DIVERSE Trials Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Aug 13, 2021)
Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act or the DIVERSE Trials Act
This bill requires activities to increase diversity in clinical trials. It also expands reporting by laboratories that test for and diagnose COVID-19 and requires a study on data collection and data sharing during public health emergencies.
Specifically, the Food and Drug Administration (FDA) must issue guidance on decentralized clinical trials to promote meaningful demographic and geographic diversity in patient engagement, enrollment, and participation. Decentralized clinical trials include those executed through telemedicine or other digital technologies to allow for the remote collection and assessment of clinical trial data. The FDA may also work with foreign regulators to harmonize international regulations governing decentralized clinical trials and the use of digital health technology.
In addition, the Department of Health and Human Services (HHS) may support community education, outreach, and recruitment activities for clinical trials of treatments for conditions that disproportionately impact populations underrepresented in clinical trials.
The bill also specifies that drug or device manufacturers may provide, subject to some limits, free digital health technologies and other remuneration to patients in approved clinical trials without violating laws that address fraud and abuse in federal programs.
Furthermore, laboratories that test for and diagnose COVID-19 must report additional demographic data, including information about social determinants of health. HHS must also contract with the National Academy of Medicine to study and propose a design for an interoperable platform to facilitate data sharing during public health emergencies.
What just happenedAug 16, 2021
Referred to the Subcommittee on Health.
Who’s behind it
- Introduced in HouseAug 13, 2021
- Aug 16, 2021Committee
Referred to the Subcommittee on Health.
Health Subcommittee - Aug 13, 2021Committee
Referred to the Subcommittee on Health.
Health Subcommittee - Aug 13, 2021IntroReferralH11100
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Ways and Means Committee - Aug 13, 2021IntroReferralH11100
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Energy and Commerce Committee - Aug 13, 2021IntroReferralIntro-H
Introduced in House
- Aug 13, 2021IntroReferral1000
Introduced in House