Open Up Your Eyes: FDA Expects Real Transparency in ClinicalTrials.gov Disclosures

Based on client inquiries and FDA actions, the Food and Drug Administration is focusing more on companies not submitting data to www.ClinicalTrials.gov. It is taking stronger action against those companies it believes are non-compliant.

To paraphrase Tonic’s 1996 hit song, “Open Up Your Eyes,” the agency wants companies to open up about certain types of clinical data when they submit the information on ClinicalTrials.gov. In this Bulletin, we will summarize the relevant law, note where FDA seems to be focusing, and provide our observations.

Background

A sponsor or the principal investigator of a clinical trial (responsible party) must register with and submit clinical trial results information for an “applicable clinical trial” to the ClinicalTrials.gov data bank.¹ Submission of “applicable clinical trial” (defined below) results information promotes transparency.² Clients are asking us about what qualifies as an “applicable clinical trial” and what clinical trial results information must be submitted (typically after an FDA contact).

The law also requires: (1) FDA oversight and enforcement related to failure to submit clinical trial results information to ClinicalTrials.gov;³ (2) companies’ certification of compliance with ClinicalTrials.gov requirements accompanying certain drug, device, or biological product applications; and (3) companies’ inclusion of the following statement in the informed consent documents for an applicable clinical trial:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

Highlights of the Law

• An “applicable clinical trial” is an “applicable device clinical trial” or an “applicable drug clinical trial.” An “applicable drug clinical trial” is a “controlled clinical investigation, other than a phase 1 clinical investigation . . . . ”
• “Controlled” means “with respect to a clinical trial, that data collected on human subjects in the clinical trial will be compared to concurrently collected data or to non-concurrently collected data, as reflected in the pre-specified primary or secondary outcome measures.”
• Responsible parties must generally submit clinical trial results within a year of the completion of the “applicable clinical trial,” unless the responsible party has submitted a timely certification of delay, a request for an extension for good cause, or a request for a waiver of the requirements for submission of results information.
• FDA can send a Pre-Notice Letter if a responsible party fails to submit clinical trial information for an “applicable clinical trial.”
• The Pre-Notice describes the potential violation and requests that the party take necessary actions to comply within 30 days after receiving the letter.
• Thirty days after receipt of a Pre-Notice Letter, FDA reviews the information submitted to determine whether a violation still exists.
• If the agency decides that a responsible party failed to submit required clinical trial information to the ClinicalTrials.gov databank, FDA will issue the responsible party a Notice of Noncompliance.
• FDA will then post the Notice of Noncompliance on its website and send the Notice of Noncompliance to The National Institutes of Health so it can include the Notice in the ClinicalTrials.gov databank.
• A Notice of Noncompliance provides the recipient an opportunity to comply within 30 days; FDA will generally seek civil monetary penalties of thousands of dollars (depending on certain factors) if a responsible party does not fix the issue within 30 days of the notice.
• Other regulatory penalties, such as injunction and/or criminal prosecution, are also possible.
• As of the issuance date of this Bulletin, FDA has issued 18 Preliminary Notice of Noncompliance (Pre-Notice Letters) in 2024; FDA issued 39 Pre-Notice Letters in 2023.
• FDA generally identifies violations through its Bioresearch Monitoring Program and through complaints received.

AGG Observations

• There are reasons why a company might prefer not to disclose publicly certain data and, if there is a legal or regulatory rationale, it might be able to refrain. However, if the company is wrong in its assessment, it will likely incur regulatory scrutiny and potential enforcement.
• As the aforementioned Tonic song continues, “Don’t let your mind tell the story here.” FDA wants the responsible party to provide the data in an open and objective manner. Viewers of ClinicalTrials.gov should be able to open their eyes to factual data, so that they don’t have to have their mind tell the story.

[1] 42 C.F.R. § 11.48.

[2] https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/fdas-role-clinicaltrialsgov-information.

[3] https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82. This Bulletin will focus on FDA oversight and enforcement of submission of clinical trials results information to ClinicalTrials.gov and not the certification and informed consent requirements.