Click the title above to open the Applied Clinical Trials February/March 2017 issue in an interactive PDF format.
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
VYNE Ends Phase IIb Vitiligo Trial of Repibresib After Missing Primary Endpoint
July 30th 2025VYNE Therapeutics will terminate its Phase IIb trial of topical Repibresib gel in nonsegmental vitiligo after failing to meet F-VASI50 and F-VASI75 endpoints at week 24, despite nominally significant improvements in other secondary and exploratory measures.
ACT Brief Episode 1: Placebos, Politics, and the Ethics of Vaccine Trials
July 31st 2025In this pilot episode of the Applied Clinical Trials Brief, we examine the renewed push for placebo-controlled vaccine trials in the US, why experts warn it violates core ethical standards, and how these proposals could jeopardize both participant safety and future innovation.
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.
J&J Submits sBLA to FDA for Tremfya Label Expansion Based on PsA Joint Damage Inhibition Data
July 29th 2025The submission is supported by Phase IIIb APEX trial results showing Tremfya reduced symptoms and inhibited structural progression in biologic-naïve patients with active psoriatic arthritis.