HAZARDS OF DRUG EVALUATION : TRIALS OF 84 NON-APPROVED DRUGS
Abstract
1. If sufficient medical care is provided, compounds on which adequate animal toxicity studies have been done, do not appear to involve hazards in clinical trials. This conclusion is based on 93 drugs evaluated over a 4-year period in 1,704 patients; 84 of these drugs had not been approved by the Food and Drug Administration.
2. Other factors which tend to delay drug evaluation efforts include: the isolation of the chronically mentally ill from medical research centers, the lack of status associated with this type of research, the peculiarities of psychiatric practice and the source of the new compounds available for evaluation.
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