To direct the Secretary of Health and Human Services to carry out a pilot project under which no more than 3 sponsors agree to evaluate the psychological and social distress experienced by patients participating in a clinical trial, conducted by the respective sponsor, of a drug or biological product that is intended to treat a serious or life-threatening disease or condition, and for other purposes.
United States115th CongressHR-2244House of Representatives
Updated: May 5, 2017
Summary
Patient Experience in Research Act of 2017 This bill requires the Food and Drug Administration to carry out a pilot project under which sponsors of new drugs or biological products agree to evaluate: (1) the distress experienced by patients in clinical trials for medications intended to treat a serious condition, and (2) the effects of providing support to distressed patients on the outcome of a clinical trial. The user fee is waived for new drug applications that include data from such an evaluation.
Bill texts
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Timeline
Referred to the House Committee on Energy and Commerce.
House of Representatives
Introduced in House
Referred to the Subcommittee on Health.
House of Representatives
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