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    Results:

    Subject Term: Trials

    1 publication with a total of 2 open recommendations
    Director: Linda Kohn
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of the Department of Health and Human Services (HHS) should direct the NIH OD to finalize data on clinical trial activity that the OD needs to collect from ICs.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight.
    Recommendation: To enhance its stewardship of clinical trials across the ICs, the Secretary of HHS should direct the NIH OD to establish and implement a process for using those data.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: HHS concurred with this recommendation and stated that the agency plans to complete its efforts to identify additional data that will be collected from the ICs on a regular basis. HHS indicated that these data will provide the OD with readily available information on the number, type, and progress of clinical trials funded across the ICs. HHS stated that a working group of NIH staff with expertise in clinical trials has been assembled to begin developing specific requirements for the enterprise-wide system for clinical trial management and oversight, and that the system will be used by NIH OD and the NIH ICs to meet stewardship responsibilities and for strategic planning and priority setting.