On Friday the National Institutes of Health (NIH) published an extensive proposed rule, intended to clarify and expand the requirements for submission of clinical trial registration and results information to the ClinicalTrials.gov data bank. See 79 Fed. Reg. 69,566 (Nov. 21, 2014). The rulemaking proposes to add a new Part 11 to Title 42 of the CFR to implement the statutory requirements set forth in section 402(j) of the Public Health Service Act (PHSA). Section 402(j) had been added to the statute by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Citing “ongoing public interest in the transparency of information concerning clinical trials”, NIH has proposed—among other things—to extend the requirement for disclosure of results information to encompass applicable clinical trials of drugs, biological products, and devices that are not approved, licensed, or cleared by FDA. This proposal, if finalized, would mark a substantial departure from current requirements. Currently, a responsible party must submit results information only for applicable clinical trials of products that are approved, licensed, or cleared by FDA.
Although the proposed rule would allow up to one year after the completion date of an applicable clinical trial for posting the results on ClinicalTrials.gov, and furthermore would accommodate a delay of up to two additional years from the date of a timely certification that the unapproved product (or a new use of an approved product) is still under development, this proposed rule could nevertheless require that a responsible party post results from an applicable clinical trial before the product (or new use) is approved. Traditionally, sponsors sometimes have regarded such results as confidential prior to a product’s approval by FDA or a decision to discontinue development.
Other notable provisions of this rulemaking include:
- “[A]n extensive elaboration” on the agency’s interpretation of the term “applicable clinical trial”, which determines which clinical trials are subject to registration and reporting requirements under section 402(j);
- Proposed additions to clinical trial registration information that must be submitted to the data bank, including the status of ethical and scientific review;
- Continued submission of adverse event (AE) information for an applicable clinical trial by study arm and organ system, in two tables (one for all serious AEs, and another for AEs that occurred with a frequency of 5% or more in any study arm); and
- Proposed updates of information on at least an annual basis, as well as timely corrections to any errors discovered by the responsible party or the agency.
The proposed effective date of these proposed regulations is 45 days after publication of the final rule in the Federal Register, with a proposed compliance date of 90 days after the effective date. Comments on this proposed rule are due on or before February 19, 2015.
The author wishes to thank Komal Karnik for her efforts.