ICMJE Considering that clinical-trials registration is mandated by federal law and supported by a final-guidance document, a targeted
education program, and an easy-to-use Web-based data-entry tool, compliance has been mixed. While some companies voluntarily
provide information that far exceeds the criteria specified by the guidance, others provide only limited information or, in
some cases, none at all.
Participation in clinicaltrials.gov is voluntary, at least in the case of diseases that are not serious or life-threatening, and there is no congressional mandate
to provide trial results. At the moment, perhaps the strongest incentive for registration is the policy, adopted by members
of the International Committee of Medical Journal Editors in September 2004, stating that member publications would no longer
consider studies for publication unless the trials were registered at a publicly accessible site run by a not-for-profit.
At a minimum, Phase II to IV clinical trials must register the following information:
- unique trial number
- trial-registration date
- secondary IDs
- funding source(s)
- primary sponsor
- secondary sponsor
- responsible contact person
- research contact person
- title of the study
- official scientific title of the study
- research ethics review
- key inclusion/exclusion criteria
- study type
- anticipated trial start date
- target sample size
- recruitment status
- primary outcome
- key secondary outcomes
In order to comply with the ICMJE guidelines, trials starting after July 1, 2005 must be registered prior to or at the beginning
of patient enrollment. For trials that are currently underway or that started prior to July 1, 2005, registration was required
by September 13, 2005. These dates are consistent with the industry position issued by PhRMA in January.
Pharma Company Practices
In addition to government and industry-wide policies, many companies have unveiled more detailed plans to increase the amount
of clinical-trial information that is publicly available. With the possibility of regulatory mandates looming, certain industry
players are attempting to set acceptable standards. Eli Lilly, GlaxoSmithKline, AstraZeneca, Roche, and others have already
begun to post clinical-trial results on their corporate Web sites, generally following the basic formula laid out in the International
Conference on Harmonization (ICH3) guidelines. Merck, Pfizer, Genentech, and others have committed to posting information
on all hypothesis-testing Phase III and IV trials directly on
http://www.clinicaltrials.gov/, rather than on their corporate Web sites.
Eli Lilly has been a front runner in making both information about initiated clinical studies and study results publicly available.
The company officially launched its corporate registry site (
http://www.lillytrials.com/) in December 2004, and a link to this site is prominently featured on its corporate home page. Lilly boasts a registry with
results from more than ten years of clinical trials.