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Institutional Review Board

Human Research Protections (HRP)

 

Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs)

(NOT-OD-20-147)


Version August 18, 2020

 

Update:

A Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical trial” (“ACT”)[1] if it was:

  • Initiated after September 27, 2007, or
  • Was ongoing as of December 26, 2007, and if
  • The ACT studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.

When results information is not submitted in a timely manner, NIH may take enforcement action against recipients as outlined in the NIH Grants Policy Statement Section 8.5 and section 402(j)(5)(A) of the Public Health Service Act.

Background:

Section 801 of the FDAAA requires that “Responsible Parties” – clinical trial sponsors or sponsor-investigators – report “Basic Results” for “Applicable Clinical Trials” (ACTs) on ClinicalTrials.gov.

On September 21, 2016, the Department of Health and Human Services (HHS) finalized 42 CFR Part 11, which mostly replicates the FDAAA’s results reporting requirements – with an exception. HHS exempted any ACT completed before January 18, 2017 (the Final Rule effective date), as long as the FDA had not, prior to study completion, granted approval or clearance of the investigational product.

Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020) rejected HHS’ interpretation, ruling that the FDAAA requires Responsible Parties to report Basic Results for ACTs even if FDA grants marketing authorization after the trial is completed.

For More Information:

·Bass, Berry & Sims: Significant Change to ClinicalTrials.gov Reporting Requirements: Ten Years’ Worth of Back Data Owed, written by Clint D. Hermes

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[1]
As defined in section 402(j)(1)(A) of the Public Health Service (“PHS”) Act.

 



[1] As defined in section 402(j)(1)(A) of the Public Health Service (“PHS”) Act.