The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.
On March 14, 2019, FDA published guidance intended to help with the development of enrichment strategies used in clinical investigations to demonstrate the effectiveness of drug and biological products. The guidance focuses on improving the ability of a study to detect a drug’s effectiveness, but similar strategies can be used in safety strategies.
The guidance defines enrichment as “the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population.” The document discusses precision medicine and the interpretation of studies. Specifically, the guidance addresses decreasing variability, identifying high-risk patients and more responsive patients, and regulatory issues.
Source: FDA
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.