Category: Medicine

Image credit: JeromeCronenberger | stock.adobe.com Findings from a Phase II/III study show postexposure prophylaxis with Paxlovid (nirmatrelvir–ritonavir; Pfizer) for five or 10 days failed to […]

Image Credit: © yodiyim – stock.adobe.com Teva Pharmaceuticals has shared new results from the Phase III SPACE clinical trial (NCT03539393) evaluating the efficacy of AJOVY […]

Image Credit: © Pixel-Shot – stock.adobe.com Emerging two-year data from a pair of Phase III studies—Pagoda (NCT04108156) and Pavilion (NCT04503551)—evaluating Roche’s Susvimo (Port Delivery System […]

Image Credit: © Dr_Microbe – stock.adobe.com The Phase III ARANOTE trial (NCT04736199) of Bayer’s NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) in patients with metastatic […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com The newly released 2024 ISG Provider Lens global Life Sciences Digital Services report has found that life sciences […]

Image Credit: © NicoElNino – stock.adobe.com There is no doubting the impact of the COVID-19 pandemic on clinical research. According to a study published in […]

Image Credit: © jarun011 – stock.adobe.com Camurus has shared positive, final, topline results from the ACROINNOVA 2 Phase III clinical trial (NCT04125836). The study evaluated […]

Tom deLaubenfels, PhD, Director of Data Science, Strados Labs In respiratory clinical trials, cough frequency monitoring can serve as a valuable endpoint. Despite this, challenges […]

Image credit: Andrew Dorey | stock.adobe.com Findings from the Phase I-II 2022-CM313-ITP trial (NCT05694767) show that an investigational anti-CD38 targeted therapy was able to quickly […]

Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared Artelo Biosciences’ Investigational New Drug application (IND) for ART26.12, a selective fatty acid binding […]

ACT: Does the FDA’s Diversity Action Plan guidance create any additional challenges for sponsors? How can they be addressed? Smith: Well, I think the guidance […]

Image credit: Crystal light | stock.adobe.com Data from the Phase III innovaTV 301/ENGOT-cx12/GOG-3057 trial (NCT04697628) show second- or third-line treatment with Tivdak (tisotumab vedotin-tftv) achieved superior […]

Image Credit: © peterschreiber.media – stock.adobe.com Prelude Therapeutics has announced a new clinical trial collaboration and supply agreement with Merck to evaluate PRT3789 in combination […]

Image credit: PH alex aviles | stock.adobe.com An observational study (NCT06030505) in a real-world setting found that Beyfortus (nirsevimab) lowers the risk of hospitalized respiratory syncytial […]

Image Credit: © Christoph Burgstedt – stock.adobe.com The FDA has granted Fast Track Designation to Obsidian Therapeutics’ OBX-115, a novel engineered tumor-derived autologous T cell […]

Image credit: kh_art | stock.adobe.com Results from the Phase II INTUITT-NF2 trial (NCT04374305) show brigatinib produced radiographic responses across multiple tumor types with a clinical […]

ACT: What are your initial thoughts on FDA releasing the Diversity Action Plan guidance? Smith: My initial thoughts on the FDA releasing their guidance on […]

Image Credit: © VadimGuzhva – stock.adobe.com Pfizer announced it has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor […]

ACT: How can sponsors embed patient and caregiver insights into product vision and design? Birchard: I’m currently a product owner, and I love this question […]

ACT: How can sponsors leverage electronic clinical outcome assessment (eCOA) technologies to facilitate the collection and management of patient-reported outcomes (PROs)? How does this contribute […]

Image Credit: © iDoPixBox – stock.adobe.com IDEAYA Biosciences has shared positive clinical data for the IDE397 Phase II monotherapy expansion dose in methylthioadenosine phosphorylase (MTAP)-deletion […]

ACT: What strategies can sponsors employ to bridge the gaps between study participants and the industry, ensuring open and continuous dialogue and achieving true patient […]

Image Credit: © putilov_denis – stock.adobe.com The FDA has cleared Immorna Biotherapeutics’ Investigational New Drug Application (IND) for JCXH-211 intravenous (IV), a novel, first-in-class self-replicating […]

ACT: Why should sponsors prioritize incorporating patient and caregiver perspectives into clinical trial design and conduct? Birchard: I love this question, because from my perspective, […]

June 27th 2024 Article AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient safety, with the […]

June 27th 2024 Article AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient safety, with the […]

ACT: Looking forward, where do you see the use of artificial intelligence (AI) in clinical trials in five years? Lacroix: We’re going to continue to […]

Discover how streamlining patient screening can help accelerate clinical trials. Simplifying and improving the patient journey and optimized screening processes can help improve clinical trial […]

Tenaerts: It was awaited, so we’re all happy it came out and I think it’s going in the right direction. I think they lay out […]

Image Credit: © photon_photo – stock.adobe.com The FDA has cleared Vir Biotechnology’s investigational new drug (IND) application and granted Fast Track designation for the combination […]

Image Credit: © Aerial Mike – stock.adobe.com The FDA has cleared GT Biopharma’s Investigational New Drug (IND) application for GTB-3650. GT Biopharma will proceed with […]

Image Credit: © Matthieu – stock.adobe.com Sirnaomics has announced its small interfering RNA (siRNA) drug candidate, STP707, showed a strong safety profile and stable disease […]

Nick Slack, Chairman and CEO, START Center for Cancer Research Clinical trials can offer patients who have run out of options with another chance at […]

Image Credit: Adobe Stock Images/Hunterframe Boehringer Ingelheim and Gubra have launched a Phase I clinical trial for BI 3034701, a long-acting triple agonist peptide that […]

Tenaerts: I think it’ll help the industry get more data, actionable data on a diverse population—there’s different ways to do that. You can change your […]

Image Credit: Adobe Stock Images/fotoyou The National Institutes of Health (NIH) has begun a Phase I clinical trial to test the safety of an experimental […]

Image Credit: © Aerial Mike – stock.adobe.com Emerging data released from Sanofi show its CD40L monoclonal antibody, frexalimab, reduced a key biomarker associated with multiple […]

Image Credit: Adobe Stock Images/Lila Patel Results from the Phase III Vivacity-MG3 trial show that Johnson & Johnson’s (J&J) nipocalimab in combination with standard-of-care (SOC) […]

AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient safety, with the AI alerting medical review […]

Introducing OpenBioLLM-Llama3-70B & 8B: Saama’s AI Research Lab Released the Most Openly Available Medical-Domain LLMs to Date

Image credit: shidlovski | stock.adobe.com Phase III trial data published by The New England Journal of Medicine (NEJM) show the efficacy of Dupixent (dupilumab) treating eosinophilic […]

Image credit: Sebastian Kaulitzki | stock.adobe.com The combination of Rybrevant (amivantamab-vmjw; Janssen Pharmaceutical) with Leclaza (lazertinib; Johnson & Johnson) produced significantly improved survival compared to […]

Image credit: Deemerwha studio | stock.adobe.com Patient experience data (PED) are no longer a nice to have; it is emerging as a critical component in […]

ACT: What should industry stakeholders be keeping top of mind when implementing artificial intelligence (AI) into their workflows? Lacroix: When we started thinking, or when […]

ACT: What are the greatest benefits to utilizing artificial intelligence (AI) in data management? Lacroix: Coming from a data management background, there’s of course, across […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com The National Comprehensive Cancer Network (NCCN) has published new results for its latest survey on cancer drug shortages […]

ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial intelligence (AI)? Lacroix: There is a lot […]

Image Credit: © Jakub Krechowicz – stock.adobe.com The FDA has issued a draft guidance which provides details to medical product sponsors on submitting Diversity Actions […]

ACT: What are some of the biggest challenges you are currently seeing with data management in clinical trials? Lacroix: Since I’ve been in industry for […]

Image Credit: © Crystal light – stock.adobe.com Adicet Bio has announced that the FDA has cleared its Investigational New Drug (IND) application to evaluate ADI-270, […]

Image Credit: © terovesalainen – stock.adobe.com Eli Lilly has announced results from its Phase III clinical trials of tirzepatide for the treatment of moderate-to-severe obstructive […]

Image Credit: © putilov_denis – stock.adobe.com In recent years, there has been a growing interest in the use of patient-reported outcomes (PROs) in clinical trials. […]

As medical facilities become more equipped to handle different telemedicine platforms and procedures, more clinical trials are back up and running. This also means more […]

Although biologics and biosimilar drugs only represent 2% of U.S. prescription volume, these naturally sourced medications have recently become the focus of much discussion across […]

Image Credit: Andy Studna In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles, program director, Decentralized Trials and […]

Image credit: Matthieu | stock.adobe.com Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for Tremfya (guselkumab) subcutaneous (SC) induction for […]

Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG. Site activation of new clinical trials remains a top priority […]

ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should be keeping top of mind? How can […]

Image credit: Corona Borealis | stock.adobe.com The clinical research industry has historically operated with a focus on effectively and efficiently delivering therapies that will benefit […]

ACT: How is FDA promoting innovation in clinical trial design and conduct? Cuff Shimooka: It’s a timely question, having just got off a panel discussion […]

Image Credit: Adobe Stock Images/Sebastian Kaulitzki Results from the Phase III CAPItello-290 trial evaluating AstraZeneca’s Truqap (capivasertib) in combination with paclitaxel for patients with locally […]

ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical research? DiCicco: I think there are a […]

ACT: What are you looking forward to working on and achieving with FDA under the renewed CRADA agreement? Hughes: We are so delighted to renew […]

Image credit: Sweettymojidesign | stock.adobe.com Two-year data from the Phase III BE MOBILE 1, BE MOBILE 2, and the open-label extension BE MOVING trials demonstrated […]

Image Credit: © lidiia – stock.adobe.com EQT has announced that the EQT Healthcare Growth Strategy and the EQT Growth Fund have agreed to acquire a […]

Image Credit: Adobe Stock Images/Oksana Smyshliaeva The FDA has granted accelerated approval to Bristol Myers Squibb’s (BMS) Augtyro (repotrectinib), a tyrosine kinase inhibitor (TKI), for […]

ACT: How can we improve shared decision-making practices as ways to improve the quality of care for cancer patients? Buyse: Again, I think the method […]

Image credit: LASZLO | stock.adobe.com Findings from the Phase II MagnetisMM-3 trial (NCT04649359) showed a significant survival benefit with Elrexfio (elranatamab-bcmm) in patients with heavily […]

ACT: How is clinical trial design and analysis changing in response to more comprehensive evaluation methods (methods that consider the full spectrum of patient outcomes)? […]

Image credit: rost9 | stock.adobe.com Findings from the Phase III NextCOVE (NCT05815498) trial of Moderna’s mRNA-1283 showed the next-generation, investigational SARS-CoV-2 vaccine achieved the primary […]

ACT: How can we transform cancer care through more patient-centered research and treatment analysis? Buyse: Just building on what Sebastien just mentioned, the fact that […]

Image Credit: © Kaikoro – stock.adobe.com Lokavant has announced the launch of an artificial intelligence (AI) clinical trial feasibility software solution, Spectrum. According to Lokavant, […]

ACT: What are some of the unique challenges facing oncology trials today? Buyse: Well, I think there are many challenges, but one of them is […]

Image credit: Crystal light | stock.adobe.com Two-year interim data from the Phase III ASSURE trial (NCT03301506) show sustained and long-term efficacy with seladelpar in the […]

Image Credit: © putilov_denis – stock.adobe.com Systematic reviews are a key element of clinical research. While these reviews must be completed in a timely manner, […]

Image credit: artsakon | stock.adobe.com Eli Lilly’s tirzepatide showed superiority to placebo in resolving biopsy-proven metabolic dysfunction-associated steatohepatitis (MASH) with no worsening of fibrosis on […]

Image Credit: © Murrstock – stock.adobe.com We presented an initial review of quality tolerance limit (QTL) adoption trends in the March 2023 issue of Applied […]

Image Credit: © Supapeach – stock.adobe.com A few points to review before we reach the heart of this how-green-are-they-getting look at contract research organizations (CROs) […]

Image Credit: © Катерина Євтехова – stock.adobe.com AbbVie has announced that the first patient has been treated with its investigational ABBV-383 in the CERVINO Phase […]

Julia Sundari, Senior Director of Clinical Design and Analytics, IQVIA In 2023, clinical development productivity rose the highest it has been since 2018, primarily due […]

Michael Cohen, Senior Director, Lead, Environmental Sustainability Robyn Owens, Manager, Recruitment and Engagement Both with the PPD clinical research business of Thermo Fisher Scientific Americans […]

Image credit: Dr_Microbe | stock.adobe.com Elahere (mirvetuximab soravtansine; AbbVie) achieved both the primary and secondary endpoints of the Phase II PICCOLO trial (NCT05041257) in heavily […]

Ken Getz, MBA, Executive Director and Research Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine Raise your hand if […]

Image credit: Crystal light | stock.adobe.com Trial data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting show the potential of Enhertu […]

Image Credit: © Sebastian Kaulitzki – stock.adobe.com Johnson & Johnson has announced new data from the Phase III MARIPOSA study of RYBREVANT (amivantamab-vmjw) in combination […]

Image credit: Chutima | stock.adobe.com Opdivo (nivolumab) combined with Yervoy (ipilimumab) demonstrated a significantly improved survival benefit compared with lenvatinib or sorafenib in the first-line […]

ACT: Looking forward, what does the future of bring-your-own-device (BYOD) adoption look like? Liu: I think it’s already common. I think you’ll see a shift […]

Image credit: Crystal light | stock.adobe.com Treatment with Tagrisso (osimertinib; AstraZeneca) produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) among patients with […]

Image Credit: © Kaikoro – stock.adobe.com Conversations around the impact of artificial intelligence (AI) in the pharmaceutical industry seem to be everywhere, with AI often […]

ACT: What are the differences between consumer- and medical- grade wearables and their uses in clinical settings? Liu: The medical grade devices typically will have gone […]

Image credit: Axel Kock | stock.adobe.com Results from the TROPION-Lung01 Phase III trial (NCT04656652) show datopotamab deruxtecan (Dato-DXd) achieved superior overall survival (OS) compared to […]

Webinar Date/Time: Tuesday, June 25th, 2024 at 11am EDT|8am PDT|4pm BST|5pm CEST

Image Credit: © Jakub Krechowicz – stock.adobe.com Inclusion of diverse populations continues to lag in clinical research. In this article, we will focus on three […]

Image credit: David A Litman | stock.adobe.com The FDA has approved Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) to treat adults with relapsed or refractory (R/R) […]

Image Credit: © Shuo – stock.adobe.com ConcertAI has announced its first-in-category predictive and generative artificial intelligence (AI) solutions. The new suite of solutions, CARA AI, […]

Image credit: art4stock | stock.adobe.com The FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date by three months for the priority […]

ACT: What are some challenges we are currently seeing with data security and accuracy in bring-your-own-device (BYOD) models? Liu: The biggest challenge with BYOD is […]

Image credit: GraphicPapa | stock.adobe.com Since 2016, the FDA has released various guidance documents intended to promote diversity in clinical trials—particularly regarding recruitment of trial […]

Image Credit: © photon_photo – stock.adobe.com Medidata has announced it has been selected by Lexicon Pharmaceuticals to help advance the Phase IIb study, PROGRESS (NCT06203002). […]

Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of […]

Image Credit: © PIC4U – stock.adobe.com Transcenta has announced results from the Phase I/IIa Cohort-G data for Osemitamab (TST001) plus Nivolumab and CAPOX as the […]

Do you know what challenges are encountered by sites when operationalizing study protocols? In this webinar, learn how specific protocol design elements impact sites’ perception […]

Image Credit: © iDoPixBox – stock.adobe.com A study recently published in JAMA Network Open compared response- and progression-based end points in clinical trials and clinical […]

Jeremy Wyatt, CEO of ActiGraph The technology that goes into wearable health monitoring devices has advanced by leaps and bounds in recent years, particularly on […]

Mike Hughes, Chief Product Officer, YPrime The field of drug development is placing a growing emphasis on the importance of patient perspectives. Regulatory bodies are […]

Image Credit: © Murrstock – stock.adobe.com Beaconcure, a provider of artificial intelligence-enabled clinical data validation and automation, has announced a new partnership with contract research […]

Image Credit: Adobe Stock Images/Antonioguillem Sanofi announced positive results from a Phase II study for rilzabrutinib, a promising first-of-its-kind advanced oral treatment for moderate-to-severe asthma. […]

Image Credit: © lidiia – stock.adobe.com Clario has announced a strategic partnership with medical equipment supplier for clinical trials, Emsere. This collaboration will provide a […]

Image Credit: © ipopba – stock.adobe.com From the promise of shrinking pancreatic tumors to a vaccine for Alzheimer’s, groundbreaking clinical research is transforming lives, but […]

Image Credit: Adobe Stock Images/Hero Design Nimbus Therapeutics presented promising data from its Phase 1/2 clinical trial of NDI-101150, a novel HPK1 inhibitor, at the […]

Image Credit: © Aerial Mike – stock.adobe.com Boehringer Ingelheim and OSE Immunotherapeutics have announced a major expansion of their already-existing partnership. The duo will be […]

Image Credit: Adobe Stock Images/Oksana Smyshliaeva Edgewood Oncology announced that it has begun dosing patients as part of a Phase IIa clinical trial of BTX-A51, […]

Image Credit: © Egor – stock.adobe.com While the number of randomized clinical trials (RCTs) for adult participants has increased over time, the number of available […]

Image Credit: © Aerial Mike – stock.adobe.com In a presentation at the 2024 US Pharma and Biotech Summit, Michael Peel, science editor, Financial Times sat […]

Image Credit: Adobe Stock Images/Sebastian Kaulitzki GSK announced promising results from its Phase III clinical trials, SWIFT-1 and SWIFT-2, evaluating depemokimab in adults and adolescents […]

Image credit: Tierney | stock.adobe.com Abstract Background: ChatGPT usage remains limited to administrative and support work among drug developments professionals; however, a small percentage use […]

Image Credit: Adobe Stock Images/Robert Kneschke Eli Lilly announced promising results from the QWINT-2 and QWINT-4 Phase III trials for their once-weekly insulin, efsitora alfa, […]

Image credit: metamorworks | stock.adobe.com Data integrity is an ongoing concern across all R&D organizations, no matter what part of the research lifecycle they’re navigating. […]

ACT: If companies choose not to adopt risk-based approaches, what are some of the largest risks they leave themselves susceptible to? Young: I’ll start. Certainly, […]

David Alsadius, MD, PhD, Senior Medical Director, Oncology Center of Excellence, IQVIA Sergio Sánchez-Gambetta Director, Design Analytics, IQVIA Matt Simmons Senior Director, Oncology Strategy, IQVIA […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® Oncology clinical trials have always been a unique area in the R&D landscape. One of their […]

Panna Sharma, CEO, Lantern Pharma ACT: While reaching the first-in-human stage is a significant achievement, what specific endpoints or biomarkers will you be looking at […]

ACT: What do you think the RBQM space will look like in five years? Will we see any drastic changes in adoption either way? Getz: […]

Image credit: Ban | stock.adobe.com Four-year data from the long-term extension (LTE) of the POETYK PSO clinical trial program found that more than seven in […]

Applied Clinical Trials May 2024 Issue (PDF) A Promising Future for Oncology R&D Where Innovation and Patients Meet to Improve Cancer Care A Fun and […]

Image credit: 9dreamstudio | stock.adobe.com Roche’s dual GLP-1/GIP receptor agonist CT-388 produced positive findings treating obesity and type 2 diabetes in Phase Ib clinical trial.1 […]

Brian S. McGowan, PhD, FACEHP, Chief Learning Officer and Co-Founder, ArcheMedX, Inc. This installment of my column is a little different than most we’ve published […]

Image credit: Dr_Microbe | stock.adobe.com Eisai and Biogen Inc. have initiated a rolling FDA submission for a subcutaneous (SC) version of Leqembi (lecanemab-irmb) to treat […]

Hannah Jones, PhD, Senior Vice President, PBPK Consultancy Services, Certara Masoud Jamei, PhD, Senior Vice President, Research and Development, Certara More than 50 kinase inhibitors (KIs) […]

While Europe is habitually under attack from Big Pharma for the latter’s assertions of failing to encourage clinical trials, patients and carers have now joined […]

Image Credit: © iDoPixBox – stock.adobe.com In an update on the Phase III CheckMate -73L trial, Bristol Myers Squibb announced it did not meet its […]

ACT: What do you make of the results of the study? Was there anything that stood out? Young: Oh, sure. So I mean, as Ken […]

Image credit: MdBabul | stock.adobe.com Keytruda (pembrolizumab; Merck) plus chemotherapy as adjuvant therapy, with or without radiotherapy, in the treatment of patients with newly diagnosed high-risk […]

Image Credit: © putilov_denis – stock.adobe.com Patient enrollment has been a persistent challenge in clinical trials over the years across almost all therapeutic areas. However, […]

ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts? Getz: Yes, absolutely. And let me position […]

Image credit: JHVEPhoto | stock.adobe.com The FDA has notified Moderna that it will be unable to finish reviewing its Biologics License Application (BLA) for the […]

Image Credit: © NicoElNino – stock.adobe.com The Tufts Center for the Study of Drug Development (Tufts CSDD) is conducting an important new empirical study looking […]

ACT: Ken, could you give us an overview of the risk-based quality management (RBQM) study conducted by Tufts? Getz: Yes, absolutely. And let me position […]

Image Credit: Adobe Stock Images/_veiksme_ The Pistoia Alliance, a prominent non-profit advocating for increased collaboration in life sciences R&D, announced a call to action focused […]

Image credit: Jafree | stock.adobe.com Diarrheal diseases place a significant burden on public health in India, particularly among children and vulnerable populations. Unfortunately, diarrhea often […]

Image Credit: © ibreakstock | stock.adobe.com The FDA has granted Breakthrough Device Designation for Teal Health’s Teal Wand, a novel at-home self-collect cervical cancer screening […]

Image credit: koolsabuy | stock.adobe.com The first ever clinical trial conducted to evaluate an experimental treatment for diabetic macular ischemia (DMI) showed positive findings for […]

Image Credit: © Murrstock – stock.adobe.com The FDA has cleared an Investigational New Drug Application (IND) for VYNE Therapeutics’ VYN202, an oral BD2-selective BET inhibitor. […]

Andreas Dreps, Senior VP and Global Head Drug Development Unit, ICON plc Over the years, extensive research and clinical trials have led to the development […]

Image Credit: © Tierney – stock.adobe.com In the design of a randomized clinical trial (RCT), estimations for expected event rate and effect size are needed […]

ACT: What will the feasibility/artificial intelligence (AI) space in clinical trials look like in 5 years? What excites you the most about the future? Nambisan: […]

Are you interested in learning about clinical trial participant payment best practices? Join IQVIA Technologies to learn how an innovative approach to manage participant payments […]

Image credit: Crystal light | stock.adobe.com Merck’s Keytruda (pembrolizumab) combined with trastuzumab, plus fluoropyrimidine- and platinum-containing chemotherapy, demonstrated promising improvements in overall survival (OS) in the […]

Image credit: David A Litman | stock.adobe.com Calquence (acalabrutinib; AstraZeneca) plus standard-of-care chemoimmunotherapy produced a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in […]

ACT: What are some of the biggest mistakes stakeholders tend to make with their feasibility studies? How can those challenges be addressed? Nambisan: So I […]

Image credit: Juan Gärtner | stock.adobe.com The landscape of oncology drug development is rapidly evolving, particularly in the realm of solid tumors. With the emergence […]

Elizabeth Kelchner is the Associate Director of Data Management at Rho Sometimes relationships can continue even when things aren’t working out. However, when it comes to the […]

Image Credit: Adobe Stock Images/freshidea Walgreens and Boehringer Ingelheim have announced a joint venture, which will focus on the growth of diversity and accessibility in […]

ACT: How can feasibility studies be used to safeguard against trial complexities? Nambisan: So I touched on this just briefly in my prior response. But […]

Image Credit: © peshkova – stock.adobe.com An overwhelming amount of cancer patients express willingness to participate in clinical trials; however, only a small portion will […]

ACT: How is artificial intelligence (AI) currently being used in clinical trials to ensure patient centricity? Nambisan: I think it’s a good question, especially since […]

Image Credit: © Shuo – stock.adobe.com As artificial intelligence (AI) technology rapidly evolves, regulators around the world are tasked with aligning safety and reliability standards […]

Image Credit: © lidiia – stock.adobe.com Parexel and Palantir Technologies have announced a new multi-year strategic partnership to leverage artificial intelligence (AI), enhancing clinical trial […]

Image credit: NicoElNino | stock.adobe.com Artificial intelligence (AI) has become a cornerstone in the healthcare and pharmaceutical industry. The introduction of AI-powered devices has facilitated […]

ACT: How can differences across therapeutic areas be used to create more standardized electronic clinical outcome assessment (eCOA) solutions? Mooney: I think it all starts […]

Image credit: Crystal light | stock.adobe.com The FDA has granted Priority Review to GSK’s supplemental Biologics License Application (sBLA) seeking to expand the indication of Jemperli (dostarlimab) […]

Rust Felix, CEO and Co-founder of Slope While the potential of artificial intelligence (AI) has become more popular in the clinical trials space, compliance and […]

Image credit: InfiniteStudio | stock.adobe.com Findings from the Phase IIIb/IV LEVEL UP (NCT05601882) trial demonstrated the superiority of AbbVie’s Rinvoq (upadacitinib) over Dupixent (dupilumab) in the […]

Image credit: Matthieu | stock.adobe.com Compass Therapeutics, Inc’s novel bispecific antibody CTX-009 was granted Fast Track Designation (FTD) by the FDA in combination with paclitaxel […]

Monique Adams, PhD, Executive Director, Global Head of Diversity & Inclusion in Clinical Trials, Sanofi The lack of diversity in clinical trials has been a […]

ACT: Are there currently any regulatory challenges with the use of electronic clinical outcome assessments (eCOAs)? If so, how can they be addressed going forward? […]

Image Credit: © Andrii Yalanskyi – stock.adobe.com A study recently published on JAMA Network Open examined a single center, double-blind, three-group randomized clinical trial for […]

ACT: Specifically in dermatology trials, which provide a lot of unique challenges, could you discuss some of the best practices for navigating the use of […]

Image Credit: © Proxima Studio – stock.adobe.com A study recently published in BMJ Open has identified differences in the characteristics of patients with type 2 […]

Image credit: MdBabul | stock.adobe.com Kura Oncology’s ziftomenib has been granted Breakthrough Therapy Designation (BTD) by the FDA for heavily pretreated patients with relapsed/refractory (R/R) NPM1-mutant […]

Image credit: Pixel-Shot | stock.adobe.com Clinical trials are opportunities to advance how we diagnose, treat, and prevent disease, as well as to advance medicine and […]

Image credit: neirfy | stock.adobe.com A new report from the Centers for Disease Control and Prevention (CDC) demonstrates the efficacy of the original monovalent mRNA […]

ACT: How does the utilization of clinical outcome assessments (COAs) differ across the various therapeutic areas? Mooney: That’s a great question. I would say, in […]

Mike Hennessy Jr, president and CEO, MJH Life Sciences® While we continue to speed through the first half of 2024, it was not long ago […]

Image Credit: © Sergey Nivens – stock.adobe.com Generating insights from data based on structured patients’ reports dates back to 1980.1-3 At this time, researchers began […]

Marcelo Alves Favaro, Associate Outcomes Researcher, MAPI Research Trust Caprice Sassano, Research Lead – Applied Sciences, HumanFirst, an ICON company Roya Sherafat, MD, PhD, Scientific […]

Image credit: mi_viri | stock.adobe.com An analysis of eight randomized clinical trials (RCTs) found that the use of neoadjuvant platinum-based immune checkpoint inhibitors (ICIs) combined with […]

Dave Hanaman, President, Chief Commercial Officer, Co-Founder, Curavit Clinical Research. Japan’s digital health market is expected to show a compound annual growth rate (CAGR) of […]

Jill Sommerville, Senior Director Lauren Flood, Associate Director Matthew Ryan, Associate Director All with the digital and decentralized solutions for the PPD clinical research business […]

Image Credit: © Blue Planet Studio – stock.adobe.com A recent survey study published on JAMA Network Open sought to evaluate the current state and future […]

Vincent Keunen, Founder and CEO, Andaman7 New digital technologies are transforming possibilities in clinical research and driving a surge in real-world data (RWD) availability. This […]

Bruce Hellman, Chief Patient Officer and Co-Founder, uMotif You’re setting forth on a long journey; you have your bags packed, tickets in hand, and what […]

Todd Rudo, MD, Chief Medical Officer, Clario Luc Dekie, PhD, Director of Scientific Affairs, Cardiology, Clario In an era prioritizing personalized and patient-centric care, remote […]

Image Credit: © Shuo – stock.adobe.com A cross-sectional study recently published on JAMA Network Open analyzed the quality of responses from an artificial intelligence (AI) […]

Image Credit: © Egor – stock.adobe.com Reviva Pharmaceuticals has gained alignment from the FDA on its registrational Phase III program for brilaroxazine in schizophrenia. The […]

Image credit: David A Litman | stock.adobe.com Data from the Phase III STARGLO trial (NCT04408638) show the combination of Columvi (glofitamab; Roche) with gemcitabine and […]

Image Credit: © peshkova – © peshkova – stock.adobe.com The University of Minnesota (UMN) Masonic Cancer Center is expected to expand its ongoing investigator-initiated Phase […]

Image credit: Dr_Microbe | stock.adobe.com The combination of Krazati (adagrasib) plus cetuximab showed promise in patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer […]

Flo Mowlem, PhD, VP of Science, ObvioHealth On March 25, ObvioHealth hosted a webinar on the execution of a medical device clinical trial for migraine […]

Image credit: cendeced | stock.adobe.com An analysis of randomized, double-blind clinical trials found that psilocybin has a manageable adverse effect (AE) profile in the treatment of […]

April 5th 2024 Article Digital biomarkers, smartphones, and wearables are transforming clinical trials by revolutionizing remote data collection and providing insights into treatment efficacy. Learn […]

Meeting the first patient in (FPI) deadline is a critical milestone for study teams who must first implement various systems and processes as part of […]

Image credit: peterschreiber.media | stock.adobe.com Results from an interim analysis of an ongoing Phase III trial demonstrated the long-term safety and efficacy of AbbVie’s Qulipta […]

ACT: How important is it that a level of human intervention remains with the oversight of these artificial intelligence (AI) solutions? Stephen Pyke: It begins […]

Image credit: Kaikoro | stock.adobe.com With the recent advances in generative AI (GenAI) with large language models (LLMs), GenAI-enabled or augmented process improvement has garnered […]

ACT: How much of a game-changer are artificial intelligence (AI) solutions to patients participating in clinical research? What are some of the largest benefits they’ll […]

ACT: Could you describe the importance of collaboration, specifically through data sharing, with regards to advancing the development of technology solutions? Stephen Pyke: If the […]

Image credit: jarun011 | stock.adobe.com Pfizer’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine Abrysvo produced positive safety and efficacy in individuals aged 18 […]

Has the explosion of clinical trial technology made study execution too complex? For clinical research sites meeting and treating patients every day, the burden of […]