The evaluation of new drugs. Current Food and drug Administration regulations and statistical aspects of clinical trials

Abstract

Several thousands of new drugs are tested in man each year. The availability of patients suffering with diseases for which the new drug might be effective and in whom such test drugs may be appropriately tried is a limiting factor in the evaluation of new drugs. The availability of medical and scientific personnel skilled in procedures employed in clinical trials is another major limiting factor in drug evaluation. An attempt must be made to develop these skills in medical investigators and practicing physicians who participate in the testing of new drugs, to assure that the methods used in clinical evaluation will result in the release of drugs which are safe and effective.