FDA Audits and Protocol Complexity
Applied Clinical Trials
The number of site audits performed has grown significantly.
An increasing amount of public data on clinical trial research has become available, including ClinicalTrials.gov and Open Payments. In addition, Europe has developed equivalent databases, or is in the process of developing them. The FDA has made its global site audit results available for some time to the public. The number of audits increased substantially, growing from 1,185 in 2008 to 10,264 in 2013, the last full year available. The summary results do indicate that up to 2010, the FDA increased the number of audits outside the U.S. However, since 2011, the percentage of sites audited outside the U.S. has remained stable at 26% to 28%.
The FDA reports results in three categories: no action indicated (NAI), official action indicated (OAI), and voluntary action indicated (VAI). Since 2008, there has been virtually no change in the audit results.
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.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.
