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Concerns have grown tremendously in recent years regarding noncompliance in clinical trial reporting. Shockingly, the National Institutes of Health (NIH) failed to disclose the results of over one-third of the clinical trials it sponsored, according to a 2022 Office of Inspector General <a href="https://oig.hhs.gov/oas/reports/region6/62107000.pdf">report</a>. Lack of transparency in clinical trials not only harms the integrity of the scientific process but also can result in civil or criminal penalties and impact grant funding.

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Universities and academic medical centers, which often conduct research as sponsor-investigators, are among the worst offenders in failure to report data from clinical trials, most of which are federally funded. This failure to report poses a great risk of conflicts of interest and can contribute to undermining public trust in the pharmaceutical industry. Advocacy groups have encouraged greater implementation – and enforcement – of strict regulations to ensure that universities and other organizations are held accountable for their reporting requirements, but more efforts may be needed.

ClinicalTrials.gov is an online database that serves as a repository for information about clinical research studies conducted domestically and all over the world. The National Library of Medicine created this database with the intention of providing a transparent, publicly accessible source of information; it aims to encourage practitioners, patients and researchers to make independent and informed decisions.

In 2007, <a>the Food and Drug Administration Amendments Act </a>(FDAAA) was passed; it mandates that certain clinical trials, known as Applicable Clinical Trials (ACTs), register and report their results on ClinicalTrials.gov. Clinical trials that must be reported are controlled clinical investigations (other than phase 1 investigations) of any FDA-regulated drug or biological product for any disease or condition. <a>ACTs generally include interventional studies </a>(with one or more arms) of FDA-regulated drug, biological or device products when 1) the trial has one or more sites in the United States, 2) the trial is conducted under an FDA investigational new-drug application or investigational device exemption, or 3) the trial involves a drug, biological or device product that is manufactured in the United States or its territories and is exported for research. The primary responsibility for registering trials and reporting results rests with the trial sponsors, but principal investigators can also bear the burden of reporting results. Clinical trial registration and reporting requirements are further clarified in an NIH, Department of Health and Human Services, <a href="https://www.govinfo.gov/content/pkg/FR-2016-09-21/pdf/2016-22129.pdf">final rule</a>.

Should the sponsor of a trial fail to comply with requirements, the FDAAA imposes severe consequences. Penalties can include fines, suspension or termination of federal funding, and, in severe cases, legal action by the Department of Justice. Violation of the FDAAA’s reporting requirements may result in civil monetary penalties of up to $10,000 per day for each violation, with a maximum penalty of $1 million. Moreover, failure to comply with FDAAA requirements could result in future funding being withheld from the sponsor’s institution and complete exclusion of the sponsor-institution or sponsor-investigator from participation in federally funded research.

The FDAAA establishes clear timelines for the registration and results reporting of clinical trials. Trials must be registered on ClinicalTrials.gov within 21 days of enrolling the first participant. Sponsors must also provide regular updates involving any protocol changes, trial status changes and adverse events. Results must be reported within a year of the primary completion date of the trial unless an extension is granted by the FDA.

Recently, the FDA has taken steps to improve its oversight of clinical trial data disclosure and enforce regulations more efficiently, such as sending warning letters to sponsors that fail to report results. As of summer 2023, the FDA has sent five <a href="https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/clinicaltrialsgov-notices-noncompliance-and-civil-money-penalty-actions">Notices of Noncompliance</a>.

The pharmaceutical industry, universities, principal investigators and others involved in clinical research should review their clinical trial reporting policies to ensure confirm that compliance is achieved and penalties are limited.

Are You Complying with ClinicalTrials.gov Reporting Obligations?