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From Health Law Daily, November 21, 2014

HHS proposes new requirements for submissions to

By Bryant Storm, JD

HHS and the National Institutes of Health (NIH) have published a notice of proposed rulemaking to make available a Proposed rule clarifying and expanding the requirements for the submission of clinical trial registration and results information to the database. The Proposed rule specifies which clinical trials of FDA regulated products are trials that require information to be submitted to If finalized, the Proposed rule would implement an expanded registry and results data bank to enhance patient enrollment in trials, allow tracking of subsequent progress of clinical trials, provide more complete results, and enhance patient access to clinical trial results. The requirements of the Proposed rule would affect responsible parties for certain clinical trials of drugs, biological products, and medical devices, including pediatric postmarket surveillances of devices (Proposed rule, 79 FR 69566, November 21, 2014). HHS is proposing to exercise its authority to regulate the website under the provisions of section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)). Currently, under section 402(j), sponsors of clinical trials are required to submit registration information, summary results Information for approved products, and adverse events information. HHS, acting through the NIH, is using the authority afforded to it under section 402(j) to expand the summary results information submission requirements. To implement the statutory requirements of the Proposed rule, HHS proposes to add a new Part 11 to Title 42 of the Code of Federal Regulations (C.F.R.). The majority of the substantive provisions of the proposal relate either to registration under section 402(j)(2) of the PHS or results submission under section 402(j)(3)(C) of the PHS Act.

Applicable trials. The Proposed rule sets out which kinds of clinical trials will mandate data submission to the website. Those trials, which would require reporting under the Proposed rule will be known as “applicable trials.” The determination for whether a particular product’s clinical trial information needs to be reported will be made based upon descriptive information submitted at the time of registration.

Responsible party. The reporting requirements rest heavily on the concept of a “responsible party.” The single entity designated as a responsible party is given its label so that only an individual entity will submit information to Generally, the sponsor of a clinical trial is the responsible party, however, if a sponsor designates a qualified principal investigator, the investigator would, in some cases, become the party responsible for submission.

Registration. The Proposed rule would also establish registration requirements, requiring applicable clinical trials to be registered with within 21 days of the enrollment of the clinical trial’s first participant. Certain data elements would be required under the Proposed rule as part of the registration process. The registration requirements would mandate that a responsible party submit descriptive information, recruitment information, location and contact information, and administrative data elements listed in section 402(j) of the PHS Act. The specific data elements required are designed to improve the clinical trial information available to the public and reduce ambiguities in the information.

Expanded access. Under the Proposed rule, would also contain additional information about how patients can obtain expanded access to investigational drugs used in applicable clinical trials. When a drug that is part of a clinical trial is available under an expanded access or compassionate use program, the Proposed rule would require that responsible parties submit an additional expanded access record containing information designed to aid patients in accessing the investigational drug. However, when there are multiple clinical trials for the same drug, a responsible party will be provided the opportunity to link to a past expanded access record for that same drug, so that duplicate records are not formed.

Submission. Regarding results submission, the Proposed rule stands to alter the data submitted to to include not only drugs, biological products, and medical devices that are approved by the FDA but also those that are not approved. If the rule is finalized, the required data would include tables of information “summarizing demographics and baseline characteristics of the enrolled participants and primary and secondary outcomes, including results of any scientifically appropriate statistical tests.” Data would be required to be submitted to not later than one year after the completion of the clinical trial. If the product is still under development, responsible parties may receive up to a two year extension of the data submission deadline and further extensions maybe requested for “good cause” under the proposed requirements.  

Adverse events. The Proposed rule plans to increase required data submissions related to adverse events experienced by participants enrolled in clinical trials. Data submissions would be required to summarize the number and frequency of adverse events and to classify those events by trial, arm and organ system. The submission requirements would mandate two tables of information. The first table would require data on all serious adverse events. The second table would pertain to adverse events “that occurred with a frequency of 5 percent or more in any arm of the clinical trial, regardless of whether such adverse events were anticipated or unanticipated.”

Updates and corrections. Under the HHS and NIH proposal, responsible parties would be obligated to, at least, annually update information related to clinical trials. However, more rapid updating may be required under the Proposed rule in the event that the updates are necessary to ensure the accuracy and functionality of the data for users. Similarly, the Proposed rule intends to require data correction to resolve errors discovered by either HHS or the responsible party during data reviews.

Costs and benefits. HHS believes that industry costs will be minimal and will result primarily from the time needed by responsible parties to collect and submit data to HHS and NIH believe that the increased public access to information will greatly outweigh the minor cost to industry.

Comments. HHS is accepting comments on the Proposed rule through February 15, 2015. The HHS and NIH are looking for comments on the agencies’ proposed implementation of the new rules and additional information that might assist in the implementation.

MainStory: TopStory ClinicalNews DrugBiologicNews MDeviceNews PrescriptionDrugNews SafetyNews FDCActNews

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