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, plans for achieving the recruitment and retention goals and implementing less-burdensome clinical trial follow-up requirements, and education and training requirements related to diversity in clinical trials for researchers and other individuals who conduct or support the trial. A sponsor must also annually share demographic data of clinical trial participants with the NIH. The NIH must publish on its website information about the diversity of and other information concerning the clinical trials it funds. If a sponsor fails to meet its goals or other requirements with respect to trial diversity, the sponsor must develop and implement a strategic plan to increase the diversity of the clinical trial participants. 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. The bill also requires studies on barriers to participation in clinical trials. The Government Accountability Office must study actions taken by federal agencies to address such barriers while the NIH must study regulations that govern reimbursements of out-of-pocket expenses of and incentives for clinical trial participants.
Sponsors: Rep. Kelly, Robin L. [D-IL-2]
Target Audience
Population: People participating in or affected by clinical trials globally
Estimated Size: 2000000
- The bill targets increasing diversity in clinical trials, which implies a focus on underrepresented groups in medical research.
- This could include racial and ethnic minorities, women, and economically disadvantaged individuals who historically have lower participation rates in clinical trials.
- The NIH funds numerous clinical trials worldwide, meaning this legislation has potential global implications.
- Clinical trials are a critical part of developing new medications and treatments, impacting patients with conditions under study.
- Researchers and healthcare professionals involved in designing and implementing clinical trials will also be impacted by the new requirements.
Reasoning
- The NIH Clinical Trial Diversity Act aims to address disparities in clinical trial representation which could lead to more inclusive health data and better outcomes for underrepresented groups.
- The policy could increase access to clinical trials for minority groups, potentially improving health equity.
- Implementation could also impose financial and administrative burdens on trial sponsors, affecting smaller organizations more.
- The policy's requirement for transparency and diversity targets could lead to improved public trust in clinical research.
- Given the budget limitation, the policy impacts will likely be focused in areas with existing NIH research infrastructure.
Simulated Interviews
Clinical Trial Coordinator (Chicago, IL)
Age: 35 | Gender: female
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 5/20
Statement of Opinion:
- This policy will help us get more diverse patient pools, which can improve the reliability of our research.
- The overhead of accomplishing these targets might be significant, but the long-term benefits seem worth it.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 9 | 7 |
| Year 10 | 9 | 7 |
| Year 20 | 8 | 6 |
Oncologist (Los Angeles, CA)
Age: 54 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 3/20
Statement of Opinion:
- Greater diversity is a wonderful goal, though I fear the initial costs and efforts could deter some research entities.
- We need to be prepared to offer more support to lessen the administrative load.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 7 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 8 | 6 |
| Year 20 | 8 | 5 |
Public Health Researcher (Miami, FL)
Age: 28 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 4/20
Statement of Opinion:
- This initiative could really help improve minority health outcomes by addressing systemic exclusion from trials.
- Ensuring compliance might be challenging, especially for smaller trials without large budgets.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Patient Advocate (New York, NY)
Age: 45 | Gender: female
Wellbeing Before Policy: 5
Duration of Impact: 15.0 years
Commonness: 6/20
Statement of Opinion:
- Diverse clinical trials can change lives and open up access to better treatments.
- We need to make sure communities are informed and understand the benefits of trial participation.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 6 | 5 |
| Year 3 | 7 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Biotech CEO (San Francisco, CA)
Age: 62 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 5.0 years
Commonness: 2/20
Statement of Opinion:
- The added costs are a hurdle for us, but without diversity, our products might not serve all who need them.
- Government support or incentives could help us bridge this gap effectively.
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 | 8 | 6 |
Clinical Trial Participant (Atlanta, GA)
Age: 29 | Gender: female
Wellbeing Before Policy: 6
Duration of Impact: 20.0 years
Commonness: 7/20
Statement of Opinion:
- I think this creates a better chance for people like me to find trials that work well for us.
- It's reassuring to see the government taking steps to include people of color.
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 | 9 | 6 |
| Year 20 | 9 | 6 |
Regulatory Affairs Specialist (Phoenix, AZ)
Age: 50 | Gender: male
Wellbeing Before Policy: 7
Duration of Impact: 10.0 years
Commonness: 4/20
Statement of Opinion:
- These diversity requirements mean we'll have to rethink our trial designs and resource allocations.
- It's a positive change, but effective implementation will be pivotal.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 7 |
| Year 2 | 8 | 7 |
| Year 3 | 8 | 7 |
| Year 5 | 8 | 7 |
| Year 10 | 8 | 7 |
| Year 20 | 8 | 7 |
Healthcare Policy Analyst (Dallas, TX)
Age: 38 | Gender: male
Wellbeing Before Policy: 6
Duration of Impact: 10.0 years
Commonness: 2/20
Statement of Opinion:
- The expected increased costs need funding to be addressed or they may limit the potential benefits.
- Policy is likely to create better data for health policymaking in the future.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 7 | 6 |
| Year 2 | 7 | 6 |
| Year 3 | 8 | 6 |
| Year 5 | 8 | 6 |
| Year 10 | 9 | 6 |
| Year 20 | 9 | 5 |
Genetics Researcher (Boston, MA)
Age: 41 | Gender: female
Wellbeing Before Policy: 8
Duration of Impact: 15.0 years
Commonness: 3/20
Statement of Opinion:
- Integrating more diverse genetic data can significantly enhance the applicability of our research.
- There are challenges, but the move is ethically and scientifically necessary.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 8 | 8 |
| Year 2 | 9 | 8 |
| Year 3 | 9 | 8 |
| Year 5 | 9 | 8 |
| Year 10 | 9 | 8 |
| Year 20 | 9 | 7 |
Retired Veteran (Houston, TX)
Age: 65 | Gender: male
Wellbeing Before Policy: 5
Duration of Impact: 20.0 years
Commonness: 5/20
Statement of Opinion:
- Representation in trials is essential, and this policy might mean new solutions for many veterans.
- Government-backed initiatives like these can drive necessary change.
Wellbeing Over Time (With vs Without Policy)
| Year | With Policy | Without Policy |
|---|---|---|
| Year 1 | 6 | 5 |
| Year 2 | 7 | 5 |
| Year 3 | 8 | 5 |
| Year 5 | 8 | 5 |
| Year 10 | 9 | 5 |
| Year 20 | 9 | 5 |
Cost Estimates
Year 1: $5000000 (Low: $4000000, High: $6000000)
Year 2: $5000000 (Low: $4000000, High: $6000000)
Year 3: $5000000 (Low: $4000000, High: $6000000)
Year 5: $5000000 (Low: $4000000, High: $6000000)
Year 10: $5000000 (Low: $4000000, High: $6000000)
Year 100: $0 (Low: $0, High: $0)
Key Considerations
- Ensuring compliance with diversity goals without hindering the overall progress of clinical research.
- Balancing investments in awareness campaigns to effectively reach target populations without excessive spending.
- Monitoring the impact of diversity initiatives on trial efficiency and participant outcomes.
- Incorporating feedback from diverse communities to continue improving trial inclusivity strategies.