Bill Overview
Title: NIH Clinical Trial Diversity Act of 2022
Description: This bill sets out requirements to increase the diversity of clinical trial participants. The bill also requires other activities to foster participation in clinical trials. As a condition of funding from the National Institutes of Health (NIH) for a clinical trial investigating a drug or device, a sponsor's application must include certain information related to diversity in its trial, such as goals for recruiting and retaining trial participants and plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements. A sponsor must also annually share demographic data of clinical trial participants with the NIH. Further, the NIH and the Food and Drug Administration must carry out a national campaign to increase awareness about the need for diverse clinical trials.
Sponsors: Sen. Menendez, Robert [D-NJ]
Target Audience
Population: Global Clinical Trial Participants
Estimated Size: 30000000
- The bill aims to increase diversity in clinical trial participation, thereby widening the scope of trial participants and potentially reaching demographic groups previously underrepresented.
- Efforts to increase diversity would primarily focus on minority groups, older adults, women, and other underrepresented populations.
- Clinical trials often provide access to cutting-edge treatments that are not yet widely available, so improved diversity can enhance the specific health outcomes of these groups.
- The NIH and FDA are involved, suggesting a large-scale implementation across the United States, affecting many U.S. citizens involved in or potentially accessing clinical trials.
- The overall implication is improved health equity, which could affect global populations as methodologies for increased diversity could be adopted internationally, influencing global clinical trial processes.
Reasoning
- The NIH Clinical Trial Diversity Act of 2022 aims to increase diversity among clinical trial participants. This could positively impact minority groups who have traditionally had less access to cutting-edge medical treatments and innovations.
- By widening the scope of participants, clinical trials could yield more comprehensive and applicable results across different demographic groups, enhancing the health outcomes and treatment plans from these trials.
- The policy focuses largely on minority groups, women, seniors, and other underrepresented populations, which could significantly affect their wellbeing through access to innovative treatments.
- The campaign's awareness efforts could also lead to a broader understanding and trust in clinical trials, potentially increasing participation rates across diverse demographic groups.
- The scale of the policy, given its budget and focus through agencies like NIH and FDA, suggests wide-reaching implications across the U.S.
Simulated Interviews
Registered Nurse (New York, NY)
Age: 34 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 5.0 years
Commonness: 8/20
Statement of Opinion:
- I think this policy is needed. In my work, I've seen a lack of diversity in trials firsthand.
- Access to clinical trials means access to new therapies before anyone else, which could be life-saving.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Clinical Research Coordinator (Houston, TX)
Age: 45 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 5/20
Statement of Opinion:
- This initiative could revolutionize how effective treatments are accessed by minority groups.
- It's good that this policy sets concrete diversity goals.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 7 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 7 | 6 |
Tech Entrepreneur (San Francisco, CA)
Age: 29 | Gender: other
Wellbeing Before Policy: 6
Duration of Impact: 3.0 years
Commonness: 9/20
Statement of Opinion:
- More diverse trials could lead to more inclusive health tech solutions.
- Encouraging diversity in trials aligns well with ethical innovation in healthcare.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 6 | 5 |
| Year 5 | 6 | 5 |
| Year 10 | 5 | 5 |
| Year 20 | 5 | 4 |
Retired (Miami, FL)
Age: 52 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 6/20
Statement of Opinion:
- This policy might allow people like me more opportunities to participate in trials that could improve my health.
- I hope the national campaign makes a real difference.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 4 |
Pharmaceutical Sales Representative (Chicago, IL)
Age: 39 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 7/20
Statement of Opinion:
- Connecting diverse participants to clinical trials can lead to better drug safety data.
- This policy will help tailor treatments to fit our diverse populations.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 7 | 4 |
| Year 20 | 6 | 4 |
Retired Teacher (Seattle, WA)
Age: 65 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- I hope this policy means more seniors are included in studies about diseases that primarily affect us.
- Awareness efforts should target our community as well.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 7 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 7 | 6 |
| Year 10 | 7 | 6 |
| Year 20 | 6 | 5 |
Health Insurance Consultant (Detroit, MI)
Age: 41 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 6/20
Statement of Opinion:
- Including more diversity in trials could reduce racial health disparities.
- I fully support the transparency in sharing demographic data with the NIH.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 8 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 9 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
University Student (Boston, MA)
Age: 26 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 0.0 years
Commonness: 9/20
Statement of Opinion:
- As someone studying public health, I see the importance of diverse clinical trial data.
- Policies like this can bring long-term benefits largely unseen.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 6 | 6 |
| Year 3 | 6 | 6 |
| Year 5 | 6 | 6 |
| Year 10 | 6 | 6 |
| Year 20 | 6 | 6 |
Volunteer (Phoenix, AZ)
Age: 70 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- The lack of Native American participation in trials is a real problem that this policy addresses.
- I'm optimistic but cautious about the implementation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 8 | 5 |
| Year 20 | 7 | 5 |
Biotechnologist (Los Angeles, CA)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 4/20
Statement of Opinion:
- Increased diversity can improve the quality and applicability of gene therapies we're developing.
- Meeting these diversity goals is challenging but necessary.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 8 | 6 |
| Year 20 | 7 | 5 |
Cost Estimates
Year 1: $15000000 (Low: $10000000, High: $20000000)
Year 2: $15000000 (Low: $10000000, High: $20000000)
Year 3: $15000000 (Low: $10000000, High: $20000000)
Year 5: $15000000 (Low: $10000000, High: $20000000)
Year 10: $15000000 (Low: $10000000, High: $20000000)
Year 100: $15000000 (Low: $10000000, High: $20000000)
Key Considerations
- The administrative burden on clinical trial sponsors to comply with diversity requirements could lead to increased funding requests.
- Potential long-term savings from a more diverse participant pool contributing to improved drug safety and efficacy profile.