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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
