FDA Announced Additional Steps to Modernize Clinical Trials

On June 06, 2023, the U.S. Food & Drug Administration announced a new draft guidance with updated recommendations for clinical trials. The updates included in the new draft guidance would be applicable to good clinical practices (GCPs) and are intended to modernize the design and conduct of clinical trials. The updates are geared toward efficiency to facilitate the development of drug and medical products.

The draft guidance is aligned with the International Council for Harmonisation’s (ICH) recently updated E6(R3) draft guideline.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

Proposed Updates in the Draft Guidance

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.