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.
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.Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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