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.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
