Over the past ten years, government agencies and the International Committee of Medical Journal Editors (ICMJE) have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinically directive trials are publicly available. The registration effort began with the development of a publicly available website: ClinicalTrials.gov. ClinicalTrials.gov is a service of the NIH, developed by the National Library of Medicine.
In 1997, the FDA/NIH began requiring registration for only a limited number of trials, then in September, 2007 the FDA Amendments Act (Title VIII. Sec. 801) significantly expanded the scope of clinical trials that must be registered and set civil monetary penalties for failing to register “applicable trials.”
In 2004, the ICMJE defined trials that must be registered in order to be considered for publication in journals that adhere to ICMJE standards.
In 2007, the ICMJE expanded the definition of trials that must be registered. Scores of journals (not limited to medical journals) have adopted the registration policy.
In 2016, the final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released, and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information was published.
The bottom line:
The FDA, NIH and the ICMJE each have their own requirements for registration, and while some of the requirements overlap, there are also significant differences. In order to comply with the law and preserve the ability to publish in many journals, both sets of requirements must be met.