The U.S. Food and Drug Administration is announcing the availability of a draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials, making them more agile without compromising data integrity or participant protections.
The updates are intended to help pave the way for more efficient clinical trials 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 The draft guidance is adopted from the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline that was developed to enable the incorporation of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.
This draft guidance, once finalized, would update the existing guidance titled, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018). The revised draft recommendations are designed to be applicable to a broad range of clinical trials including those with innovative design elements. These elements have the potential to make trials more efficient and less burdensome. Additionally, the modernized GCP recommendations encourage the use of fit-for-purpose innovative digital health technologies (DHTs). DHTs, such as wearable sensors could potentially facilitate more agile data collection and assist with patient recruitment.
In addition to the recommendations supporting the modernization of trials, the principles outlined in the draft recommendations aim to make trials more efficient and potentially accelerate evidence generation for medical products by:
- Emphasizing the use of risk-based and proportionate approaches across the lifecycle of a clinical trial (e.g., data collection, monitoring, quality management). With this approach, investigators are encouraged to determine which data and clinical trial processes are most important to participant safety and data integrity, and focus efforts accordingly. This helps ensure investigators are allocating resources and efforts toward collecting and analyzing key data for the trial; and
- Encouraging sponsors to be proactive when it comes to a trial’s quality considerations. Quality considerations include attributes of a trial which are fundamental to the protection of participants, the reliability of trial results and the decisions made based on those trial results. Having an early focus on these factors helps ensure trials are designed efficiently, avoiding possible delays from unnecessary complexities and burdens.
As part of the FDA’s established process, this draft guidance will be open for public comment for 60 days. The ICH Expert Working Group will review and consider comments on this draft guidance, as well as feedback from other ICH member countries before finalizing the ICH guideline.