Clinical Trial Registries

In November of 1997, Congress included a provision of the Food and Drug Administration Modernization Act to mandate that the National Institutes of Health (NIH) establish, maintain, and operate a public resource for information on efficacy studies of drugs (including biological drug products) to treat serious or life-threatening diseases and conditions conducted under FDA’s investigational new drug and device regulations (21 CFR Parts 312 and 812). The NIH, through the National Library of Medicine, with input from the FDA and other agencies, developed this database called This database was originally developed for serious or life-threatening diseases, but also accepts other federally and privately supported research studies. The database provides the public with information about the trial’s purpose, who may participate, locations, and phone numbers for more details.

Although this database currently includes only a small percentage of trials, it is the only existing registry that currently fulfills the criteria for acceptable registries specified by the International Committee of Medical Journal Editors (ICMJE). With the goal of further developing and fostering a publicly available database of all clinical trials, the ICMJE mandated that all clinical trials beginning subject enrollment on or after July 1, 2005, must be registered prior to the enrollment of the first subject. Journal editors will not consider the trial for publication if this has not occurred. Ongoing trials will need to be registered before September 13, 2005. The definition of clinical trials for the purpose of this registry is as follows: “Any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”

While the commercial clinical trials registry, Center Watch requires proof of IRB approval for registration, does not. The Fair Access to Clinical Trials Act proposes to mandate that clinical trials be registered prior to IRB approval. However, this Act, which was introduced to Congress in 2004, 2005 and again in 2006, has not yet been passed.