FDA in early June 2023 released draft guidance with updated recommendations for good clinical practices (GCPs), with the goal of modernizing the design and conduct of clinical trials, to include the use of digital health technologies. The guidance, which will be available for review for 60 days on FDA’s website, is intended to update existing guidance from the International Council for Harmonization’s (ICH) recently updated guideline E6(R2) in March 2018. That draft guideline was developed to allow the incorporation of changing technological and methodological innovations into the clinical trial enterprise.
M. Khair EIZarrad, director of FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Medical Policy, led ICH Expert Working Group in developing the ICH E6(R3) guideline. Others contributing to the ICH draft were academic clinical trial experts from the ICH member countries. ICH group was formed to bring unifying, independent standards to the development of drugs and other products, as medical products began to be developed in different countries. According to the ICH website, its origins and progress were furthered also based on “tragedies, such as that with thalidomide in the 1960s.”
“A more robust trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients,” FDA Commissioner Robert Califf said in a release. “These draft recommendations propose a major step forward in this work.” Califf also said that “building quality into the design and conduct of trials and encouraging the use of innovative trial designs and health technologies are essential to truly advance clinical trials an generate meaningful results.”
The ICF now follows the guidance E6(R2) adopted in March 2018. The new guidance, once finalized and adopted, is expected to be applicable to “a broad range of clinical trials, including those with innovative design elements,” according to a news release from FDA. “These elements have the potential to make trials more efficient and less burdensome,” according to FDA. “Additionally, the modernized Good Clinical Practice (GCP) recommendations encourage the use of fit-for-purpose innovative digital health technologies.”
This latest draft of GCP, E6(R3), was issued within the context of other documents that complement the E6(R3) proposed guidance. In May 2023, FDA released draft guidance with recommendations pertaining to decentralized clinical trials toward the goal of guiding “the use of DHT-derived data in regulatory decision-making for drugs and biological products.” The goal of the DHT document was to potentially “accelerate” data and evidence generation for medical products in two ways. The first strategy would be to emphasize “risk-based and proportionate approaches across the lifecycle of a clinical trial.”
“With this approach, (clinical) investigators are encouraged to determine which data and clinical trial processes are most important to participant safety and data integrity, and focus efforts accordingly,” FDA said in its news release.
REFERENCE: MD+DI (Medical Device and Design Industry); 27 JUN 2023; Karen Young