Document 0563
 DOCN  M9590563
 TI    Registration of drugs for treating cancer and HIV infection: a plea to
       carry out phase 3 trials before admission to the market.
 DT    9509
 AU    Koopmans PP; Department of Medicine, University Hospital Nijmegen,;
       Netherlands.
 SO    BMJ. 1995 May 20;310(6990):1305-6. Unique Identifier : AIDSLINE
       MED/95291039
 AB    Drugs for cancer and HIV infection tend to be admitted to the market on
       the basis of results from phase 2 trials. Assessing the benefit-risk
       balance with phase 2 trials often is difficult--the effect of the drug
       is usually temporary; the correlation between response or improvement of
       clinical measurements and the patient's wellbeing is often poor; and the
       side effects of drugs for these fatal diseases are serious. Therefore,
       although sometimes difficult to conduct, comparative trials that use
       standard treatment, placebos, or best supportive care remain the
       cornerstone for reliably assessing the benefit-risk balance.
 DE    Acquired Immunodeficiency Syndrome/DRUG THERAPY  *Antineoplastic Agents
       *Antiviral Agents  *Clinical Trials, Phase III  Drug and Narcotic
       Control  *Drug Approval  Human  Placebos  Risk Assessment  Treatment
       Outcome  JOURNAL ARTICLE

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