Category: Medicine

Sustainability in clinical research is key. As complexity and productivity in the industry continue to rise, so does the need for additional resources. According to […]

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 […]

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

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

Christine Senn, Vice President, Site/Sponsor Innovation, Advarra Clinical research is more complicated and expensive than ever. That means the journey from a medical hypothesis to […]

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 dermatitis (AD), according to findings […]

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

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 […]

The shift towards technology and other decentralized approaches in clinical trials has been occurring for years now. The promise of artificial intelligence (AI) in recent […]

Credit: santoelia | stock.adobe.com Headline data from the Phase III SOUL trial found that oral semaglutide (Rybelsus) lowered major adverse cardiovascular events (MACE) by 14% […]

In recent years, the artificial intelligence (AI)-hype train has picked up steam. Its promise has caught the attention of countless industries, and it was only […]

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing […]

Pharmaceutical companies face numerous drug development challenges today, including low drug approval rates, rising drug discovery costs, pressure to accelerate timelines, and ever-evolving regulatory requirements. […]

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing […]

In June, the FDA released its Diversity Action Plan guidance. The document outlines requirements for sponsors on submitting diversity plans to the agency. Sponsors of […]

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Within the push for greater diversity of patient populations in clinical research has come more attention […]

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

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

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

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing […]

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

In a recent video interview with Applied Clinical Trials, Silvio Galea, chief data & analytics officer, WCG, discussed the challenges in the clinical trial industry, emphasizing […]

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 efficacy of more than 99% […]

ACT: You’ve been in the clinical research industry for more than 25 years. Can you please tell us a little about your experience? Bowdish: Yeah, […]

Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses: Current trends and challenges with achieving greater diversity in clinical trials How integrated research […]

Steve Young, Chief Scientific Officer, CluePoints For more than a decade, the FDA and European Medicines Agency have encouraged the use of risk-based quality management […]

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA’s new guidance for multiregional […]

Gerri Gallagher, Head, US Site Engagement, GSK Adam Kinsey, Associate VP, Clinical Operations and Regional Head, North America, Merck Mark Scullion, CEO, Atlas Clinical Research […]

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA’s new guidance for multiregional […]

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA’s new guidance for multiregional […]

Discover how to handle participant payments in global studies with ease. Join us to learn practical tips and new strategies for managing payments across different […]

Join experts from IQVIA Biotech and IQVIA in a webinar focused on enhancing clinical trial conduct by prioritizing patient-centric approaches. Discover innovative strategies for recruiting […]

Credit: luchschenF | stock.adobe.com Pooled data from the Phase III GALAXI trial (NCT03466411) and the Phase III QUASAR maintenance trial (NCT04033445) show that Tremfya (guselkumab) produced […]

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

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA’s new guidance for multiregional […]

Image Credit: © Aerial Mike – stock.adobe.com GSK has shared positive Phase III data from its AReSVi-006 trial of Arexvy, a respiratory syncytial virus (RSV) […]

The holy trinity of trial optimization At the core of trial optimization lies what the authors call the “holy trinity” of optimization and artificial intelligence: […]

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA’s new guidance for multiregional […]

ACT: Could you please tell us a little about Alcon and your role as head for the clinical data organization? Ebert: I lead the data […]

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

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical […]

Image Credit: © Production Perig – stock.adobe.com Emergex Vaccines has announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes […]

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical […]

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

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

Liz Rogers, VP and Head of Global Site and Study Operations at Pfizer, discusses Pfizer’s partnership with Parexel and transition to a functional service provider […]

Credit: luchschenF | stock.adobe.com Findings from the Phase II PATH-HHT trial (NCT03910244) show that pomalidomide significantly lowered the Epistaxis Severity Score and improved health-related quality […]

Tony Southers, Executive Vice President, Head of ICON Strategic Solutions In the new age of sourcing, sponsors are looking beyond the conventional outsourcing or insourcing categories, […]

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical […]

Image Credit: © Crystal light – stock.adobe.com Arcus Biosciences has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus’s investigational HIF-2a […]

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com Results from a survey conducted by two Baltimore medical centers suggest spiritual beliefs and a historically-based distrust of […]

In a recent video interview with Applied Clinical Trials, Erin Erginer, director of product, Certara discussed the growing complexity and volume of data in clinical […]

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

ACT: Looking forward, how will real-world evidence (RWE) drive point-of-care decisions? Gliklich: I love this question because one of the reasons we started OM1 was […]

Image Credit: © FlowStudio – stock.adobe.com Cancer incidence in the United States is on the rise. According to the American Cancer Society, 2024 marks the […]

ACT: Is there any potential for the use of artificial intelligence (AI) in the data collection space? Gliklich: I love that question because we literally […]

Credit: Saiful52 | stock.adobe.com Bristol Myers Squibb (BMS) and 2seventy bio announced the discontinuation of enrollment in the Phase III KarMMa-9 trial (NCT06045806) evaluating Abecma […]

ACT: How can the integration of real-world data (RWD) reduce burden for key stakeholders in a trial such as sites, sponsors, and patients? Gliklich: I […]

This webinar, hosted by Avacare Clinical Research Network, will provide a comprehensive understanding of why clinical trial diversity matters and the key barriers that impede […]

Image Credit: © NicoElNino – stock.adobe.com As the field of clinical research undergoes rapid evolution, so too must the methodologies employed to safeguard patient participants. […]

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

ACT: What are some key regulatory requirements or challenges that need to be addressed when using real-world data (RWD)? Gliklich: Before I dive into what’s […]

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

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

Image Credit: © Jakub Krechowicz – stock.adobe.com While cancer affects all demographics, there is a noticeable difference in burden within underrepresented populations. According to the […]

Image Credit: © Christoph Burgstedt – stock.adobe.com IDEAYA Biosciences has shared positive interim Phase II data for darovasertib in neoadjuvant uveal melanoma (UM). Additionally, IDEAYA […]

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

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

ACT: You have an upcoming session on “Transforming Clinical Trials: From Reactive to Predictive.” What are some of the main points that will be discussed […]

Image credit: Artur | stock.adobe.com Data from the ALITHIOS open-label extension and Phase IIIb OLIKOS trials demonstrated the efficacy of Kesimpta (ofatumumab) in reducing disability […]

ACT: What are some key considerations sponsors should be mindful of when aligning their decision-making process with the timeline of a trial? Lwoff: Ultimately, understanding […]

DPHARM’s “How Pharma is Shifting Operating Models for More Efficient Clinical Trials” session Sometimes, the innovation in things is to just stop and simplify. DPHARM […]

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

Image credit: THITIPORN | stock.adobe.com Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq) produced a significant improvement in progression-free survival […]

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

Image credit: freshidea | stock.adobe.com Findings from the Phase III NIAGARA trial (NCT03732677) show that Imfinzi (durvalumab) in combination with chemotherapy significantly improved event-free survival […]

DPHARM’s “How Do You Make Scaling eSource EHR a Reality?” session Along its “New Approaches to Scale eSource EHR and Accelerate Clinical Development” track, Day […]

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

ACT: You have an upcoming session on “Harnessing AI/ML to Drive Sustained Community Engagement for Diverse Clinical Trial Participation.” What will be the premise of […]

Image credit: Nathan Devery com | stock.adobe.com Findings from the Phase IIIb/IV DESTINY-Breast12 trial (NCT04739761) show Enhertu (trastuzumab deruxtecan) led to significant overall and intracranial […]

DPHARM’s “Examining Short and Long-Term ROI of DCT Deployment” session One of the first presentations to kick off DPHARM 2024 (following the patient keynote) was […]

Image credit: Matthieu | stock.adobe.com Updated data from the Phase III HIMALAYA trial (NCT03298451) show the combination of Imfinzi (durvalumab) plus Imjudo (tremelimumab) produced an unprecedented improvement […]

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

Gabriel Bohl, PharmD, FTOPRA, Director, Regulatory Affairs, ICON plc In the rapidly evolving field of biologics, strategic chemistry, manufacturing, and controls (CMC) play a crucial […]

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

Image credit: Dr_Microbe | stock.adobe.com Results from the first planned interim analysis of the Phase III ADRIATIC trial (NCT03703297) show adjuvant treatment with Imfinzi (durvalumab; AstraZeneca) […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Throughout 2024, we have witnessed a multitude of advancements in the clinical research industry—many of them […]

Applied Clinical Trials September 2024 Issue (PDF) Aligning Technology and Oversight A New Regulatory Road in Clinical Trials: Digital Twins Bridging Patient Support Gaps While […]

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

Gen Li, PhD, MBA, CEO and Founder, Phesi In recent decades, the complexity of clinical development has grown considerably. One study found that in the […]

ACT: What are the most impactful changes that companies need to be aware of? Neuberger: It was a different regulatory framework. Regulation is something is […]

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

Craig Popovich, Associate Director, Implementation CIPP/E, Greenphire Solving site and sponsor clinical trial pain points with technology is hardly a new concept, but the constantly […]

Dee DeOliviera, senior director, global regulatory operations, Cerevel (now part of AbbVie) The evolving regulatory landscape in clinical research was an important topic covered at […]

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

Gadi Saarony, CEO, Advarra Stripped down to its fundamentals, drug development requires diverse participant representation for safe and effective treatments. But “diversity” has much broader […]

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

Attend this new, interactive webinar and join experts who reveal how sponsors can leverage technology to drive study efficiency. Learn to boost success by understanding […]

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

Image credit: magicmine | stock.adobe.com Trial results show that edoxaban monotherapy reduced the risk of the primary net clinical outcome compared to dual antithrombotic therapy […]

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

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

Image Credit: © Minerva Studio – stock.adobe.com Eli Lilly has shared positive study data from its QWINT clinical trial program evaluating once weekly insulin efsitora […]

Image Credit: © NicoElNino – stock.adobe.com Veeva Systems has announced the newest release of Veeva Site Connect. New capabilities of the solution are headlined by […]

Image Credit: Adobe Stock Images/Generative AI In the past few years, there has been more of a focus on equity, diversity, and inclusion (EDI) within […]

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

Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards Initiative (CRISI) Investigative sites typically have a […]

Image credit: alexlmx | stock.adobe.com Data from the Phase III PALISADE trial (NCT05089084) demonstrated that plozasiran (Arrowhead) significantly reduced triglyceride levels and decreased incidence of […]

Image Credit: © fotovapl – stock.adobe.com Valneva and Pfizer have shared positive Phase II results from their study of VLA15, a Lyme disease vaccine candidate. […]

Do you know how AI can inform clinical development planning and drive competitive advantage? In this webinar, learn how AI can be used to simulate […]

Image Credit: Adobe Stock Images/Lila Patel Johnson & Johnson has announced the submission of a Biologics License Application (BLA) to the FDA for nipocalimab. This […]

July 30th 2024 Article Do you leverage a quality-first mindset as you evaluate clinical trial technology? When you evaluate eCOA and IRT solutions, quality cannot […]

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

ACT: What are some trends that you’re currently seeing with patient reimbursement? I mentioned the cost of travel reimbursement, those things have dramatically increased in light […]

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

Korey Nevitt (Executive Director, Site Partnerships) talked with ACT about what makes Dr. Vince Clinical Research (DVCR) solutions for clinical pharmacology and multi-site studies unique. […]

Image Credit: Adobe Stock Images/Best Results from a recent Phase II clinical trial conducted by Johns Hopkins Kimmel Cancer Center in association with the University […]

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

Image Credit: © Rasi – stock.adobe.com Novartis has shared positive results from its Phase III study of Leqvio (inclisiran) in patients who were at low […]

ACT: What impact does patient data access have on elements such as forecasting, budgeting, and enrollment? Murphy: Well, there are a lot of variants in […]

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

ACT: What are some challenges that stakeholders are currently seeing with budgeting and analytics in their trials? Murphy: Well, the budgeting process has got a […]

Image credit: Dr_Microbe | stock.adobe.com An analysis of retrospective and prospective cohort studies finds that diabetes likely elevates the risk of developing tuberculosis (TB), both […]

Image Credit: © AntonioDiaz – stock.adobe.com While the height of the COVID-19 pandemic is well behind us, its effects have been long-lasting. Postacute sequelae of […]

Image credit: fizkes | stock.adobe.com In the pivotal Phase III OASIS 1 and 2 trials, elinzanetant achieved a statistically significant decrease in the frequency and […]

Image Credit: © peshkova – stock.adobe.com Walgreens and the Biomedical Advanced Research and Development Authority (BARDA) have announced a strategic partnership to increase innovation in […]

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

ACT: What are your thoughts on the FDA’s recently released Diversity Action Plan Guidance? How will this affect sponsors moving forward? Moultrie: I am a […]

ACT: What areas of trial design should stakeholders be focusing on the most to increase diversity within their studies? Moultrie: Once we account for access, […]

Image credit: Crystal light | stock.adobe.com Findings from a Phase III trial (NCT03709264) show that intravenous (IV) infusion of amino acids in adults undergoing cardiac […]

Image Credit: © Dr_Microbe – stock.adobe.com The FDA has cleared an Investigational New Drug (IND) application for an open-label, multicenter, Phase I/II trial of GLPG5101 […]

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

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

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

Image Credit: © Andrii Yalanskyi – stock.adobe.com Researchers at Tufts CSDD at the Tufts University School of Medicine, in collaboration with Global Clinical Supplies Group […]

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

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

Applied Clinical Trials July/August 2024 Issue (PDF) Streamlining Clinical Trials with eSource: Insights from MSK Decentralized Clinical Trials: Bust or Breakthrough? The Evolution of CRAACO: […]

Mats Sundgren, PhD, Industry Science Director, i-HD Gynet Santiago, Clinical Research Coordinator, Memorial Sloan Kettering Cancer Center (MSK) Joseph Lengfellner, Sr. Director, Memorial Sloan Kettering […]

Joachim Lövin, Workstream Lead on Modernizing Clinical Trial Conduct, TransCelerate BioPharma Inc., and DCT Specialist, Novo Nordisk In the following Q&A, Joachim Lövin, a specialist […]

What should be top of mind for stakeholders when they are deciding what clinical technology is best for their individual studies? Easy: I think top […]

Image Credit: Adobe Stock Images/pakbung The FDA has granted Breakthrough Therapy Designation and Priority Review to AstraZeneca’s Infimzi (durvalumab), indicated for the treatment of limited-stage […]

Image Credit: Adobe Stock Images/arti om Pfizer and BioNTech announced that their mRNA-based combination vaccine program aimed at combating both influenza and COVID-19 in individuals […]

Image Credit: © Aerial Mike – stock.adobe.com Incyte has shared positive Phase III results of its CD19-targeting monoclonal antibody, Monjuvi (tafasitamab). The study evaluated the […]

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

Decentralized clinical trials (DCTs) are shapeshifting. Originally piloted 15 years ago and more recently catalyzed by the COVID-19 pandemic, DCTs took center stage in 2020 […]

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

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

Benjamin Marcum, MD, family practitioner, Stephenville Medical and Surgical Clinic, Privia Health Emerging investigators play a vital role in bringing new patient populations to clinical […]

Image Credit: Adobe Stock Images/Mahmud Pfizer announced top-line results from the ongoing Phase III MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe […]

Image Credit: Adobe Stock Images/Media Srock Results from a Phase III clinical trial demonstrated that Aldeyra Therapeutics’ Reproxalap demonstrated a significantly reduced ocular discomfort, a […]

Image Credit: © photon_photo – stock.adobe.com To date, eConsent adoption and tangible study data about eConsent outcomes are limited. The most crucial factor contributing to […]

ACT: What are some patient-centric advancements you are looking forward to seeing in the next five years? Keunen: The big thing today is clearly AI […]

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

ACT: What do technology vendors need to focus on most when creating patient-centric solutions? Keunen: It seems obvious, but ask the patients. Many don’t ask […]

Jon Ernst talked with ACT about how PCM Trials are harmonizing various elements in the decentralized clinical trial process. Learn More About: The benefits of […]

ACT: As a patient yourself, what specific features or functions do you look for in technology? Keunen: I went through some difficult times with my […]

Image credit: Saiful52 | stock.adobe.com The results of a Phase III trial show that the combination of Sarclisa (isatuximab-irfc; Sanofi) plus lenalidomide, bortezomib, and dexamethasone […]

Vito Romita, PhD, MSc, Senior Director, Global Project Management, Hematology/Oncology Therapeutic Unit, PPD clinical research business, Thermo Fisher Scientific Introduction August 30, 2017, was historic […]

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

Image credit: adimas | stock.adobe.com Results from the Phase II UNITY trial demonstrated that nipocalimab delayed or stopped the development of severe fetal anemia requiring […]

Image Credit: © Egor – stock.adobe.com Concentric Analgesics has shared positive Phase II data for its leading postsurgical pain management candidate, vocacapsaicin. The water-soluble prodrug […]

Image credit: 9nong | stock.adobe.com A Phase III trial found that adding olanzapine to moderately emetogenic chemotherapy (MEC) regimens consisting of oxaliplatin, carboplatin, or irinotecan, […]

Image Credit: © Africa Studio – stock.adobe.com Bayer has shared new data from the Phase III FINEARTS-HF clinical trial, showing that its Kerendia (finerenone) achieved […]

ACT: Where do you see the use of large language models (LLMs) in clinical trials in five years? Kondru: The mission of the vision statement […]

Image Credit: © ckybe – stock.adobe.com According to new data revealed by Eli Lilly, tirzepatide significantly improved heart failure symptoms and physical limitations in adults […]

Image credit: Sebastian Kaulitzki | stock.adobe.com New clinical data published by JAMA Network Open indicates that immune checkpoint inhibitor (ICI) therapy may not be the […]

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

Image credit: LASZLO | stock.adobe.com The combination of Blenrep (belantamab mafodotin), bortezomib, and dexamethasone (BVd) demonstrated a significant benefit in progression-free survival (PFS) compared to […]

Join experts to explore regulatory strategies, clinical challenges, and operational models that speed up trials and bring patient treatments. Register Free: https://www.appliedclinicaltrialsonline.com/act_w/design-to-delivery Event overview Explore […]

ACT: Are there any opportunities for these AI models to leverage data such as real-world data (RWD)? If so, how? Kondru: As we all know, […]

Norman M. Goldfarb, executive director of the Site Council and executive director of the Clinical Research Interoperability Standards Initiative (CRISI) Study sponsors want clinical research […]

Image credit: grinny | stock.adobe.com Antihypertensive medications may improve target organ damage (TOD) in patients with masked hypertension compared to placebo, according to data from […]

Image Credit: © PIC4U – stock.adobe.com Evorpacept, a CD47 blocker, has returned positive data from the Phase II ASPEN-06 clinical trial. ALX Oncology’s potential therapy, […]

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

Image Credit: © Aerial Mike – stock.adobe.com PepGen has shared positive data from the CONNECT1-EDO51 Phase II trial (NCT06079736) of its lead investigational candidate, PGN-EDO51 […]

Image credit: Peter Hansen | stock.adobe.com Findings from a double-blind study (NCT05236517) show that once-daily oral semaglutide at a dose of 50 mg lowered body […]

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

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

Image Credit: © photon_photo – stock.adobe.com NewAmsterdam Pharma has shared positive results from its pivotal Phase III BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in patients […]

Image credit: Crystal light | stock.adobe.com Felzartamab demonstrated a potential therapeutic benefit and an acceptable safety and adverse event (AE) profile in patients with antibody-mediated […]

Image Credit: © Ezume Images – stock.adobe.com ViiV Healthcare has shared initial results from the 48-week Phase IV PASO DOBLE clinical trial (NCT04884139) investigating the […]

Image credit: Sebastian Kaulitzki | stock.adobe.com An analysis of two randomized clinical trials (NCT03398148 and NCT03398135) found that Skyrizi (risankizumab; AbbVie, Boehringer Ingelheim) increased rates […]

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

ACT: What kind of impact do you hope DIA and its conferences have within the clinical trials industry? Pierce: DIA really strives to be a […]

Jim Wahl, vice president, client services, TruLab In the clinical trial ecosystem these days, patient-centricity has become quite the buzzword. And for good reason: Incorporating […]

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

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

ACT: What are your goals or objectives for DIA for the remainder of the year? Pierce: There are so many things that we’re looking to […]

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

ACT: When it comes to clinical trials specifically, what do you think some of the most relevant themes were at DIA? Pierce: I think it […]

ACT: What were your impressions of the sessions at DIA? Pierce: The sessions that I saw that were the most well attended really had extensive presence […]

Image Credit: © Ольга Тернавская – stock.adobe.com Emerging data from the Phase III DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) clinical trials for the treatment […]

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

Large CROs operate with a one-size fits all approach, when this no longer worked for a late-stage clinical biopharmaceutical company, they turned to Catalyst Flex […]

A large percentage of clinical trials are unable to stay on track. Jason Gagner talked with ACT about how PurpleLab uses real-world-data to better inform […]

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

Image Credit: © Blue Planet Studio – stock.adobe.com Rett syndrome, a rare genetic neurological and developmental disorder that primarily affects girls, presents specific challenges in […]