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临床试验中的行为不端不仅仅是学术腐败,它使得临床试验的受试者安全受到威胁,临床试验的过程失去可信度;使得申办者提交数据的有效性和公正性大打折扣,失去公信力。美国食品和药物管理局对临床试验中的欺诈行为实施零容忍,研究者将面临取消研究资格和执业资格,甚至涉及罚款、监禁和法律诉讼。必须对药物临床试验中的行为不端,采取积极预防措施,实施严厉行政监管。
Misconduct in clinical trials is not only academic corruption, which makes the safety of subjects in clinical trials threatened and the process of clinical trials lose credibility. The effectiveness and fairness of data submitted by sponsors are greatly reduced, thus losing credibility . The U.S. Food and Drug Administration has zero tolerance for fraud in clinical trials, and researchers face the disqualification and eligibility of research, even to fines, imprisonment and legal proceedings. Must be drug misdemeanors in clinical trials, take proactive preventive measures, the implementation of strict administrative supervision.