Date: Mon, 24 Jul 1995 15:14:38 +0500 From: awilson@smtpinet.aspensys.com (Wilson, Anne) Subject: FDA Meeting Notice FDA ANNOUNCES PUBLIC WORKSHOP AND ADVISORY SUBCOMMITTEE MEETING ON CURRENT ISSUES IN AIDS CLINICAL TRIALS The FDA is announcing a public workshop on current issues in HIV clinical trials. The workshop will be followed by a joint meeting of subcommittees of the Antiviral Drugs Advisory Committee and the National Task Force on AIDS Drug Development. Topic: The workshop will enable experts in the field of AIDS clinical trials, interested members of industry and the public to exchange ideas regarding clinical trials of drugs for the treatment of HIV. Subsequently, the advisory subcommittees will hear summary presentations from discussions held during the public workshop and discuss recommendations on the scientific design of future HIV clinical trials. Current federal regulations allow for the accelerated approval of drugs intended to treat serious and life-threatening diseases, including AIDS and HIV-related diseases, on the basis of changes in surrogate markers. The clinical efficacy of these products must then be supported by confirmatory trials that demonstrate therapeutic benefit by clinical endpoints. In HIV, the clinical endpoints that have been considered meaningful are survival and disease progression as manifested by the development of AIDS-defining opportunistic infections. One of the major challenges facing developers of HIV therapeutics is the successful design and conduct clinical confirmatory trials intended to provide the data needed to confirm the clinical benefit of drugs that have received accelerated approval. Study design issues include, but are certainly not limited to, choice of patient population, blinding, control groups, treatment modifications on study, analysis of heterogeneous endpoints, and other difficult issues. Study conduct issues include efficient recruitment of volunteers and retention of study subjects in trials long enough to gather sufficient endpoint data. These studies must be designed and conducted in the context of a rapidly changing world of new information and treatment strategies and increasing reliance on the use of surrogate markers to make treatment decisions. The goal of this workshop is to discuss the critical issues in the design and conduct of clinical confirmatory trials in HIV and to propose strategies to overcome identified obstacles so that new drugs can be made available more quickly and that information on how to best use them also be obtained without unnecessary delay. When and where: The public workshop will be held on Wednesday and Thursday, September 6 and 7, 1995, from 8:30 a.m. to 5 p.m. REGISTRATION for the workshop is required and must be received at fax number or Internet address below by August 18, 1995. The advisory committee meeting will be held on Friday, September 9, 1995, from 8:30 to 4:30 p.m.. The workshop and advisory committee meeting will be held in the William H. Natcher Conference Center, National Institutes of Health, 45 Center Drive, 2BC.02, Bethesda, MD, 20892. The entire three day series is open to the public. During the Advisory Committee meeting, there will be an open public hearing from 11 a.m. to noon; persons wishing to speak at that time should call a contact person by August 25. Who to call: Contact persons are Heidi Marchand or Kimberly Miles, telephone 301-443-0104. All those interested in attending the workshop on September 6 and 7 should FAX their registration to Dr. Marchand or Ms. Miles at 301-443-9216, including participant's name, organization name if any, address, and telephone number, or include this information in an Internet electronic message (with a return e-mail address for confirmation) to ZWANZIGE@FDACD.BITNET. (Note: A small number of Internet e-mail systems may be unable to send messages to this address). There is no registration fee for any part of this workshop, but advance registration is required. Interested parties are encouraged to register early because space may be limited. Comments: Interested persons may submit comments on the workshop until October 31, 1995, to the Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, or electronically send this information via Internet e-mail (with a return e-mail address for confirmation) to ZWANZIGE@FDACD.BITNET. (Note: A small number of Internet e-mail systems may be unable to send messages to this address). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number 95N-0226 Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.