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Clinical Trial Registration: Looking Back and Moving Ahead

Authors
Publisher
Medicinska naklada; [email protected]
Publication Date
Disciplines
  • Design
  • Medicine
  • Political Science

Abstract

In 2005, the International Committee of Medi- cal Journal Editors (ICMJE) initiated a policy re- quiring investigators to deposit information about trial design into an accepted clinical trials registry before the onset of patient enrollment (1). This policy aimed to ensure that information about the existence and design of clinically directive trials was publicly available, an ideal that leaders in evi- dence-based medicine have advocated for decades (2). The policy precipitated much angst among re- search investigators and sponsors, who feared that registration would be burdensome and would sti- fle competition. Yet, the response to this policy has been overwhelming. The ICMJE promised to re- evaluate the policy in 2 years after implementation. Here, we summarize that reevaluation, specifically commenting on registries that meet the policy re- quirements, the types of studies that require reg- istration, and the registration of trial results. As is always the case, the ICMJE establishes policy only for the 12 member journals (a detailed description of the ICMJE and its purpose is available at www. icmje.org), but many other journals have adopted our initial trial registration recommendations, and we hope that they will also adopt the modifications discussed in this update. The research community has embraced tri- al registration. Before the ICMJE policy, Clinical- Trials.gov, the largest trial registry at the time, con- tained 13 153 trials; this number climbed to 22 714 one month after the policy went into effect (3). In April 2007, the registry contained over 40 000 tri- als, with more than 200 new trial registrations oc- curring weekly (Zarin D, personal communica- tion). The 4 other registries that meet the ICMJE criteria have also grown as scores of journals have adopted the ICMJE clinical trials registration pol- icy. In response to burgeoning registration, many investigators, sponsors, and government agen- cies have asked the ICMJE to recognize their local re

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