January 25, 2021

Volume XI, Number 25


January 22, 2021

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New Clinical Trial Rule Alters Reporting Requirements

New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health and Human Services (HHS) issued a Final Rule creating new requirements for posting of clinical trials results information, which can be viewed at ClinicalTrials.gov

The Final Rule intends to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials.

Sponsors and sponsor-investigators of clinical trials should be aware of the following:

  • Interventional clinical trials with one or more arms and one or more pre-specified outcome measures must be registered on ClinicalTrials.gov and their results information must be posted following completion of the trial.

  • The sponsor of a clinical trial can delegate its duty to register and post results to a qualified Principal Investigator, who then becomes the "Responsible Party."

  • Although an expanded access trial is not an "Applicable Trial" requiring registration, the Responsible Party must still submit information about whether an unapproved drug or biologic product is available for expanded access so that information can be linked in the database.

  • Results information must now be posted for drug, biologic, and device products that are not yet approved, as well as those that are approved by the Federal Food & Drug Administration (FDA), though there is the option to delay posting under certain circumstances.

  • Adverse event information that is collected as part of the clinical trial protocol must now be posted as part of the results information.

  • The Responsible Party is required to update the information posted at least annually.

  • The Final Rule sets forth the legal consequences for failing to comply, which include civil and criminal penalties and fines, and the NIH policy states that grant funding can be withheld and non-compliance may be considered in future funding decisions.

© Polsinelli PC, Polsinelli LLP in CaliforniaNational Law Review, Volume VI, Number 300



About this Author

Ana Christian, Polsinelli Law Firm, Health Care Attorney

Ana Christian is spurred by a passion for helping clients bring cutting-edge medical advancements to the patients who need them. An efficient negotiator, her previous experience working with pharmaceutical and medical device companies gives her unique perspective when representing health systems, hospitals, and physicians. Ana advises clients on the Health Insurance Portability and Accountability Act, informed consent, and conflict of interest. She also works with clients regarding Anti-Kickback Statute and Stark Law compliance in research, offering specific insight...