The FDA has proposed a new rule that would require clincal trial organizers to include a statement in the informed consent documents, which are given to trial participants, informing them about registration, results and other information on the trial when it is submitted to www.ClinicalTrials.gov, a publicly available trial registry database.
The FDA Amendments Act of 2007 requires that the agency update its processes for certain clinical investigations, including a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank.
According to the FDA, knowledge of the existence of the clinical trial registry databank and of the fact that information about a particular clinical investigation may be included in the registry database could affect an individual’s decision to participate in a clinical trial.
“Knowledge of this information is equally important for potential participants in clinical drug trials and clinical device trials,” the agency said.
The total annual cost of the informed consent proposed rule is between $688,000 and $2.4 million, including between $473,000 and $1.7 million for the increased labor cost for administering the informed consent procedures for these medical professionals in applicable clinical trials, according to the FDA.
The FDA published the notice in the Dec. 29 Federal Register. Opportunity for public comment is open until March 1.