FDA's new age vision for clinical trials taking shape

The US Food and Drug Administration (FDA) has announced the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials.

Proposed modernizations seek to make practices more agile without compromising data integrity or participant protections, helping to pave the way for more efficient studies to facilitate the development of medical products.

The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of rapidly developing technological and methodological innovations into the clinical trial enterprise.