FDA Clinical Trials Endpoints Project

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ASCO-FDA Project on Cancer Drug Approval Endpoints

FDA Clinical Trials Endpoints Project

In May 2007, the Food and Drug Administration (FDA) issued a final Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.

This guidance was designed to address regulatory principles for efficacy studies and how they have influenced endpoint selection for approval of cancer drugs. In addition, the FDA has undertaken an ongoing project to identify and evaluate potential endpoints in the most common cancers.

A steering committee, including representation from the FDA, the National Cancer Institute (NCI), the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), and the American Society of Hematology (ASH), guides the conduct of public workshops focusing on these important issues.

The workshops bring together leading oncologists and hematologists, as well as statisticians, industry representatives, and patient advocates, to discuss endpoints that are suitable for demonstrating the clinical benefit of cancer drugs. Summary information from the workshops is presented to the Oncologic Drugs Advisory Committee (ODAC), which provides recommendations to the FDA.

The agency plans to issue guidance documents regarding clinical endpoints for specific cancer types To date, endpoints workshops have been conducted for:

lung cancer,
colorectal cancer,
prostate cancer,
acute leukemia,
brain cancer,
ovarian cancer and
multiple myeloma.

Future topics may include low-grade lymphoma, renal cell carcinoma, melanoma, pancreatic cancer, or breast cancer.

For an investigational drug to obtain FDA approval, efficacy must be demonstrated in clinical trials based on endpoints that lead to regular drug approval or surrogate endpoints leading to accelerated drug approval.

Potential oncology endpoints include survival, tumor response, response duration, relief of symptoms, or composite clinical benefit endpoints.

ASCO’s mission includes the goals of ensuring patient access to high-quality cancer care and supporting increased clinical research. It is expected that improvements in cancer research including development of more patient-oriented endpoints, will result from the endpoints workshops.

Investigators and sponsors will be able to benefit from scientific input provided at the meetings and subsequently design protocols that optimally use endpoints to produce drugs that are safe and effective.