New Bill Would Change Clinical Trial Registry Reporting Requirements and Enforcement Measures for Studies Supported by Federal Grants

By Kurt R. Karst –      

Representative Tom Reed (R-NY) recently introduced legislation (H.R. 5283) that is intended to clarify that the PHS Act’s clinical trial registry data bank reporting requirements apply to clinical trials regardless of a trial’s outcomes.  The bill would also amend the PHS Act to withhold federal grant funding – including funding from the Department of Defense – for responsible parties that fail to comply with the law’s clinical trial registry and results submission requirements.

Section 113 of the Food and Drug Administration Modernization Act of 1997 amended the PHS Act to add Section 402, which directs the Secretary of Health and Human Services (“DHHS”), acting through the Director of the National Institutes of Health (“NIH”), to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (i.e., ClinicalTrials.gov).  Section 801 of the FDA Amendments Act of 2007 (“FDAAA”) expanded ClinicalTrials.gov to include a broader range of “applicable clinical trials” that must be registered and to require responsible parties to submit certain results information from applicable clinical trials to the clinical trial registry data bank.

Under current law, an “applicable clinical trial” is defined to mean an “applicable device clinical trial” or an “applicable drug clinical trial.”  Each of those terms is further defined in the law at PHS Act § 402(j)(1)(A).  Rep. Reed’s bill would amend the “applicable clinical trial” definition at PHS Act § 402(j)(1)(A)(i) to clarify that a drug or device trial is an applicable clinical trial “whether or not such a clinical trial results in a positive or negative outcome.”  This proposed change appears to be intended to address concerns about the underreporting of clinical trial results on ClinicalTrials.gov.  As we previously reported, according to an article published in the January 2012 issue of the British Medical Journal, a database search of trials registered on ClinicalTrials.gov which completed in 2009 and that are covered by FDAAA showed that “[o]f the 738 trials that were classified as subject to mandatory reporting, 163 (22%) had reported results.  In comparison, 76/727 (10%) trials covered by the FDAAA but not subject to mandatory reporting had reported results . . . . ”  More recently, there have been concerns expressed about pediatric clinical trial reporting issues – see here. 

Rep. Reed’s bill would also amend PHS Act § 402(j)(5)(A), which concerns clinical trials supported by grants from certain federal agencies, both with respect to scope and enforcement.

Under current law (PHS Act § 402(j)(5)(A)(i)), “[i]f an applicable clinical trial is funded in whole or in part by a grant from any agency of the [DHHS], including the [FDA], the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH” under PHS Act § 402(j)(2) and (3) concerning clinical trial reporting requirements.  First, H.R. 5283 would broaden the law to include any agency of the Department of Defense.  That change would also make PHS Act §§ 402(j)(5)(A)(ii)-(iv) applicable to clinical trials supported by Department of Defense grants.  Those sections of the law require, among other things, the heads of the agencies identified under PHS Act § 402(j)(5)(A)(i) to “verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under [PHS Act § 402(j)(2) and (3)] before releasing any remaining funding for a grant or funding for a future grant to such grantee,” and if the agency head “verifies that a grantee has not submitted clinical trial information . . . , such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.”

Second, Rep. Reed’s bill would amend PHS Act § 402(j)(5)(A) to add a new subsection on “enhanced enforcement” that would withhold grant funding for failure to report required clinical trial information on ClinicalTrials.gov.  Specifically, the new section of the law would state:

(v) ENHANCED ENFORCEMENT. – After the 30-day period described in [PHS Act §§ 402(j)(5)(A)(iii)], if the head of an agency referred to in [PHS Act §§ 402(j)(5)(A)(i)], as applicable, verifies that a grantee has not submitted clinical trial information as described in [PHS Act §§ 402(j)(5)(A)(ii)], with respect to an applicable clinical trial that is funded in whole or in part by a grant from the agency, such grantee –

(I) shall not be eligible to receive any remaining funding for the grant or funding for a future Federal grant until such time as the grantee comes into compliance with all applicable reporting requirements under this subsection; and

(II) shall be liable to the United States for repayment of any amount provided under the grant for the clinical trial for which the grantee failed to comply with such reporting requirements.

According to a May 3, 2012 press release from Rep. Reed, although current law requires that results of clinical trials conducted with federal money be publicly reported, “the enforcement mechanism is very weak” and as a result not all research – and in particular cancer research – is being reported.