Clinical Investigation Results Not Being Posted to ClinicalTrials.gov

By Heather Crawford and Evangeline Loh

Background on clinical evaluations

Many clinical trials are required to be registered on clinicaltrials.gov. Per U.S. legislation, trials that are required to be registered are those where the trial is interventional, is not a feasibility or Phase 1 trial, is intended to evaluate a product regulated by the FDA, and at least one of the following apply: has at least one site in the U.S., the trial is conducted under an FDA investigational device exemption (IDE) (or investigational new drug (IND), or the product is manufactured in and exported from the U.S. The EU requires registration and the clinical investigation report and summary in EUDAMED per the Medical Devices Regulation (MDR 2017/745). And in the absence of EUDAMED, the clinical investigation report and summary in the Communication and Information Resource Centre for Administrations, Businesses and Citizens (CIRCABC) directory. 

When performing clinical evaluations per the MDR, one of the data sources Emergo by UL leverages is clinical investigational information in ClinicalTrials.gov. We search the database for clinical investigations relevant to the device under evaluation. 

It has quite often been our experience that there will be information about a clinical investigation, a lapse of time, and then no results. There are also circumstances where through the systematic literature searches, we’ll identify an article published in a journal, though no results or reference to the publication are available in ClinicalTrials.gov. Likely, the rarest scenario, results are posted.

US FDA reminds sponsors and researchers  

After review of ClinicalTrials.gov, the US FDA contacted (March 30, 2026) more than 2,200 sponsors and researchers representing over 3,000 clinical investigations. This was to remind these entities that results of their clinical investigations did not appear to have been posted. In addition, sponsors and researchers were reminded that this was a legal requirement.

Both policy and law

The International Committee of Medical Journal Editors (ICMJE) Policy since 2004, and then formally in 2005, required clinical trial registration as a prerequisite for publication. Over 1,000 journals follow the ICMJE recommendations, and it had been our experience that many clinical investigations were posted because of the interest in publication. ICMJE does not require reporting results: this is to be dictated by the funding and regulatory agencies. 

In the U.S., the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), was issued in September 2016 and became effective January 18, 2017, in accordance with the U.S. Federal regulation implementing Food and Drug Administration Amendments Act (FDAAA) 801.  FDAAA requires clinical trials of drug, biological and device products except Phase 1 trials of drug/biological products and small device feasibility studies to register and submit results in ClinicalTrials.gov.

42 CFR Part 11 summary reminds us of the benefits

Advancing FDAAA of 2007, the summary of 42 CFR Part 11 when published as a final rule in the Federal Register (81 FR 64982) extols the benefits: “to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful and unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice and build public trust in clinical research.” 

Concluding remarks

While 42 CFR Part 11 has been law since January 2017, oftentimes, results of the clinical investigations have not been posted.

Emergo by UL experts are optimistic that this FDA reminder will increase the number of clinical investigation results posted to ClinicalTrials.gov. 

We remind manufacturers of their responsibility to report their clinical investigations and results in ClinicalTrials.gov.