临床试验研究中的伦理学与循证医学

随着生物医学的发展,有关临床医学研究的伦理问题已成为国际关注的焦点之一.临床医学试验中人类受试者的权利和利益必须得到尊重和保护.为此,国际国内已制定相应的伦理准则,其中独立的伦理委员会审查及受试者知情同意书的签署是人类研究受试者权利的福利和保障.临床试验是否符合伦理原则,首先决定于研究证据是否真实可靠.从随机对照试验中获取的证据具有最强的真实性和可靠性,其设计目的和优点能使对研究结果有影响的各种因素在各组之间等同化,从而保证受试者利益与风险的公正分配,并能有效阻止无效治疗的滥用和肯定有效治疗的价值.系统评价能为临床决策者或为未来决策提供证据.循证医学特别重视人体的整体状态、终点指标和卫生经济学指标评价,并十分注意证据的不断更新,提供更真实可靠的研究证据.随着循证医学的兴起,对临床试验的要求越来越高,其中所涉及到的医学伦理问题将愈显突出.

Evidence-based Medicine Guides the Performance of Ethics in Clinical Trials

In the clinical trials, the rights and interests of participants must be considered. Ethical principles including the Declaration of Helsinki for clinical research have been established, and the institutional review board (IRB) and informed consent are important for protecting the rights and interests of participants. Whether a clinical trial is in accordence with the ethics depends on if the available clinical evidence is valuable and credible. The better candomize controlled trial (RCT) is one of the best evidence which will make different results equal between the treatment group and the controlled group. Thus benefits and risks of participants are allocated equitably and useless treatment is prohibited when the effective treatment affirmed at the same time. Economic health evaluation and outcome measurements are emphasized in EBM, and the clinical evidence is updated regularly. It is EBM and its emphasis of evidence that need the high-quality clinical trials, therefore the problems of ethics involved in clinical trials is important.