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…
Category: Medicine
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…
Merck and Moderna Initiate Phase III Study of mRNA-4157 and Keytruda Combination for Non-Small Cell Lung Cancer
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
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
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
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
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
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
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
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
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
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
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
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
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
In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in…
Re-imagining the Labs
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
• 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
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
Credit: luchschenF | stock.adobe.com Findings from the Phase II PATH-HHT trial (NCT03910244) show that pomalidomide significantly lowered the Epistaxis Severity…