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FDA clinical trial endpoints guidance

This guidance is intended to assist sponsors in the clinical development of drugs for the treatment of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the Agency's current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products. It is also intended to serve as a focus for continued discussions among the Division of Antiviral Drug Products (DAVDP), pharmaceutical sponsors, the academic community, and the public.

The draft version of this document, first posted in August 1999, was based on a DAVDP advisory committee meeting, convened in July 1997, to discuss the use of HIV RNA endpoints for traditional approval of antiretroviral drugs. This document has been updated to address public comments to the draft version and to include pertinent information from a DAVDP advisory committee meeting, convened in January 2001, to address issues relating to trial design in heavily treatment experienced HIV-infected patients.

This guidance does not address specific phase-1 and phase-2 development issues, development of alternate dosing regimens, or the use of HIV-1 resistance testing. These issues will be addressed separately in future guidance documents.

In addition to consulting guidance documents, sponsors are encouraged to contact the division to discuss specific issues that arise during the development of an antiretroviral drug product.

BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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