Updates to GCP and US Government Policies for Clinical Trial Patients

Much needed major updates to the GCP guidance and the Common Rule were proposed by the FDA and DHHS recently. These changes are being proposed to modernize the regulatory requirements to match the current practices for clinical trials. In one of the most comprehensive updates to the human subject protection rules that apply to clinical trials funded by the US government in almost 25 years, 16 agencies of the US government jointly published notice to amend the Federal Policy for Protection of Human Subjects. The law was created in early 1974 and final adopted in 1991 to create a uniform body of regulations across all Federal departments and agencies, and called the “Common Rule”. This law has been the basis of informed consent process, IRB review, design of studies, analysis of data, and privacy of information for all federally funded clinical research since 1991. The law is being updated to improve the informed consent process, increase transparency to trial participants, update the definition of IRB-exempt and IRB-review-required studies, update the IRB review process to increase its efficiency and define all the clinical trials that are subject to the Common Rule. The US government funds hundreds of clinical trials, directly by being the sponsor or indirectly by giving grants. In either case, the clinical trial must comply with the Common Rule. This week, the DHHS announced that it would hold a public meeting on 20 Oct to discuss the updates and collect public comments on the same. Similar to the Common Rule, ICH E6 guidance, the core guidance document for GCP was released in 1996 and has not been updated in almost 20 years. The last revision to this guidance was in June 1996, more than 19 years ago. About 26 revisions were made to the original GCP guidance to address the complexity, technology and risk management of modern clinical trials. Major additions include requirement of certified copies when an electronic copy is made of a document, requiring formal clinical monitoring plans and reports, validation of computer systems, making clinical investigators responsible for supervising their staff and all study documents, risk management practices, requiring SOPs for clinical sites, risk-based monitoring, auditing, CAPA and good documentation practices. Almost all the updates proposed are already a part of good clinical practices (GCP) and are followed by FDA-regulated clinical trials. So, it should come as no surprise that the government wants to create similar practices for non-FDA-regulated government-funded research.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research

Expert Opinion: Mukesh Kumar VP, RA, Amarex Clinical Research