EVALUATION OF NEW DRUGS - CURRENT FOOD AND DRUG ADMINISTRATION REGULATIONS AND STATISTICAL ASPECTS OF CLINICAL TRIALS
EVALUATION OF NEW DRUGS - CURRENT FOOD AND DRUG ADMINISTRATION REGULATIONS AND STATISTICAL ASPECTS OF CLINICAL TRIALS
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DOI：
10.1001/archinte.119.6.547
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发表时间：
1967-01-01
影响因子：
--
通讯作者：
BUKANTZ, SC
中科院分区：
文献类型：
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作者：
BARRON, BA;BUKANTZ, SC
每年有数千种新药在人体上进行试验。新药可能有效的疾病患者的可用性以及此类试验药物可能适当试用的患者的可用性是评价新药的一个限制因素。在临床试验中使用的程序熟练的医疗和科学人员的可用性是药物评价的另一个主要限制因素。必须努力培养参与新药试验的医学研究者和执业医师的这些技能，以确保临床评价中使用的方法将导致安全有效的药物发布。
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.