Category: Medicine

Image Credit: © Murrstock – stock.adobe.com Central monitoring, a practice recommended by the FDA over 11 years ago, has become a cornerstone of clinical trial […]

Credit: Matthieu | stock.adobe.com The latest findings released from the Phase III EV-302/KEYNOTE-A39 (NCT04223856) trial show that the combination of Padcev (enfortumab vedotin-ejfv) plus Keytruda […]

Melissa Hutchens, Vice President, Research & Benchmarking, WCG As clinical trial complexity, duration, and cost continue to rise, life sciences companies are turning to data […]

Victoria Sherlock, Special Counsel,Tax Controversy and Litigation Practice, Chamberlain Hrdlicka Initially enacted in 1981 as part of the Economic Recovery Tax Act,1 the Federal Research […]

ACT: What are CluePoints’ key objectives for participating in SCOPE 2025, and how do you see the conference shaping the conversation around risk-based quality management? […]

ACT: What advice do you have for small biopharma companies looking to scale their clinical programs without overextending resources? Ronco: The first step is to […]

In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will […]

Reliable data is critical for making informed decisions about the efficacy and safety of new treatments in clinical trials. While self-reporting from the trial participant […]

Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In clinical trials, every conversation with a patient carries weight, but few are as delicate as the […]

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. I was recently invited to deliver a keynote presentation on embracing change. The […]

ACT: Can you share a few examples of how artificial intelligence/machine learning (AI/ML) can mitigate risks that have traditionally impacted clinical trial success? Patil: Sure, […]

ACT: What are the biggest risks small biopharma companies face when partnering on clinical trials, and how can they mitigate them? Ronco: There are a […]

ACT: What are some of your key takeaways from the panel you participated in on pragmatic trials? Garty: Going in, pragmatic trials really talk about […]

Day 2 of this year’s SCOPE Summit in Orlando continued with an eye-opening discussion centered on driving progress for sexual and gender minority (SGM) inclusion […]

ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma session. Can you provide a brief […]

Image Credit: Andy Studna The opening keynote panel on day 1 of SCOPE (Summit for Clinical Operations Executives) Summit 2025 focused on the main stakeholder […]

This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma, and Mark McClellan, MD, PhD, director, Duke-Margolis […]

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple […]

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple […]

The promise of modern clinical trials is often hindered by a hidden burden: technology that fails to address the realities of clinical research. While science […]

Credit: samunella | stock.adobe.com Merck has announced an early end to the Phase III HYPERION trial (NCT04811092) evaluating Winrevair (sotatercept-csrk) in the treatment of pulmonary arterial […]

Credit: chalani | stock.adobe.com Findings from a 12-month open-label extension (OLE) of the Phase Ib/IIa PACIFIC trial demonstrated patients with developmental and epileptic encephalopathies (DEEs) […]

Image Credit: © Crystal light – stock.adobe.com Kazia Therapeutics has announced the regulatory approval and launch of its new clinical trial evaluating the combination of […]

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple […]

Image credit: © putilov_denis – stock.adobe.com Clinical research is critical to discovering life-changing therapies for patients, especially in the cancer space. Knowing this, clinical trial […]

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple […]

Image credit: © FlowStudio – stock.adobe.com Medable has shared new data from the Tufts Center for the Study of Drug Development (CSDD)’s PACT Consortium linking […]

Credit: Sebastian Kaulitzki | stock.adobe.com Updated findings from the Phase III INAVO120 trial (NCT04191499) show that the combination of Itovebi (inavolisib) plus Ibrance (palbociclib) and Faslodex […]

Image credit: luchschenF | stock.adobe.com Roche has announced positive results from the Phase III EMBARK clinical trial of Elevidys (delandistrogene moxeparvovec) for the treatment of […]

In a recent video interview with Applied Clinical Trials, Michael Andreini, president and CEO of the Multiple Myeloma Research Foundation (MMRF), discussed challenges in multiple […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Pfizer has announced positive results from the Phase III BREAKWATER clinical trial of Braftovi (encorafenib) in combination with […]

In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials. Key […]

In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials. Key […]

In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials. Key […]

In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials. Key […]

Credit: David A Litman | stock.adobe.com New data released from the Phase III LEAP-015 trial (NCT04662710) show that Keytruda (pembrolizumab) combined with Lenvima (lenvatinib) and […]

Image Credit: © lidiia – stock.adobe.com Medidata announced it has extended its 13-year partnership with Tigermed, a provider of research and development solutions for the […]

Credit: Andrii | stock.adobe.com Data from the Phase III Vivacity-MG3 trial (NCT04951622) show the investigational therapy nipocalimab improved the symptoms of generalized myasthenia gravis (gMG) […]

Image Credit: © iDoPixBox – stock.adobe.com Genprex announced that the first patient has been enrolled and dosed in the Phase II expansion portion of its […]

Credit: JYPIX | stock.adobe.com Findings from a Phase I pharmacokinetic (PK) trial show the promise of a decentralized approach in remote data collection and monitoring, […]

Image Credit: © ipopba – stock.adobe.com Advarra has unveiled its Study Collaboration solution, a new offering designed to automate workflows in study startup and improve […]

Credit: photon_photo | stock.adobe.com A new analysis published by JAMA Network Open identified room for improvement in the exclusion criteria of randomized clinical trials (RCTs) […]

Image Credit: © Egor – stock.adobe.com Digital transformation was a common theme at conferences like World Drug Safety Congress and Veeva R&D Summit. But what […]

Credit: santoelia | stock.adobe.com Findings from the Phase III HELIOS-B trial (NCT04153149) show that patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM) administered Amvuttra (vutrisiran) achieved […]

Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching […]

Image Credit: © Jakub Krechowicz – stock.adobe.com Depending on who you ask, opinions on the state of diversity, equity, and inclusion in drug development today […]

Credit: SOMKID | stock.adobe.com The results of a pilot trial (UMIN000049251) published by JAMA Network Open showed the efficacy of a user-friendly electronic patient-reported outcome […]

In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical […]

In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical […]

Image Credit: © Dr_Microbe – stock.adobe.com The FDA has approved AstraZeneca’s Calquence (acalabrutinib), in combination with bendamustine and rituximab, for the first-line treatment of adult […]

Credit: 9dreamstudio | stock.adobe.com Topline findings from the 72-week STEP UP trial (NCT05646706) show that semaglutide at a dose of 7.2 mg produced superior weight […]

Credit: LASZLO | stock.adobe.com An updated prespecified final analysis of the Phase III KATHERINE trial (NCT01772472) found that adjuvant treatment with Kadcyla (trastuzumab emtansine; T-DM1) […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com The FDA has approved Eli Lilly’s Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease […]

In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical […]

Image Credit: © photon_photo – stock.adobe.com With drug development processes increasing in complexity, companies are working to drive research and development (R&D) efficiency, a better […]

Image Credit: © lidiia – stock.adobe.com Suvoda and Greenphire have announced an agreement to merge. The merger will unite both clinical technology vendors to offer […]

Credit: YURII MASLAK | stock.adobe.com Decentralized clinical trials (DCTs) involve some or all trial-related activities conducted at locations other than traditional clinical trial sites, such […]

Image Credit: Adobe Stock Images/Nvisions On June 26, 2024, the FDA released updated guidelines for diversity, equity, and inclusion (DEI) in clinical trials. The guidelines, […]

Credit: Dr_Microbe | stock.adobe.com Positive efficacy and safety findings from the TROPION-Lung05 (NCT04484142) and TROPION-Lung01 (NCT04656652) clinical trials led the FDA to award Priority Review […]

In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical research industry could see in […]

In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical research industry could see in […]

In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical research industry could see in […]

Image Credit: © Kaikoro – stock.adobe.com A new study led by Winship Cancer Institute of Emory University and Abramson Cancer Center of University of Pennsylvania […]

Credit: LASZLO | stock.adobe.com Results of the Phase III IRAKLIA trial (NCT05405166) found that a subcutaneous (SC) version of Sarclisa (isatuximab-irfc; Sanofi) administered with the combination […]

Image Credit: Adobe Stock Images/Lila Patel The FDA has granted priority review to Johnson & Johnson’s nipocalimab for the treatment of generalized myasthenia gravis (gMG). […]

Credit: Saiful52 | stock.adobe.com The results of a Phase Ib/II dose escalation and expansion trial (NCT04586426) found that the combination of Talvey (talquetamab) plus Tecvayli (teclistamab) achieved […]

Image Credit: © Dr_Microbe – stock.adobe.com The FDA has granted Fast Track designation to Marengo Therapeutics’ invikafusp alfa (STAR0602), a first-in-class selective dual T cell […]

Credit: alexlmx | stock.adobe.com New research using the characteristics of clinical trials to project the cost of developing new drugs shows that the typical spend […]

Image Credit: © Kaikoro – stock.adobe.com Over the past two years, generative artificial intelligence (AI) has emerged as a top strategic priority in the life […]

Credit: Crystal light | stock.adobe.com Topline results from the Phase III MARIPOSA trial (NCT04487080) show the combination of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) produced a […]

Image Credit: © JHVEPhoto – stock.adobe.com The FDA announced it has issued a new draft guidance on the use of artificial intelligence (AI) in supporting […]

In a recent video interview with Applied Clinical Trials, Sujay Jadhav, CEO of Verana Health, discussed potential advancements the clinical research industry could see in […]

In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical […]

The annual SCOPE (Summit for Clinical Operations Executives) conference has revealed the six finalists for its 9th Annual Participant Engagement Award. This prestigious award recognizes […]

Image Credit: © Rochu_2008 – stock.adobe.com Novartis has announced positive results from the Phase III STEER clinical trial of its investigational therapy, intrathecal onasemnogene abeparvovec […]

Credit: Halfpoint | stock.adobe.com A new study published by JAMA Dermatology illustrates the significant impact of cutaneous chronic graft-vs-host disease (GVHD) on patient health-related quality-of-life […]

Elizabeth Hickman, Chief Business Officer, AustinPx Throughout my career as a chief business officer and strategy executive, I have had the privilege of leading and […]

Credit: Vitalii Vodolazskyi | stock.adobe.com Findings from a Phase III trial (NCT04124614) published by JAMA Psychiatry demonstrated that brexpiprazole combined with sertraline significantly improved the […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com Translating medical documents between English and German requires more than just a basic understanding of both languages. The […]

October 16th 2024 Podcast Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

The top five episodes of our podcast in the year 2024, highlighted.

Credit: Axel Kock | stock.adobe.com Data from the OlympiA Phase III trial (NCT02032823) show that Lynparza (Olaparib; AstraZeneca, Merck) produced a long-term and clinically meaningful […]

Beth Anderson, CEO, Arkitek Scientific Success! The drug you developed has made it to the marketplace, and is being utilized by thousands of people, helping […]

Image Credit: © Radomir Jovanovic – stock.adobe.com In recent years, antibody-drug conjugates (ADCs) have dominated the oncology space, capturing attention and investment as powerful, targeted […]

In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical […]

Image Credit: © NicoElNino – stock.adobe.com The pharmacovigilance (PV) regulatory landscape is continually evolving, driven by the effects of technological advances and political influences on […]

Image Credit: © peshkova – stock.adobe.com Below is a list of the most viewed video interviews from Applied Clinical Trials’ on-site conference coverage in 2024. […]

In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical […]

Image Credit: © Tierney – stock.adobe.com In the current clinical trial landscape, sponsors and contract research organizations (CROs) are carefully considering how they can improve […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Credit: Sebastian Kaulitzki | stock.adobe.com The results of the SWIFT-1 (NCT04719832) and SWIFT-2 (NCT04718103) trials demonstrated that depemokimab administered every six months significantly lowered annual […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Credit: wladimir1804 | stock.adobe.com The investigational monoclonal antibody prasinezumab (Roche; Prothena) fell short of achieving statistical significance for the primary endpoint of time to confirmed […]

Image Credit: © FlowStudio – stock.adobe.com Statistical data monitoring (SDM) plays a critical role in ensuring the quality and integrity of clinical trial data. By […]

In this upcoming roundtable discussion, panelists will discuss the role of eCOA and eConsent in clinical trials. These connected capabilities can offer value in terms […]

Image Credit: © Minerva Studio – stock.adobe.com Palatin has shared topline data from the Phase IIb BREAKOUT clinical trial, assessing the safety, tolerability, and efficacy […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Teva and Sanofi have announced positive results from the Phase IIb RELIEVE UCCD study evaluating duvakitug (TEV’574/SAR447189), a […]

Credit: Mopic | stock.adobe.com The novel agent imlunestrant, administered both as a monotherapy and in combination with Verzenio (abemaciclib), was found to significantly improve survival […]

Image Credit: © Egor – stock.adobe.com It’s widely agreed that clinical trial participants should reflect the populations of people who will ultimately be affected by […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Guillaume Gigon, VP of Technology and AI, Innovaderm Clinical trials are becoming increasingly data-driven, with sponsors often expecting real-time data access and ongoing updates throughout […]

Credit: Saiful52 | stock.adobe.com Detailed results from an interim analysis of the Phase III DREAMM-7 trial (NCT04246047) demonstrated that Blenrep (belantamab mafodotin; GSK) combined with […]

Kirk Wroblewski, Chief Information Officer, ProPharma Pharmaceutical services companies and now contract research organizations (CROs) currently find themselves as key members of the knowledge community. […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® As we near the end of 2024 and reflect on the year that was for clinical […]

Applied Clinical Trials December 2024 Issue (PDF) Enhancing eCOA Through AI: A Look Ahead to 2025 Applied AI and Advanced Automation in Clinical Trials Leveraging […]

Image Credit: Adobe Stock Images/William As the use of artificial intelligence (AI) has greatly accelerated in recent years, AI has been moving to reshape the […]

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics […]

Shawn Blackburn, President, YPrime Labs The integration of artificial intelligence (AI) and machine learning (ML) into electronic clinical outcome assessment (eCOA) technologies promises to revolutionize […]

Rajneesh Patil, Vice President, Digital Innovation, IQVIA Raja Shankar, Vice President, Machine Learning, Research and Development Solutions, IQVIA Research and development industry stakeholders are recognizing […]

In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized […]

Image Credit: © Murrstock – stock.adobe.com Central monitoring is highly effective in detecting emerging quality issues in clinical trials, but debate continues over its use […]

Mandis Beigi, Senior Director Afrah Shafquat, Senior Staff Data Scientist Jia Chen, PhD, Senior Director, Medidata AI Jacob Aptekar, Vice President Yahav Itzkovich, Senior Engagement […]

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. Clinical trials professionals face a host of challenges: for some, it’s the complexity […]

Image Credit: © iDoPixBox – stock.adobe.com Lantern Pharma has announced that the first patient in its Phase II HARMONIC clinical trial has been enrolled and […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

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 and durable outcomes with limited […]

This November, Applied Clinical Trials focused on the topic of empowering patients. While technology has streamlined many operational aspects of clinical trials, it is also being leveraged […]

Credit: bluebay2014 | stock.adobe.com The Phase II Piranga trial (NCT04225715) found that the combination of the novel hepatitis B drug xalnesiran plus an immunomodulator produced […]

Credit: oz | stock.adobe.com Merck and Ridgeback Biotherapeutics have announced the initiation of the Phase III MOVe-NOW trial (NCT06667700), which will assess a new formulation […]

Scott Palmese, Executive Director, Site Relationships and DCT Solutions, Worldwide Clinical Trials While decentralized clinical trials (DCTs) have become more popular in recent years, some […]

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics […]

Image Credit: © putilov_denis – stock.adobe.com The push for greater racial diversity in clinical trials is essential and widely acknowledged across the industry as most […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com A review of 114 publicly funded non-inferiority (NI) trials in the UK show inconsistent adherence to best practices, with high […]

In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in clinical research technology. He highlighted […]

Image Credit: © Egor – stock.adobe.com Establishing a robust safety and tolerability profile is essential in clinical development. Integrating cognitive assessments into trial protocols enhances […]

In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in clinical research technology. He highlighted […]

Image Credit: © Matthieu – stock.adobe.com Zai Lab and Novocure have announced positive results from the Phase III PANOVA-3 clinical trial. The study, evaluating the […]

In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in clinical research technology. He highlighted […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

November 22nd 2024 Article Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of […]

Credit: Lightgeo | stock.adobe.com Zerlasiran (Silence Therapeutics), a novel N-acetylgalactosamine–conjugated short interfering RNA (siRNA), was found to produce sustained reductions in time-averaged lipoprotein(a) levels of […]

Applied Clinical Trials November 2024 Issue (PDF) Enhancing Empowerment in Patient-Focused Research Are Any Data in Clinical Trials Better than No Data At All? Harnessing […]

Credit: freshidea | stock.adobe.com Results of the Phase II KRAKEN trial (NCT05563246) show that muvalaplin (Eli Lilly) produced a significant reduction in lipoprotein(a) levels with […]

Image Credit: © ipopba – stock.adobe.com Slope and LabConnect have unveiled their new bidirectional API integration. The solution builds on the existing collaboration between the […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in clinical research technology. He highlighted […]

Image Credit: © photon_photo – stock.adobe.com Merck has announced positive results from its Phase III clinical trial evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial […]

In a recent video interview with Applied Clinical Trials, Jeff Sidell, PhD, chief technology officer, Advarra, discussed current challenges in clinical research technology. He highlighted […]

Image Credit: © Dr_Microbe – stock.adobe.com AstraZeneca has shared positive, high-level results from the Phase III CAPItello-281 clinical trial evaluating Truqap (capivasertib) in combination with […]

Credit: JP STUDIO LAB | stock.adobe.com On the patient side, patient journey coordinators (PJCs) work closely with sites to address challenges that extend beyond medical […]

Image Credit: © Aerial Mike – stock.adobe.com The Global Coalition for Adaptive Research (GCAR) and AstraZeneca have reached an agreement to evaluate AstraZeneca’s compound, AZD1390, in […]

Credit: photon_photo | stock.adobe.com Decentralized clinical trials (DCTs) are clinical trials in which some or all trial-related activities occur at locations other than traditional clinical […]

Modern clinical trials can be an overwhelming experience for participants, compromising everything from medication adherence and data quality to overall study outcomes. AiCure’s H.Code is […]

Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into […]

November 20th 2024 Article AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from trials and the market. Our solutions go […]

Credit: Dr_Microbe | stock.adobe.com A follow-up analysis of the COLOFOL trial (NCT00225641) showed that differences in the frequency of postoperative follow-up regimens did not produce […]

Susan Campbell, Global Head of Patient Recruitment, ICON Tinaya Gray, Global Head, Diversity in Clinical Trials, ICON Patients are more than participants; they are partners […]

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics […]

Image Credit: © BillionPhotos.com – stock.adobe.com As part of its three-year, multi-million-dollar Diversity in Clinical Trials initiative, Abbott has published ‘Advancing Diversity in Clinical Trials’ […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

Image Credit: © cbies – stock.adobe.com Following a comprehensive internal and external selection process, Pfizer has announced the appointment of Chris Boshoff, MD, PhD, to […]

In a recent video interview with Applied Clinical Trials, Mark Melton, vice president of biospecimen data and operations, Slope, discussed navigating data challenges in clinical […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® A popular topic of discussion in clinical research in recent years has been giving more power […]

Credit: blacksalmon | stock.adobe.com Findings from the Phase III SUMMIT trial (NCT04847557) show that over a median of two years, tirzepatide (Zepbound and Mounjaro; Eli Lilly) […]

Scottie Kern, Executive Director, eCOA Consortium at Critical Path Institute The expectation set on the clinical trial participant around the accurate and timely collection of […]

In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs […]

Credit: luchschenF | stock.adobe.com Interim findings from the Phase III DREAMM-7 trial (NCT04246047) demonstrate that the combination of Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone […]

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. So much has been written about site feasibility over the past decade—even a […]

Bimzelx. Image Credit: UCB Two-year data from a series of Phase III trials and their open label extensions reinforced the long-term efficacy and safety of […]

Image Credit: © Supapeach – stock.adobe.com If clinical trial enrollment is improving, it’s a secret well hidden. PubMed is chock full of studies that bemoan […]

Mats Sundgren, PhD, Senior, Industry Science Director, i-HD Gabriel Maeztu, Chief Technology Officer and Founder, IOMED Clinical research is fundamental for advancing medical knowledge, but […]

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics […]

Hugo Stephenson, MD, Co-Founder and Executive Chair, TrialScreen In the world of clinical trials, patient recruitment remains a persistent challenge. Despite technological advancements, up to […]

In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com Advarra has published results from its 2024 Site-Sponsor-CRO Collaboration Survey. Results include responses from over 200 stakeholders within […]

In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs […]

Drew Bustos, Chief Digital Officer, YPrime In today’s high-stakes clinical trial and drug development environment, technology has become a driving force for streamlining workflows, ensuring […]

In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs […]

Image Credit: © Egor – stock.adobe.com Bringing a new treatment to market is a complex process with many moving parts. It can take between 10 […]

October 31st 2024 Article A top 5 sponsor turned to WCG to recruit expecting mothers for its Phase III RSV vaccine trial. WCG support covered […]

Case studies: How top biopharma companies are scaling protocol optimization and streamlining data acquisition

Credit: TinyUU | stock.adobe.com Results from the STEP 9 trial (NCT05064735) show that patients with obesity administered once-weekly semaglutide experienced a significant reduction in knee […]

Credit: SachinGusain | stock.adobe.com An interim analysis of the Phase III ALIGN trial (NCT04573478) demonstrated that 36 weeks of treatment with atrasentan significantly lowered proteinuria […]

Credit: hapsuwanArt | stock.adobe.com Topline results from the Phase III WAYPOINT trial (NCT04851964) show that Tezspire (tezepelumab-ekko; Amgen and AstraZeneca) produced a clinically meaningful reduction […]

Image Credit: © JHVEPhoto – stock.adobe.com Johnson & Johnson MedTech has announced the FDA approval of its VARIPULSE Platform for the treatment of drug refractory […]

In this roundtable discussion, industry experts gathered to address the state of achieving greater diversity in clinical research. The group highlighted a variety of topics […]

Image Credit: © photon_photo – stock.adobe.com Zymeworks announced it has dosed the first patient in its first-in-human Phase I clinical trial of ZW191. The study […]

In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, […]

Image Credit: © Tamara – stock.adobe.com Shockwave Medical, part of Johnson & Johnson MedTech, has announced the first clinical outcomes associated with the novel Shockwave […]

In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, […]

Credit: Thurstan Hinrichsen/peopleimages.com | stock.adobe.com The clinical trial industry is undergoing significant transformation, particularly in the realm of patient experience. As trials become more patient-centric, […]

In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, […]

Image Credit: © freshidea – stock.adobe.com Teva has shared results from the Phase III SOLARIS (NCT05693935) clinical trial of TEV-‘749 in adult patients diagnosed with […]

Get the initial IRB submission right the first time.

Recruitment and retention may appear to be simplistic in their primary functions. However, for these two processes to be successful, they must be applied in […]

Credit: Sara_P | stock.adobe.com Data from the Phase III INAVO120 trial (NCT04191499) published in The New England Journal of Medicine show Roche’s Itovebi (inavolisib) combined […]

Discover how early access to investigational therapies can transform cancer treatment, offering patients new hope and improving clinical outcomes. IQVIA’s team of experts will discuss […]

Credit: Olivier Le Moal | stock.adobe.com Data from a pair of Phase III trials presented at the 2024 Psych Congress demonstrate that Cobenfy (xanomeline and […]

Image Credit: © Blue Planet Studio – stock.adobe.com Medable has announced a collaboration with Google Cloud to bring its Digital and Decentralized Clinical Trial Platform […]

In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives at the site-level. AI’s impact […]

This October, Applied Clinical Trials focused on the topic of new-age outsourcing. Led by the rise of integrated research organizations (IROs), providers are finding new […]

In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives at the site-level. AI’s impact […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Eli Lilly has shared results from two Phase III clinical trials which show patients treated with mirikizumab sustained […]

In a recent video interview with Applied Clinical Trials, Jimmy Bechtel, vice president, site engagement, SCRS, discussed key challenges and initiatives at the site-level. AI’s impact […]

Image Credit: © iDoPixBox – stock.adobe.com Merck and Moderna have announced the initiation of a Phase III clinical trial evaluating V940 (mRNA-4157) in combination with […]

ACT: Another topic we’ve heard a lot about recently is relationship building between CROs, sponsors, and sites. Why is this so important and what are […]