PROs and Drug Labeling Undergo Scrutiny
In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.
In a Monday morning session entitled "Patient-Reported Outcome Instruments: Overview and Comments on the FDA Guidance," CDER officials stressed the importance of including PROs early in the clinical trial planning process, rather than at data analysis stages. Edwin P. Rock, MD, PhD, medical officer, division of drug oncology products, described the endpoint model/conceptual framework that organizes the amount/type of data for various uses.
"This approach provides clarity for FDA as well as the sponsor in terms of benefit and feasibility of labeling goals." John H. Powers, MD, FACP, lead medical officer, office of antimicrobial products, said "This is an exciting time to develop novel ways to find drugs to benefit patients." However, he cautioned that clinical researchers must be careful to measure what they think they are measuring in a valid and precise way.
And addressing the issue of multiple endpoints, Robert T. O'Neill, PhD, director, office of biostatistics, said this is an issue FDA is currently examining in the context of the Critical Path Initiative. He also said the issue of Minimum Important Differences and their inclusion in PROs is a hot topic that also warrants further analysis.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin 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 diverse patient populations, personalized treatment methods, recruitment strategies, and more.
New Data Emerges from Phase IIb RELIEVE UCCD Study in Ulcerative Colitis and Crohn’s Disease
February 25th 2025Following initial positive results shared by Teva and Sanofi in December 2024, new data shows duvakitug (TEV’574/SAR447189) achieved higher rates of clinical remission compared to placebo in the advanced therapy-experienced subgroup.
