[Federal Register Volume 60, Number 149 (Thursday, August 3, 1995)]
[Notices]
[Pages 39758-39759]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19087]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0226]


Current Issues in AIDS Clinical Trials; Notice of a Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of a public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop on current issues in acquired immune deficiency syndrome 
(AIDS) 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, announced elsewhere 
in this issue of the Federal Register. The workshop will enable experts 
in the field of AIDS clinical trials, interested representatives of 
industry, and interested members of the public to exchange ideas 
regarding clinical trials of drugs for the treatment of AIDS. While the 
workshop is not intended to result in consensus among participants or 
to contribute to the formulation of agency policy, discussions 
regarding current issues in AIDS clinical trials may provide assistance 
to pharmaceutical sponsors in designing appropriate study protocols and 
expediting drug development.

DATES: 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 must be 
received by August 18, 1995.

ADDRESSES: The public workshop will be held at the National Institutes 
of Health, William H. Natcher Conference Center, 45 Center Dr., 2BC-02, 
Bethesda, MD. Written comments may be submitted at any time to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857. A transcript and summary 
of the workshop will be available from the Docket Management Branch 
(address above) and from the Freedom of Information Office (HFI-35), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Heidi C. Marchand or Kimberley M. 
Miles, Office of AIDS and Special Health Issues (HF-12), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-0104. 
Persons interested in attending this meeting should FAX their 
registration to one of the individuals named above at 301-443-9216, 
including the participant's name; organization name, if any; address; 
and telephone number. 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 is limited.

SUPPLEMENTARY INFORMATION:
    Current Federal regulations allow for the accelerated approval of 
drugs intended to treat serious and life-threatening diseases, 
including AIDS and human immunodeficiency virus (HIV)-related diseases, 
on the basis of clinical trials showing that the drugs have an effect 
on surrogate endpoints. Following approval, FDA may require that the 
drug applicant study the drug further to verify the clinical efficacy 
of the product by performing clinical trials designed to demonstrate 
therapeutic benefit by clinical endpoints. In AIDS, 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 of the clinical 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 not limited to, choice of patient population, control groups, 
treatment modifications on study, and analysis of heterogeneous 
endpoints. Study conduct issues include efficient recruitment of 
volunteers and retention of study subjects in trials long enough to 
gather sufficient endpoint data. These studies are being 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 critical issues in the 
conduct of clinical trials in HIV in accelerated approval matters and 
to suggest strategies to overcome identified obstacles so that new 
drugs and information on the best use of these new drugs can be made 
available more quickly.
    A transcript and summary of the workshop will be available from the 
Freedom of Information Office (address above) approximately 10 business 
days after the workshop at a cost of 10 cents per page.
    Interested persons may submit, at any time, to the Dockets 
Management Branch (address above) comments on the workshop. 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 found in 
brackets in the 

[[Page 39759]]
heading of this document. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.
    To permit time for all interested persons to submit data, 
information, or views on this subject, the administrative record of the 
workshop will remain open until October 31, 1995. Persons who wish to 
provide additional materials for consideration should file these 
materials with the Dockets Management Branch (address above) by October 
31, 1995.

    Dated: July 28, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-19087 Filed 8-2-95; 8:45 am]
BILLING CODE 4160-01-F