       Document 0596
 DOCN  M9610596
 TI    Clinical research and drug development of antivirals in HIV: an industry
       perspective.
 DT    9601
 AU    Carter SK; Worldwide Clinical Research and Development, Bristol-Myers;
       Squibb, Princeton, NJ 08543-4000, USA.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995;10 Suppl 2:S107-113.
       Unique Identifier : AIDSLINE MED/96033820
 AB    Clinical research can be viewed from three perspectives: research,
       patient care, and regulatory. Clinical research strategies can be either
       drug oriented, following the traditional phase I-II-III flow, or disease
       oriented. The drug-oriented strategy has as its goal regulatory
       approval, which means widespread patient-care usage. The
       disease-oriented strategy focuses on improving the overall care of the
       disease in question. At times, a dynamic tension exists between the two
       strategies. In HIV, as in all diseases, industry mainly is involved in
       drug-oriented studies emphasizing the regulatory perspective. In HIV a
       critical issue involves accelerated approval, following expanded access,
       based on surrogate markers. This initial approval is for end-stage
       therapy (the expanded access population). Additional claims require a
       full supplemental New Drug Application utilizing clinical end points.
       This leads to a situation in which the label, over time, becomes less
       relevant to how the drug is used in actual practice. This has caused
       concern among the patient advocates and is becoming a major challenge
       for the industry.
 DE    Antiviral Agents/*THERAPEUTIC USE  Biological Markers  Clinical Trials
       Drug Approval  *Drug Industry  Drug Labeling  Drug Therapy, Combination
       Human  HIV Infections/*DRUG THERAPY  *Research  United States  JOURNAL
       ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

