Waived Informed Consent in FDA/CBER Clinical Trials
*Renee Rees, CBER FDA 

Keywords: Informed Consent Study designs

In some clinical trials, it is only feasible to enroll subjects and administer the study treatment without first obtaining informed consent. In FDA/CBER, these trials tend to be trauma studies involving regulated blood products or components. The products may not necessarily be new blood products or components, but FDA still has the mandate to review the clinical trials. Due to the lack of the informed consent, study design, study conduct and statistical issues are held to a higher standard (21 CFR 50.24) during the regulatory review. This talk will discuss some of these issues that have come up in the review of these trauma studies. For example, since the trial may utilize rare blood products, the design should ensure the most efficient use of this resource. Cluster randomization may be necessary in order to best utilize emergency transportation. Primary endpoint selection must provide prospect of direct benefit (e.g., 30-day mortality versus 24-hour mortality). Sample size estimation becomes critical so that the trial maximizes potential to show benefit. Study execution should be structured to minimize missing data. Consideration for stopping the study early (for safety or futility) should be examined.