美国食品和药物管理局对临床试验中学术行为不端的监管

Supervision and management of United States Food and Drug Administration to fraud/misconduct in clinical trials

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。

The misconduct in clinical trials is more than academic corruption, which places all subjects in that trial at possible safety risks and makes the process of clinical trials lost credibility. The misconduct in clinical trials jeopardizes the validity and impartiality of submitted or published data by the sponsor and undermines the agency＇ s mission to protect and promote the public health. FDA adopts a zero-tolerance policy and also makes the investigators disqualifications or cancellation study eligibility, revocation of doctor＇ s license, even face fines, criminal prosecutions and imprisonment. To avoid the misconduct, the whole process of clinical trials should be taken precautions and strictly supervised.