When must all interventional clinical trials be registered according to the FDAA?

When must all interventional clinical trials be registered according to the FDAA?

• A. After enrollment
• B. Before enrollment
• C. Only if results are favorable
• D. At the time of publication

Answer: (B)

Interventional clinical trials must be registered before enrollment, as stipulated by the Food and Drug Administration Amendments Act (FDAA) of 2007. This requirement ensures transparency and accountability in the research process by allowing the public to access information about the trial before any participants are enrolled. Registering prior to participant involvement helps prevent issues such as selective reporting and publication bias, as it establishes a protocol that outlines the planned methods and objectives of the study. This pre-enrollment registration also enhances patient safety by informing potential participants about ongoing trials that might be relevant to their condition.

Interventional clinical trials must be registered before enrollment, as stipulated by the Food and Drug Administration Amendments Act (FDAA) of 2007. This requirement ensures transparency and accountability in the research process by allowing the public to access information about the trial before any participants are enrolled. Registering prior to participant involvement helps prevent issues such as selective reporting and publication bias, as it establishes a protocol that outlines the planned methods and objectives of the study. This pre-enrollment registration also enhances patient safety by informing potential participants about ongoing trials that might be relevant to their condition.