Registration of Drugs for Treating Cancer and HIV Infection: A Plea to Carry Out Phase 3 Trials Before Admission to the Market
BMJ (British Medical Journal). 1995 May 20; 310(6990): 1305-1306.
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.
Aids; Cancer; Drugs; Government; Government Regulation; HIV Seropositivity; Human Experimentation; Investigational Drugs; Life; Placebos; Prolongation of Life; Quality of Life; Random Selection; Regulation; Research; Research Design; Risk; Risks and Benefits; Terminally Ill; Therapeutic Research; Toxicity;
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Decision-Making Process in Patients Before Entering Phase III Cancer Clinical Trials: A Pilot Study Huizinga, Gea A.; Sleijfer, Dirk Th.; van de Wiel, Harry B.M.; van der Graaf, Winette T.A. (1999-04)The present study was performed to gain insight into the decision-making process that patients go through when asked to participate in a cancer clinical trial. Fourteen cancer patients entered a pilot study concerning ...