and Clinical Development
ACT: Can you share a few examples of how artificial intelligence/machine learning (AI/ML) can mitigate risks that have traditionally impacted…
Setting the Tone for the Patient and Site Journey
Continuing on Day 2 of this year’s SCOPE Summit in Orlando, a noteworthy session examined ways to better recognize and…
Veeva’s Drew Garty Discusses Pragmatic Clinical Trials
ACT: What are some of your key takeaways from the panel you participated in on pragmatic trials? Garty: Going in,…
Emmes’ Peter Ronco on Small Biopharma & Clinical Trial Partnerships
ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma session.…
The SGM Alliance SOGI Business Case
Day 2 of this year’s SCOPE Summit in Orlando continued with an eye-opening discussion centered on driving progress for sexual…
What Success Could Look Like in Converging Clinical Research and Care—And How to Get There
This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma, and Mark…
Updated BREAKWATER Trial Data Show Significant Survival Improvement with Braftovi Combination in Metastatic Colorectal Cancer
Credit: Rasi | stock.adobe.com Updated topline data from the Phase III BREAKWATER trial (NCT0460742) show the combination of Braftovi (encorafenib)…
AZALEA-TIMI 71 Trial Shows Abelacimab Significantly Reduces Bleeding Events vs. Xarelto in AFib Patients
Results of the Phase IIb AZALEA-TIMI 71 trial published in The New England Journal of Medicine show that abelacimab produced…
Answering Critical Research Questions in Multiple Myeloma
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation…
Built for Complexity, Designed for Simplicity
The promise of modern clinical trials is often hindered by a hidden burden: technology that fails to address the realities…
Filling Evidence Gaps in Clinical Research
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation…
Bexicaserin Produces Significant Seizure Reduction in PACIFIC OLE Trial for Developmental and Epileptic Encephalopathies
Credit: chalani | stock.adobe.com Findings from a 12-month open-label extension (OLE) of the Phase Ib/IIa PACIFIC trial demonstrated patients with…
Kazia Therapeutics Launches Clinical Trial Evaluating Paxalisib in Combination with Keytruda or Lynparza for the Treatment of Advanced Breast Cancer
Image Credit: © Crystal light – stock.adobe.com Kazia Therapeutics has announced the regulatory approval and launch of its new clinical…
Merck Stops HYPERION Trial for Winrevair in PAH Following Positive ZENITH Trial Results
Credit: samunella | stock.adobe.com Merck has announced an early end to the Phase III HYPERION trial (NCT04811092) evaluating Winrevair (sotatercept-csrk) in…
Understanding Motives Behind Participation in Cancer Clinical Trials
Image credit: © putilov_denis – stock.adobe.com Clinical research is critical to discovering life-changing therapies for patients, especially in the cancer…
Multiple Myeloma Research Foundation’s Horizon Clinical Trial Program
In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation…
New Data Links Decentralized Clinical Trial Approaches to Improved Diversity in Patient Populations
Image credit: © FlowStudio – stock.adobe.com Medable has shared new data from the Tufts Center for the Study of Drug…
Updated INAVO120 Trial Data Show Overall Survival Improvement with Itovebi Combination in Certain Type of Advanced Breast Cancer
Credit: Sebastian Kaulitzki | stock.adobe.com Updated findings from the Phase III INAVO120 trial (NCT04191499) show that the combination of Itovebi (inavolisib)…
Elevidys Shows Continued Promise in Phase III EMBARK Trial for the Treatment of Duchenne Muscular Dystrophy
Image credit: luchschenF | stock.adobe.com Roche has announced positive results from the Phase III EMBARK clinical trial of Elevidys (delandistrogene…
Updated CheckMate -8HW Trial Results Show Significant Survival Benefit with Opdivo Plus Yervoy in MSI-H/dMMR Colorectal Cancer
Credit: Dr_Microbe | stock.adobe.com Data released from the ongoing Phase III CheckMate -8HW trial (NCT04008030) showed a significantly improved progression-free…
Pfizer Shares Positive Data from Phase III BREAKWATER Trial of Braftovi Combination Following Accelerated Approval
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Pfizer has announced positive results from the Phase III BREAKWATER clinical trial of…
Current Systematic Challenges Faced by Clinical Operations Professionals
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future…
Technology’s Role in Trial Design Optimization
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future…
Clinical Technology Advancements in 2024
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future…
2025 Trends: Investing in Clinical Data
In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future…
Phase III LEAP-015 Trial Shows Mixed Results for Keytruda-Lenvima Combo in Advanced HER2-Negative Gastroesophageal Cancer
Credit: David A Litman | stock.adobe.com New data released from the Phase III LEAP-015 trial (NCT04662710) show that Keytruda (pembrolizumab)…
Medidata Extends 13-Year Partnership With Tigermed
Image Credit: © lidiia – stock.adobe.com Medidata announced it has extended its 13-year partnership with Tigermed, a provider of research…
Vivacity-MG3 Trial Confirms Nipocalimab’s Efficacy, Safety in Treating Generalized Myasthenia Gravis
Credit: Andrii | stock.adobe.com Data from the Phase III Vivacity-MG3 trial (NCT04951622) show the investigational therapy nipocalimab improved the symptoms…
First Patient Dosed in Phase II Expansion Portion of Acclaim-3 Trial of Reqorsa in Combination With Tecentriq
Image Credit: © iDoPixBox – stock.adobe.com Genprex announced that the first patient has been enrolled and dosed in the Phase…
Decentralized Phase I Trial Highlights Promise of Remote Data Collection to Improve Clinical Research
Credit: JYPIX | stock.adobe.com Findings from a Phase I pharmacokinetic (PK) trial show the promise of a decentralized approach in…
Advarra Unveils New Solution for Study Startup and Research Collaboration
Image Credit: © ipopba – stock.adobe.com Advarra has unveiled its Study Collaboration solution, a new offering designed to automate workflows…
Study Finds Many Randomized Clinical Trials Have Poorly Justified Exclusion Criteria
Credit: photon_photo | stock.adobe.com A new analysis published by JAMA Network Open identified room for improvement in the exclusion criteria…
Establishing the Right Foundation for Patient Safety in 2025
Image Credit: © Egor – stock.adobe.com Digital transformation was a common theme at conferences like World Drug Safety Congress and…
HELIOS-B Trial Confirms Amvuttra Reduces Mortality, Cardiovascular Events in ATTR-CM Patients
Credit: santoelia | stock.adobe.com Findings from the Phase III HELIOS-B trial (NCT04153149) show that patients with transthyretin amyloidosis with cardiomyopathy…
Reaching Diverse Patient Populations With Personalized Treatment Methods
Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including…
Is There Progress Amidst the Swinging Diversity Pendulum?
Image Credit: © Jakub Krechowicz – stock.adobe.com Depending on who you ask, opinions on the state of diversity, equity, and…
Study Shows ePRO Monitoring System Enhances Patient-Centered Care with Improved Communication, Treatment Clarity
Credit: SOMKID | stock.adobe.com The results of a pilot trial (UMIN000049251) published by JAMA Network Open showed the efficacy of…
2025 Trends: Advancements in Data Interoperability
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends…
2025 Trends: Leveraging Data Standards
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends…
STEP UP Trial Shows Semaglutide 7.2 mg Achieves Superior Weight Loss vs. 2.4 mg, Placebo
Credit: 9dreamstudio | stock.adobe.com Topline findings from the 72-week STEP UP trial (NCT05646706) show that semaglutide at a dose of…
Phase III ECHO Trial Results Land AstraZeneca’s Calquence FDA Approval for Previously Untreated Mantle Cell Lymphoma
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has approved AstraZeneca’s Calquence (acalabrutinib), in combination with bendamustine and rituximab, for…
Long-Term KATHERINE Trial Analysis Shows Kadcyla Significantly Improves Survival in HER2-Positive Early Breast Cancer
Credit: LASZLO | stock.adobe.com An updated prespecified final analysis of the Phase III KATHERINE trial (NCT01772472) found that adjuvant treatment…
FDA Approves Eli Lilly’s Omvoh for Crohn’s Disease Based on Phase III VIVID-1 Trial Outcomes
Image Credit: © Sebastian Kaulitzki – stock.adobe.com The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment of moderately…
Streamlining Protocol Development Timelines
In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends…
Five Predictions That Will Drive R&D Effectiveness in 2025
Image Credit: © photon_photo – stock.adobe.com With drug development processes increasing in complexity, companies are working to drive research and…
Suvoda and Greenphire Merge to Create Unified Technology Platform
Image Credit: © lidiia – stock.adobe.com Suvoda and Greenphire have announced an agreement to merge. The merger will unite both…
Telemedicine Considerations When Conducting Decentralized Clinical Trials
Credit: YURII MASLAK | stock.adobe.com Decentralized clinical trials (DCTs) involve some or all trial-related activities conducted at locations other than…
The Path Ahead to Improve DEI in Clinical Trials
Image Credit: Adobe Stock Images/Nvisions On June 26, 2024, the FDA released updated guidelines for diversity, equity, and inclusion (DEI)…
Results from TROPION-Lung05, TROPION-Lung01 Trials Lead to FDA Priority Review for Datopotamab Deruxtecan in NSCLC
Credit: Dr_Microbe | stock.adobe.com Positive efficacy and safety findings from the TROPION-Lung05 (NCT04484142) and TROPION-Lung01 (NCT04656652) clinical trials led the…
Leveraging Real-World Data for Synthetic Control Arms
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical…
Leveraging Artificial Intelligence Alongside RWE/RWD
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical…
Complimenting Traditional Research With Genomic Data in Urology
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical…
Reaching Improved Outcomes With Multiple Data Sources
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical…
Subcutaneous Sarclisa Shows Non-Inferiority to IV Version for Multiple Myeloma in Phase III IRAKLIA Trial
Credit: LASZLO | stock.adobe.com Results of the Phase III IRAKLIA trial (NCT05405166) found that a subcutaneous (SC) version of Sarclisa…
New Study Demonstrates First-Of-Its-Kind Artificial Intelligence Platform, TrialTranslator
Image Credit: © Kaikoro – stock.adobe.com A new study led by Winship Cancer Institute of Emory University and Abramson Cancer…
Talvey Plus Tecvayli Shows Promising Results in Multiple Myeloma but Raises Infection Concerns
Credit: Saiful52 | stock.adobe.com The results of a Phase Ib/II dose escalation and expansion trial (NCT04586426) found that the combination…
Nipocalimab Receives Priority Review From FDA Based on Phase III Vivacity-MG3 Trial Results
Image Credit: Adobe Stock Images/Lila Patel The FDA has granted priority review to Johnson & Johnson’s nipocalimab for the treatment…
Analysis of Clinical Trial Characteristics Show Typical Drug Development Costs Are Lower Than Expected, Skewed by High-Cost Outliers
Credit: alexlmx | stock.adobe.com New research using the characteristics of clinical trials to project the cost of developing new drugs…
FDA Grants Fast Track Designation to Potential New Treatment for Advanced Colorectal Cancer
Image Credit: © Dr_Microbe – stock.adobe.com The FDA has granted Fast Track designation to Marengo Therapeutics’ invikafusp alfa (STAR0602), a…
Rybrevant Plus Lazcluze Shows Over One-Year Survival Boost in EGFR-Mutated NSCLC Patients
Credit: Crystal light | stock.adobe.com Topline results from the Phase III MARIPOSA trial (NCT04487080) show the combination of Rybrevant (amivantamab-vmjw)…
How Medical Writing and Regulatory Affairs Professionals Can Embrace and Deploy Generative AI at Scale
Image Credit: © Kaikoro – stock.adobe.com Over the past two years, generative artificial intelligence (AI) has emerged as a top…
Using Unstructured Data in Clinical Research
In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical…
FDA Issues Draft Guidance on the Role of Artificial Intelligence in Supporting Regulatory Decisions
Image Credit: © JHVEPhoto – stock.adobe.com The FDA announced it has issued a new draft guidance on the use of…
Supporting Clinical Trial Sponsors in Achieving Greater Diversity
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of…
New Study Highlights Gaps in Patient-Reported Outcomes for Cutaneous Chronic GVHD, Calls for Disease-Specific Measures to Improve Clinical Trials
Credit: Halfpoint | stock.adobe.com A new study published by JAMA Dermatology illustrates the significant impact of cutaneous chronic graft-vs-host disease…
Novartis’ Investigational Therapy for Spinal Muscular Atrophy Meets Primary Endpoint in Phase III Clinical Trial
Image Credit: © Rochu_2008 – stock.adobe.com Novartis has announced positive results from the Phase III STEER clinical trial of its…
Finalists Announced for SCOPE’s 9th Annual Participant Engagement Awards
The annual SCOPE (Summit for Clinical Operations Executives) conference has revealed the six finalists for its 9th Annual Participant Engagement…
The Rise of High-Science, High-Touch
Elizabeth Hickman, Chief Business Officer, AustinPx Throughout my career as a chief business officer and strategy executive, I have had…
Brexpiprazole Plus Sertraline Shows Significant PTSD Symptom Improvement with Tolerable Safety Profile in Phase III Trial
Credit: Vitalii Vodolazskyi | stock.adobe.com Findings from a Phase III trial (NCT04124614) published by JAMA Psychiatry demonstrated that brexpiprazole combined…
Translating Between German and English
Image Credit: © Andrii Yalanskyi – stock.adobe.com Translating medical documents between English and German requires more than just a basic…
Our Top 5 Social Media Posts of the Year 2024
October 16th 2024 Podcast Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with…
Adapting to the Increased Use of Decentralized Technologies
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
Our Top 5 Podcast Episodes of 2024
The top five episodes of our podcast in the year 2024, highlighted.
Managing Clinical Technology Overload From a DCT Perspective
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
Animated Explainers Can Be Game-Changers in Cohort Recruitment
Beth Anderson, CEO, Arkitek Scientific Success! The drug you developed has made it to the marketplace, and is being utilized…
Leveraging Lessons Learned to Develop Next-Generation Inhibitors
Image Credit: © Radomir Jovanovic – stock.adobe.com In recent years, antibody-drug conjugates (ADCs) have dominated the oncology space, capturing attention…
Identifying Clinical Trial Diversity Goals With Imperfect Data
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of…
How an FSP PV Partner Helps Ensure Global Compliance
Image Credit: © NicoElNino – stock.adobe.com The pharmacovigilance (PV) regulatory landscape is continually evolving, driven by the effects of technological…
Our Top 5 Most Viewed Conference Video Interviews of 2024
Image Credit: © peshkova – stock.adobe.com Below is a list of the most viewed video interviews from Applied Clinical Trials’…
Elevating Clinical Research Site Relationships With New Budget and Payment Paradigms
Image Credit: © Tierney – stock.adobe.com In the current clinical trial landscape, sponsors and contract research organizations (CROs) are carefully…
Informing Diversity Goals for Clinical Trials
In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of…
Imlunestrant Both as Monotherapy and in Combination Shows Promising Survival Benefits for ER-Positive, HER2-Negative Advanced Breast Cancer
Credit: Mopic | stock.adobe.com The novel agent imlunestrant, administered both as a monotherapy and in combination with Verzenio (abemaciclib), was…
Using Site-Validated Technology
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
The Future of Decentralized Trial Elements
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
Prasinezumab Falls Short of Statistical Significance in Primary Endpoint of PADOVA Trial for Parkinson Disease
Credit: wladimir1804 | stock.adobe.com The investigational monoclonal antibody prasinezumab (Roche; Prothena) fell short of achieving statistical significance for the primary…
eCOA and eConsent within Clinical Trials
In this upcoming roundtable discussion, panelists will discuss the role of eCOA and eConsent in clinical trials. These connected capabilities…
Using Data Patterns to Proactively Improve Study Quality
Image Credit: © FlowStudio – stock.adobe.com Statistical data monitoring (SDM) plays a critical role in ensuring the quality and integrity…
Phase III SWIFT Trials Show Ultra-Long-Acting Biologic Depemokimab Reduces Severe Asthma Exacerbations
Credit: Sebastian Kaulitzki | stock.adobe.com The results of the SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) trials demonstrated that depemokimab administered every…
Palatin Announces Positive Results From Phase IIb BREAKOUT Study
Image Credit: © Minerva Studio – stock.adobe.com Palatin has shared topline data from the Phase IIb BREAKOUT clinical trial, assessing…
Teva and Sanofi Share Positive Results from Phase II Study in Ulcerative Colitis and Crohn’s Disease
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Teva and Sanofi have announced positive results from the Phase IIb RELIEVE UCCD…
Keeping Clinical Trial Sites Informed
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
Long-Term Data Show Lynparza Significantly Improves Survival in Germline BRCA Mutated, HER2-Negative Breast Cancer
Credit: Axel Kock | stock.adobe.com Data from the OlympiA Phase III trial (NCT02032823) show that Lynparza (Olaparib; AstraZeneca, Merck) produced…
Clinical Trials are Getting More Diverse Thanks to AI—and Humans
Image Credit: © Egor – stock.adobe.com It’s widely agreed that clinical trial participants should reflect the populations of people who…
Harnessing Data Analytics and AI for Clinical Trials
Guillaume Gigon, VP of Technology and AI, Innovaderm Clinical trials are becoming increasingly data-driven, with sponsors often expecting real-time data…
DREAMM-7 Trial Shows Blenrep’s Potential to Transform Multiple Myeloma Treatment with Superior Survival
Credit: Saiful52 | stock.adobe.com Detailed results from an interim analysis of the Phase III DREAMM-7 trial (NCT04246047) demonstrated that Blenrep…
How to Boost Inclusivity in Trials Faster and for the Long Term
The Food and Drug Omnibus Reform Act (FDORA) and Food and Drug Administration’s (FDA’s) latest Draft Guidance on Diversity Action…
Applied AI and Advanced Automation in Clinical Trials
Kirk Wroblewski, Chief Information Officer, ProPharma Pharmaceutical services companies and now contract research organizations (CROs) currently find themselves as key…
Peer Exchange: Technology Accessibility
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group…
The Year of AI
Mike Hennessy Jr, president and CEO, MJH Life Sciences® As we near the end of 2024 and reflect on the…
Applied Clinical Trials December 2024 Issue (PDF)
Applied Clinical Trials December 2024 Issue (PDF) Enhancing eCOA Through AI: A Look Ahead to 2025 Applied AI and Advanced…
The Effect of Artificial Intelligence on Clinical Trials, Medicine Creation
Image Credit: Adobe Stock Images/William As the use of artificial intelligence (AI) has greatly accelerated in recent years, AI has…
A Look Ahead to 2025
Shawn Blackburn, President, YPrime Labs The integration of artificial intelligence (AI) and machine learning (ML) into electronic clinical outcome assessment…
Key Takeaways from the 2024 DTRA Annual Meeting
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
Industry Perceptions of Decentralized Clinical Trials
In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed…
AI and Clinical Trials — ‘The Beginning of a Journey’
Image Credit: © Supapeach – stock.adobe.com If artificial intelligence (AI) is the panacea destined to cure the systemic ills of…
Accelerating Breakthroughs with Synthetic Clinical Trial Data
Mandis Beigi, Senior Director Afrah Shafquat, Senior Staff Data Scientist Jia Chen, PhD, Senior Director, Medidata AI Jacob Aptekar, Vice…
Assessing the Strides Made so Far in AI’s Clinical Trial Ascent
Mick Ryan, Vice President, IT, ICON plc Applied Clinical Trials recently spoke with Mick Ryan, vice president of IT at…
First Patient Enrolled in Taiwan for Lantern Pharma’s Phase II NSCLC Clinical Trial
Image Credit: © iDoPixBox – stock.adobe.com Lantern Pharma has announced that the first patient in its Phase II HARMONIC clinical…
Landmark Phase III Trial Results Show Blincyto Plus Chemotherapy Boosts Three-Year Survival in Pediatric Standard-Risk B-Cell ALL
Credit: Arif Biswas | stock.adobe.com Efficacy results from the first pre-specified interim analysis of the Phase III AALL1731 trial (NCT03914625)…
Streamlining Clinical Data Exhaust
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in…
Clinical Technology Consolidation
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in…
Leveraging Artificial Intelligence in Sample Collection
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed…
Technology’s Role in Achieving Greater DE&I in Clinical Trials
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group…
Q&A with Scott Palmese, Worldwide Clinical Trials
Scott Palmese, Executive Director, Site Relationships and DCT Solutions, Worldwide Clinical Trials While decentralized clinical trials (DCTs) have become more…
Phase III MOVe-NOW Trial to Evaluate New Lagevrio Formulation Targeting High-Risk COVID-19 Patients
Credit: oz | stock.adobe.com Merck and Ridgeback Biotherapeutics have announced the initiation of the Phase III MOVe-NOW trial (NCT06667700), which…
Unleashing the Potential for Small, Community-Based Research Sites
Image Credit: © putilov_denis – stock.adobe.com The push for greater racial diversity in clinical trials is essential and widely acknowledged…
Phase II Piranga Trial Shows Promise of Xalnesiran Combination for Hepatitis B Treatment
Credit: bluebay2014 | stock.adobe.com The Phase II Piranga trial (NCT04225715) found that the combination of the novel hepatitis B drug…
Applied Clinical Trials November Recap
This November, Applied Clinical Trials focused on the topic of empowering patients. While technology has streamlined many operational aspects of clinical trials,…
Review Highlights Gaps in Publicly Funded Non-Inferiority Clinical Trials, Call for Better Design and Reporting Practices
Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com A review of 114 publicly funded non-inferiority (NI) trials in the UK show inconsistent adherence…
The Importance of Using Cognition as an Endpoint in Clinical Trials
Image Credit: © Egor – stock.adobe.com Establishing a robust safety and tolerability profile is essential in clinical development. Integrating cognitive…
Obe-Cel Achieves High Response Rates, Durable Outcomes in r/r B-Cell Acute Lymphoblastic Leukemia
Credit: Arif Biswas | stock.adobe.com Obecabtagene autoleucel (obe-cel; Autolus Therapeutics)—a CD19 chimeric antigen receptor (CAR) T-cell therapy—produced high response rates…
Opdivo plus Yervoy Significantly Outperforms Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer
Credit: Dr_Microbe | stock.adobe.com A prespecified interim analysis from the Phase III CheckMate 8HW trial (NCT04008030) found that the combination…
Zai Lab and Novocure Share Positive Results from Phase III Clinical Trial for Pancreatic Cancer
Image Credit: © Matthieu – stock.adobe.com Zai Lab and Novocure have announced positive results from the Phase III PANOVA-3 clinical…
How Rethinking Your Cardiac Monitoring Approach Can Dramatically Improve Trial Outcomes
November 22nd 2024 Article Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT).…
Creating a Global Standard for Data Sources
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed…
Ensuring Proper Standards for Biospecimen Collection and Sample Tracking
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed…
Applied Clinical Trials November 2024 Issue (PDF)
Applied Clinical Trials November 2024 Issue (PDF) Enhancing Empowerment in Patient-Focused Research Are Any Data in Clinical Trials Better than…
Muvalaplin Found to Significantly Lower Lipoprotein(a) Levels, Offering Hope for Cardiovascular Disease Patients
Credit: freshidea | stock.adobe.com Results of the Phase II KRAKEN trial (NCT05563246) show that muvalaplin (Eli Lilly) produced a significant…
Slope and LabConnect Launch Bidirectional API Integration for Clinical Trials
Image Credit: © ipopba – stock.adobe.com Slope and LabConnect have unveiled their new bidirectional API integration. The solution builds on…
Managing the Chain of Custody for Sample Collection
In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed…
Complexities with Managing the Overabundance of Clinical Technology
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in…
Merck Shares Positive Phase III Data from Pulmonary Arterial Hypertension Trial
Image Credit: © photon_photo – stock.adobe.com Merck has announced positive results from its Phase III clinical trial evaluating WINREVAIR (sotatercept-csrk)…
Solving Clinical Technology Challenges with Integration
In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in…
Truqap Combination Shines in Phase III Trial for Prostate Cancer
Image Credit: © Dr_Microbe – stock.adobe.com AstraZeneca has shared positive, high-level results from the Phase III CAPItello-281 clinical trial evaluating…
The Impact of Personalized Support in Clinical Trials
Credit: JP STUDIO LAB | stock.adobe.com On the patient side, patient journey coordinators (PJCs) work closely with sites to address…
GCAR and AstraZeneca Reach Agreement to Evaluate AZD1390 in Phase II/III Clinical Trial
Image Credit: © Aerial Mike – stock.adobe.com The Global Coalition for Adaptive Research (GCAR) and AstraZeneca have reached an agreement to…
FDA Finalizes Decentralized Clinical Trial Guidance
Credit: photon_photo | stock.adobe.com Decentralized clinical trials (DCTs) are clinical trials in which some or all trial-related activities occur at…
AiCure Overview Fact Sheet
Modern clinical trials can be an overwhelming experience for participants, compromising everything from medication adherence and data quality to overall…
Patient Engagement Platform Checklist
Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating…
The Rise of Predictive Engagement Tools in Clinical Trials
November 20th 2024 Article AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from trials and…
Accountability for Implementing Diversity Action Plans
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group…
How We Are Deepening Relationships With Patients
Susan Campbell, Global Head of Patient Recruitment, ICON Tinaya Gray, Global Head, Diversity in Clinical Trials, ICON Patients are more…
Secondary Analysis of COLOFOL Trial Shows No Survival Benefit from Intensive Post-Surgery Follow-Up in Stage II/III Colorectal Cancer
Credit: Dr_Microbe | stock.adobe.com A follow-up analysis of the COLOFOL trial (NCT00225641) showed that differences in the frequency of postoperative…
Abbott Publishes New Strategies to Improve DE&I in Clinical Research as Part of Diversity in Clinical Trials Initiative
Image Credit: © BillionPhotos.com – stock.adobe.com As part of its three-year, multi-million-dollar Diversity in Clinical Trials initiative, Abbott has published…
Pfizer Appoints New Chief Scientific Officer and President, Research and Development
Image Credit: © cbies – stock.adobe.com Following a comprehensive internal and external selection process, Pfizer has announced the appointment of…
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
Credit: Lightgeo | stock.adobe.com Zerlasiran (Silence Therapeutics), a novel N-acetylgalactosamine–conjugated short interfering RNA (siRNA), was found to produce sustained reductions…
Advancing for Patients
Mike Hennessy Jr, president and CEO, MJH Life Sciences® A popular topic of discussion in clinical research in recent years…
Enhancing Empowerment in Patient-Focused Research
Tom Mann, Clinical Solutions Engagement Lead Sarah Kosta, PhD, Clinical Trial Solutions Analyst Samuel Salvaggio, PhD, Senior Trial Design Lead…
Are Any Data in Clinical Trials Better than No Data At All?
Scottie Kern, Executive Director, eCOA Consortium at Critical Path Institute The expectation set on the clinical trial participant around the…
Tirzepatide Reduces Heart Failure Risk, Improves Physical Function in HFpEF Patients
Credit: blacksalmon | stock.adobe.com Findings from the Phase III SUMMIT trial (NCT04847557) show that over a median of two years,…
How Sites Work with Different Types of Labs
In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits…
DREAMM-7 Trial Shows Blenrep Combo Significantly Boosts Overall Survival in Relapsed/Refractory Multiple Myeloma
Credit: luchschenF | stock.adobe.com Interim findings from the Phase III DREAMM-7 trial (NCT04246047) demonstrate that the combination of Blenrep (belantamab…
Peer Exchange: Reaching Underrepresented Patient Populations
In the second part of this roundtable discussion, participants highlight best practices for reaching underrepresented populations and increasing their awareness…
Two-Year Phase III Data Confirm Long-Term Efficacy, Safety of Bimzelx in Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, Ankylosing Spondylitis
Bimzelx. Image Credit: UCB Two-year data from a series of Phase III trials and their open label extensions reinforced the…
Harnessing Unstructured Data and Hospital Interoperability
Mats Sundgren, PhD, Senior, Industry Science Director, i-HD Gabriel Maeztu, Chief Technology Officer and Founder, IOMED Clinical research is fundamental…
Addressing the Health Literacy Roadblock in Patient Recruitment
Image Credit: © Supapeach – stock.adobe.com If clinical trial enrollment is improving, it’s a secret well hidden. PubMed is chock…
How to Balance Data and Trust
Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In the world of clinical trials, patient recruitment remains a persistent challenge.…
Can We Predict Trial Success? From ‘Feasibility’ to Predictive ‘Readiness’
Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. So much has been written about site feasibility…
Advarra Publishes Latest Site-Sponsor-CRO Collaboration Survey Results
Image Credit: © Andrii Yalanskyi – stock.adobe.com Advarra has published results from its 2024 Site-Sponsor-CRO Collaboration Survey. Results include responses…
Twice-Yearly Lenacapavir Injections Significantly Reduce HIV Risk, PURPOSE 2 Trial Shows
Credit: Corona Borealis | stock.adobe.com Full results from the Phase III PURPOSE 2 trial (NCT04925752) further demonstrate the efficacy of…
5 Strategies for Bridging the Sponsor-Site Tech Divide
Drew Bustos, Chief Digital Officer, YPrime In today’s high-stakes clinical trial and drug development environment, technology has become a driving…
Ensuring Consistency with Lab Testing
In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits…
The Power of Simplicity for First-in-Human Studies
Image Credit: © Egor – stock.adobe.com Bringing a new treatment to market is a complex process with many moving parts.…
Long-Term Analysis Shows Tafinlar Plus Mekinist Reduces Mortality Risk in Stage III Melanoma
Credit: David A Litman | stock.adobe.com A final analysis of the Phase III COMBI-AD trial (NCT01682083) show that over eight…
Case studies: How top biopharma companies are scaling protocol optimization and streamlining data acquisition
Case studies: How top biopharma companies are scaling protocol optimization and streamlining data acquisition
Addressing Limited Engagement With Underrepresented Communities in Clinical Research
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent…
The Role of Risk-Based Monitoring in Achieving Greater Diversity
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent…
The Importance of Improving DE&I in Clinical Trials (Episode 1)
In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group…
FDA Approves Johnson & Johnson’s VARIPULSE Pulsed Field Ablation Platform
Image Credit: © JHVEPhoto – stock.adobe.com Johnson & Johnson MedTech has announced the FDA approval of its VARIPULSE Platform for…
Phase III Trial Shows Tezspire Significantly Reduces Nasal Polyps, Congestion in Chronic Rhinosinusitis Patients
Credit: hapsuwanArt | stock.adobe.com Topline results from the Phase III WAYPOINT trial (NCT04851964) show that Tezspire (tezepelumab-ekko; Amgen and AstraZeneca)…
First Patient Dosed in Phase I Trial of ZW191 for the Treatment of Advanced Cancers
Image Credit: © photon_photo – stock.adobe.com Zymeworks announced it has dosed the first patient in its first-in-human Phase I clinical…
Phase III ALIGN Trial Shows Atrasentan Significantly Reduces Proteinuria in High-Risk IgA Nephropathy Patients
Credit: SachinGusain | stock.adobe.com An interim analysis of the Phase III ALIGN trial (NCT04573478) demonstrated that 36 weeks of treatment…
Johnson & Johnson’s Shockwave Medical Shares First Clinical Outcomes Associated With its IVL Catheter
Image Credit: © Tamara – stock.adobe.com Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes…
Once-Weekly Semaglutide Reduces Knee Osteoarthritis Pain, Body Weight in Patients with Obesity, Suggesting Potential to Lower NSAID Use
Credit: TinyUU | stock.adobe.com Results from the STEP 9 trial (NCT05064735) show that patients with obesity administered once-weekly semaglutide experienced…
Six Key Insights from Global Patient Surveys
Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com The clinical trial industry is undergoing significant transformation, particularly in the realm of patient experience.…
Just the Beginning of Improving Diversity Initiatives in Clinical Trials
In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent…
Teva Shares Positive Phase III Data of Schizophrenia Injectable TEV-‘749
Image Credit: © freshidea – stock.adobe.com Teva has shared results from the Phase III SOLARIS (NCT05693935) clinical trial of TEV-‘749…
Trial Shows Semaglutide 2.4 mg Reduces Hospitalizations, Stays in Obese Adults with Cardiovascular Disease
Credit: Matthieu | stock.adobe.com Results from an exploratory post hoc analysis of the Phase III SELECT trial show that semaglutide…
Navigating Diversity and Digital Innovation at the Site-Level
In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives…
Impact of FDA Project FrontRunner on Oncology Drug Development
Discover how early access to investigational therapies can transform cancer treatment, offering patients new hope and improving clinical outcomes. IQVIA’s…
Insights From the SCRS Global Site Solutions Summit
In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives…
Medable Brings Digital Trial Platform to Google Cloud Marketplace
Image Credit: © Blue Planet Studio – stock.adobe.com Medable has announced a collaboration with Google Cloud to bring its Digital…
Phase III Trials Show Long-Term Efficacy of Cobenfy Treating Schizophrenia
Credit: Olivier Le Moal | stock.adobe.com Data from a pair of Phase III trials presented at the 2024 Psych Congress…
Applied Clinical Trials October Recap
This October, Applied Clinical Trials focused on the topic of new-age outsourcing. Led by the rise of integrated research organizations…
Itovebi Combo Boosts Progression-Free Survival in PIK3CA-Mutated HR-Positive, HER2-Negative Metastatic Breast Cancer
Credit: Sara_P | stock.adobe.com Data from the Phase III INAVO120 trial (NCT04191499) published in The New England Journal of Medicine…
Eli Lilly Shares Positive Phase III Data of Mirikizumab for the Treatment of Crohn’s Disease
Image Credit: © Sebastian Kaulitzki – stock.adobe.com Eli Lilly has shared results from two Phase III clinical trials which show…
EMPA-KIDNEY Trial Shows Jardiance Reduces Chronic Kidney Disease Progression, Cardiovascular Death Risk, with Benefits Lasting Up to One Year Post-Treatment
Credit: mi_viri | stock.adobe.com Long-term results of the Phase III EMPA-KIDNEY trial (NCT03594110) demonstrate that two years of treatment with…