Comments to NIH on Proposed Rulemaking

Summary:
Three additions to the Notice of Proposed Rulemaking HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003 regarding presentation of clinical trials data on ClinicalTrials.gov are proposed: 1) the trial’s responsible party will state explicitly whether full clinical trial data is available; 2) all documents related to delayed submission of results will be presented; and 3) members of the public will have a right to appeal any delayed submission of clinical trials results to ClinicalTrials.gov.

 

  1. In order to promote data availability by rewarding those study sponsors who have policies to release their full clinical study reports (*), the trial’s responsible party will be required to state explicitly on ClinicalTrials.gov, for example by check box, whether full clinical trial data, including Clinical Study Reports (CSR’s) or patient-level data, is available.
If full clinical study data is available, the location of such data and the contact information for questions about such data will also be presented on ClinicalTrials.gov.
The preceding recommendation is potentially relevant to HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003 Subpart D “Additional Submissions of Clinical Trial Information”, § 11.60. A statement such as proposed above concerning the availability of full clinical trials study data could be added in a new subsection (c).
(*) e.g. GSK, Roche, and others – see http://www.gsk-clinicalstudyregister.com/compounds/a-f/clinicalstudyreport, http://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm, and https://www.clinicalstudydatarequest.com)

 

  1. In order to further promote open access to clinical trial decision-making, it is recommended that a statement such as the following be added to the NPRM:
All documentation related to HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003, Subpart C (Results Submission) § 11.44 (b)-(e) re delayed submission of results with certification or for good cause, and § 11.54 re waiver of the requirement to submit clinical trial results information, will be presented on the ClinicalTrials.gov site within 30 days of receipt, filing, or response to or by any relevant U.S. government agency.

 

  1. It could be beneficial to give the public, e.g. subjects and their representatives, as well as other interested researchers and experts, a right to appeal any reasons given to delay the presentation of clinical trial results, or to request full trial data.
The following additional statement is suggested for the HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003 at a subsection dealing with rights of clinical trials subjects and other members of the public:
Subjects, their representatives, or other members of the public, will have [some specified amount of time, e.g. 180 days]
to file an appeal to the Director after the posting of, or notification of,
any sponsor certification for delay or request for extension (as per § 11.44 (b)-(e)), or waiver to file clinical trial results (as per § 11.54). Reasons for requesting full trials data could be submitted at any time.
Excerpt of any public request or appeal, and contact information for parties who have filed such a request or appeal, will be made available in a database as a link on ClinicalTrials.gov. Such a database could foster communication among interested parties.

 

Robert P. Bauchwitz M.D., Ph.D.,
Amerandus Research
BNY Mellon Center
1735 Market Street, Suite 3750
Philadelphia, PA 19103
March 2015
Posted in Uncategorized.

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