The Current State Of ClinicalTrials.gov Results Reporting

The discovery of new and innovative treatments and therapies for human diseases is entirely dependent upon pharmaceutical industry-sponsored research and clinical trials. In turn, researchers rely on the successes and failures of previous studies, in order to determine where their efforts will be most impactful.

Peer-reviewed publications – most often medical journals – are the major source of current research in disease pathology and potential drug targets. In recent years, clinical trials registries – like ClinicalTrials.gov – have become an invaluable resource for researchers, clinicians and patients alike.

ClinicalTrials.gov was founded in 2000 as a web-based resource for information on both publicly and privately funded clinical trials. The site was created following the launch of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which required the National Institutes of Health (NIH) to establish a clinical trials registry. This database would contain vital information on all interventional studies involving human participants under US Food and Drug Administration (FDA) investigational new drug applications.

As of September 2007, all clinical trials testing the safety and efficacy of an investigational drug, biologic or medical device, are required to register on ClinicalTrials.gov. In addition, the principal investigator or sponsor company of a given interventional trial is required to report the results of the trial within 12 months of the completion date.

Aside from the legal obligations of clinical trial reporting, some groups have attempted to increase clinical trials registration by providing incentives. The International Committee of Medical Journal Editors (ICMJE) – a small group of journal editors that create standards for publication in medical journals – requires clinical trials to be registered with ClinicalTrials.gov before any research can be published in their affiliated journals.

Interestingly, the ICMJE does not require study investigators to report clinical trials results in the registry prior to publication. The NIH also lists a variety of benefits to clinical trial registration and results reporting, aimed at educating sponsor companies on the value of mandatory results reporting. According to the NIH, clinical trial registration on ClinicalTrials.gov:

• Satisfies ethical commitments made to clinical trial participants.
• Increases understanding of trial design for prospective participants and their physicians.
• Reduces publication bias by providing a platform for indeterminate – or so-called ‘negative’ – results.
• Helps funding bodies determine where to best invest research funds.
• Aids institutional review boards (IRB) in assessing the ethics of a study.