Registering clinical trials
Registering clinical trials
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DOI：
10.1001/jama.290.4.516
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发表时间：
2003-07-23
影响因子：
120.7
通讯作者：
Rennie, D
中科院分区：
文献类型：
--
作者：
Dickersin, K;Rennie, D
不可能找到所有已启动的临床试验的信息，这一点引起了国际社会的关注。这是一个特别令人担忧的问题，因为科学家倾向于更频繁地发表积极的发现而不是消极的发现（发表偏见）。已启动的临床试验的综合登记册（每个试验都分配有唯一的标识符）将告知审稿人、医生和其他人（例如消费者）哪些试验已启动，并直接解决发表偏倚问题。患者及其临床医生还可以知道哪些试验可供招募，从而加快医学进步。参与临床试验的个人通常会表示同意，因为他们相信自己正在为医学知识做出贡献。但如果从未报告所获得的知识，患者与研究人员之间以及患者与研究伦理审查委员会之间的信任都会受到损害。如果工业界从公众参与试验中获得经济利益，但拒绝通过公开工业界赞助的试验信息来回报，那么道德问题就尤其值得关注。所有利益相关者——研究者、研究组织和机构、期刊编辑、立法者、消费者和其他人——必须立即在各自领域共同采取行动，以确保临床试验的全面注册。
That it is not possible to find information about all initiated clinical trials is of international concern. This is a particular worry because scientists tend to publish their positive findings more often than their negative findings (publication bias). A comprehensive register of initiated clinical trials, with each trial assigned a unique identifier, would inform reviewers, physicians, and others (eg, consumers) about which trials had been started and directly address the problem of publication bias. Patients and their clinicians could also know which trials are open for enrollment, thus speeding medical advances. Individuals who participate in clinical trials typically provide consent in the belief that they are contributing to medical knowledge. But if the knowledge gained is never reported, the trust between patients and investigators and that between patients and research ethics review boards are both damaged. Ethical issues are of particular concern if industry is gaining financially from public involvement in trials, but refusing to reciprocate by making information from industry-sponsored trials generally available. All stakeholders-investigators, research organizations and institutions, journal editors, lawmakers, consumers, and others-must act now, together and in their own domains, to ensure comprehensive registration of clinical trials.