Table 2.
Scope of key policies for clinical trial reporting to ClinicalTrials.gov*
| Policy (effective date) | Scope/requirements | |
|---|---|---|
| Registration | Results reporting | |
| Food and Drugs Administration Modernization Act (21 November 1997; ClinicalTrials.gov registry available starting on 29 February 2000) | Clinical trials of investigational new drugs for serious or life threatening conditions and diseases | N/A |
| International Committee of Medical Journal Editors8† (1 July 2005 for newly initiated trials; 13 September 2005 for ongoing trials) | All clinical trials as a condition for consideration of publication of results | As of December 2017: expected for clinical trials subject to the results reporting requirements of relevant funding and regulatory agencies, and encouraged for all other interventional studies.9 |
| Food and Drugs Administration Amendments Act (FDAAA)10 (27 September 2007) | Non-phase 1 clinical trials of FDA regulated drug and biological products, and non-feasibility trials of FDA regulated device products | Non-phase 1 clinical trials of FDA approved/licensed drug and biological products, and non-feasibility trials of FDA cleared/approved device products |
| Final rule implementing FDAAA in Title 42, Part 11 of the Code of Federal Regulations (42 CFR Part 11) 11 (18 January 2017) | Non-phase 1 clinical trials of FDA regulated drug and biological products, and non-feasibility trials of FDA regulated device products | Non-phase 1 clinical trials of FDA regulated drug and biological products, and non-feasibility trials of FDA regulated device products, whether or not FDA approved, cleared, or licensed |
| NIH policy on the dissemination of NIH funded clinical trial information12 (18 January 2017) | Clinical trials funded by the NIH | Clinical trials funded by the NIH |
N/A=not applicable; NIH=National Institutes of Health.
*
For a more complete listing, see table in Selected Trial Registration Laws and Policies (https://clinicaltrials.gov/ct2/manage-recs/background#WhyRegister).
†
Requires registration at ClinicalTrials.gov, or one of the primary registries on the WHO International Clinical Trials Registry Platform (http://www.who.int/ictrp/network/primary/en/).