ClinicalTrials.gov regulatory outlook
This article was originally published in The Gray Sheet
Executive Summary
National Institutes of Health plans by June 2009 to propose new regulations for registering clinical trials in the ClinicalTrials.gov registry, according to an announcement in the government's fall 2008 Unified Agenda, issued Nov. 24. The regs, which will apply to both device and drug trials, will specify registration procedures and define the information that sponsors or principal investigators must provide. Beverly Lorell, senior medical and policy advisor at the law firm King & Spalding, speculates that the rule will simply formalize the registration policies already in place (1"The Gray Sheet" Sept. 29, 2008, p. 8). In a separate rulemaking, NIH is expected to propose how to handle adverse events in the registry. The FDA Amendments Act requires NIH to finalize an adverse events rule by March 2009; if the rule isn't promulgated by then, the act states, default requirements for adverse event posting will go into effect