Lebowitz Barry D, Vitiello Benedetto, Norquist Grayson S
Adult and Geriatric Treatment and Preventive Intervention Research Branch, Division of Services and Intervention Research, National Institute of Mental Health, Bethesda, MD 20892-9635, USA.
Schizophr Bull. 2003;29(1):7-13. doi: 10.1093/oxfordjournals.schbul.a006992.
The Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) utilizes a variety of methodologies and approaches in the development of its clinical trials program. In this article, we describe the need for large multisite trials; the mechanisms for addressing this need; and the various approaches that have been used. In the course of carrying out this initiative, we have created opportunities for the Institute and its trial investigators to receive advice and input from the field. We describe the role and function of the trial coordinating center and NIMH staff. We identify the first steps to be taken in the initiation of a trial and highlight the opportunity for ancillary studies. Finally, we enumerate some of the pitfalls of large clinical trials and discuss measures taken to anticipate and address them.
美国国立精神卫生研究所（NIMH）的服务与干预研究部门在开展其临床试验项目时采用了多种方法和途径。在本文中，我们描述了大型多中心试验的必要性；满足这一需求的机制；以及所采用的各种方法。在实施这一举措的过程中，我们为该研究所及其试验研究人员创造了机会，使其能够从该领域获得建议和意见。我们描述了试验协调中心和NIMH工作人员的角色与职能。我们确定了启动一项试验时应采取的初步步骤，并强调了开展辅助研究的机会。最后，我们列举了大型临床试验的一些陷阱，并讨论了为预见和解决这些问题而采取的措施。
