SCRS Stands Up for Low Income, Elderly, Disabled Populations

There is a lot of discussion about diversity in clinical trials. The “why” is clear – more representation is needed to assess the effects of treatment on different people, across race, sex, age and so on, including intersections therein.

Diversity is required to benefit the science and progress our understanding of various drugs and treatments – determining how treatments work for biological males vs females, for example, or whether medicines tested in adults can be safely used for children. And of course, to enable clinical research as a care option for all. It’s the latter that I believe will move the needle to gain more patient participation. It is also a factor that requires a broader diversity lens that includes equity and inclusion.

The crux of the complexity here is the “how” – how to go about increasing diverse representation. One could argue it starts early with study design and factoring in biological differences that could unintentionally result in excluding a diverse patient pool.

Diversity is a Journey, not a Destination

Forums like the recent SCRS Diversity Summit bring together sites, sponsors, CROs, and advocates to have meaningful conversations about moving the industry forward. When it comes to diversity, equity and inclusion (DEI), patient recruitment is an ongoing engagement and not a final destination. Education and awareness are ways to engage with local communities and build trust.

Overcoming distrust doesn’t happen easily – and maybe not even within a generation in some populations. It’s a long-term commitment, which takes money, time, and effort. It’s no surprise, then, that during the SCRS conference sites consistently talked about the need for allocated DEI budgets and marketing support. This is requested on top of the usual trial marketing budget.

DEI initiatives are primarily relationship building activities. There is a worry that without sustained involvement in underserved communities, DEI efforts will be perceived as purely transactional to hit a recruitment target for a given trial. This is where research as a care option must foster a mutually beneficial partnership between patients and clinical studies – one that satisfies the need for research data while at the same time providing high quality care for the participants.

Lobbying for Greater Inclusion

There are recognized systemic challenges facing equity and inclusion. To this point, SCRS champions action. During the conference, the team prepared a letter for people to send to their US congressional representatives to advocate changes that will allow more people to participate in clinical trials. In particular, the letter advocates for changes that support participation opportunities for low-income, elderly and disabled patient populations.

The letter opens with: “Acknowledging health as a human right recognizes a legal obligation to ensure access to timely, acceptable, and affordable health care. Yet we continue to perpetuate health disparities through existing legislation that works for some but not all – especially as it relates to clinical trial access and diversity.”

The letter highlights several actionable items to remove unnecessary friction for patients entering a clinical trial, such as:

1. Making patient reimbursements non-taxable income
2. Eliminating unfair hurdles that burden the enrollment of the Medicaid population
3. Revising travel reimbursement to make it more equitable
4. Allowing clinical trial sponsors to pay for Medicare beneficiaries’ co-pays and deductibles for routine care items and services required by qualifying clinical trials
5. Simplifying the complex and inconsistent rules for the Centers for Medicare & Medicaid Services (CMS)

Legislation to Expand Research and Access to Treatment

The letter requests to have the points above included in the Cures 2.0 Act, which expands on the 21st Century Cures Act from 2016. Building on the previous legislation, the Cures 2.0 Act now aims to fund research to cure challenging diseases like cancer and Alzheimer’s, as well as improve how new treatments are delivered to patients, with approaches such as:

• Increasing diversity in clinical trials with reporting requirements of trial demographics and recruitment campaigns targeted at underserved populations
• Requiring the FDA to improve the collection and use of real-world evidence
• Expanding access to new health care technologies to Medicare beneficiaries
• Making telehealth services more accessible for Medicare, Medicaid and Children’s Health Insurance Program beneficiaries

Send the Letter to Your Congressional Representation

More than 150 people signed the letter during the SCRS Diversity and Oncology Summits in Austin, including myself. If you are interested in submitting a letter to your US congressional representative, please contact Jackie Kent, SCRS Vice President of Strategy and Special Projects.

Kelly Brown

Guest