Harmonization of Clinical Trial Rules for Private and Public Funded Clinical Trials    

For the last few years, rules governing clinical trials funded by government grants are being harmonized with the rules for privately funded trials. Most of the government funded trials have traditionally required additional burdensome processes that limited their patient access without additional subject protection or other benefits. The rules changes were designed to address those concerns. There should be fewer differences in the regulatory requirements for all clinical trials independent of the funding source. The US government is the biggest funding source in the world for clinical trials in new technologies, new inventions, and indications with uncertain early commercial potential. Clinical trial funded by grants from the US Federal government need to follow 45 CFR 46, known as the Common Rule enforced directly by the Department of Health and Human Services (HHS), in addition to the 21 CFR 312 enforced by the FDA. The biggest difference in the two requirements is for the IRB review. Older rules required, trials under 21 CFR 45 to have multiple IRBs reviewing the protocol. The new rules require using a single IRB for multi-site trials. The second major change is regarding the IRB review process and the informed consent. These include allowing electronic signature for informed consent, rearranging content on the informed consent such that the purpose and relevance of the trial to the participants is described earlier in the informed consent, and many other significant changes to the IRB and informed consent processes. These changes will apply to all clinical research and should clarify the intent of the regulation which is to encourage clinical trial participation and reduced documentation burden while maintaining protection of subjects who chose to participate in clinical trials. These changes are currently in the proposed rule stage, meaning it could be a year or more before they become legally effective but many of these changes can be easily incorporated in the new trials being planned with an expectation of a favorable FDA review.