FDA and the quality and integrity of research

FDA Consumer, Jan-Feb, 2002

The FDA has established an office to help ensure that research studies involving humans are conducted according to good clinical practice.

Good clinical practice (GCP) is a standard for the total research process: designing studies, conducting and monitoring them, recording data, analyzing results, and reporting and submitting these results to support product applications to the FDA.

The FDA's newly established office for good clinical practice (OGCP) requires that FDA-regulated medical research conform to the GCP standard. Compliance with this standard assures that the data and reported results are credible and accurate and that the rights, safety, and well-being of people in studies are protected. "Poor quality data has an impact on the accuracy of product labels and advertising that will be used by the public--and may lead to inappropriate decision-making on product approvals," says David Lepay, M.D., Ph.D., director of the OGCP. "Our office is out to ensure FDA's broad public protection role of high-quality decision-making on product approvals and labeling. We also want to protect subjects participating in clinical research that is critical to FDA decision-making."

To help make sure that the GCP standard is followed, the FDA conducts more than 1,000 inspections of clinical trials each year.

The OGCP, established in October and located within the office of the FDA commissioner, works closely with the FDA centers, the FDA's office of regulatory affairs, and the Department of Health and Human Services' office for human research protections. The OGCP staff also works with international colleagues to implement GCP standards globally.

If you have a question about the FDA's good clinical practice regulations and policy, call 301-827-4000 or 301827-3340.