Achieving diversity in clinical trials is crucial for developing effective and safe treatments for all populations. Yet, financial barriers often exclude underrepresented groups from participating, hindering progress towards health equity. This disparity raises critical questions about the accessibility and inclusivity of medical research.
In this insightful Q&A, Meghan Harrington, VP of Clinical Trial Financial Management at Medidata, a Dassault Systèmes brand, sheds light on the financial challenges hindering diversity in clinical trials. She explores how financial constraints, such as limited banking access and tax implications, disproportionately affect underrepresented patients. Furthermore, she delves into the cash flow issues plaguing trial sites and discusses how innovative platforms are addressing these challenges to promote greater inclusivity in medical research.
What policy changes or regulatory adjustments are needed to address the financial barriers faced by patients and trial sites?
Meghan Harrington, VP of Clinical Trial Financial Management at Medidata: There is a growing body of literature on the financial toxicity of healthcare that details the patient financial burdens related to the cost of medical care. This research has recently turned to the clinical trial experience. In a 2023 NIH study, the authors cite that the burdens are similar to those in standard of care settings and also include unique stressors due to travel burden and increases in indirect costs. As an industry, we can take meaningful steps to reduce the financial challenges and distress surrounding the cost of clinical trial participation. First, we can increase the practice of compensating patients for their time and effort in clinical trial research. Second, we must advocate for comprehensive policies that simplify financial interactions and ensure regulations improve patient accessibility and inclusivity. Two important pieces of congressional legislation proposed earlier this year seek to do just that: The Clinical Trials Modernization Act (HR 8412) and The Harley Jacobson Act (HR 7418). These bipartisan bills seek to remove the tax liability of clinical trial remuneration as well as ensure the payments will not negatively impact the individual’s income qualifications for programs such as Medicare or Social Security. The Modernization Act was published in partnership with the American Cancer Society Cancer Action Network and initially focused on individuals with cancer and life-threatening diseases earning up to $2000. The Harley Jacobson Act builds on this by extending the reach to all patients and caregivers and removes the tax liability for all payments regardless of amount. As the industry seeks ways to address the financial barriers faced by patients and trial sites, it is important that we push for robust legislative action that guarantees a better, more equitable patient experience across the board.
Why are equitable patient payments essential for achieving diversity in clinical trials?
Meghan Harrington: Equitable patient payments are essential for achieving diversity in clinical trials because they determine who can realistically participate. A meaningful portion of the population is unbanked or uncomfortable sharing banking information, leading to their exclusion from trials because of rigid payment methods. This disproportionately affects lower-income communities, leaving them underrepresented in drug development. Additionally, the tax implications tied to payments can deter participation. Offering flexible and varied payment options can bridge this gap, ensuring that clinical trials are truly inclusive and reflective of diverse populations. Without equitable payments, we risk perpetuating a cycle of inequity in medical research.
How are innovative platforms addressing the cash flow challenges faced by trial sites?
Meghan Harrington: Innovative platforms like the Medidata Patient Payments platform are transforming how trial sites manage cash flow by enabling direct payments to patients, funded directly by the Sponsor, alleviating financial pressure on sites to front payments. By bypassing the need for sites to pre-fund payments, these platforms ensure consistent, timely disbursements, enhancing both visibility and compliance while also alleviating the financial reconciliation activities at the end of the study. This predictability allows trial sites to better manage their finances, ensuring they can focus on the critical work of conducting clinical trials without the burden of cash flow challenges.
How do these platforms contribute to improving patient diversity and inclusion in clinical trials?
Meghan Harrington: Platforms like Medidata Patient Payments are crucial for improving patient diversity and inclusion in clinical trials by removing financial barriers that often exclude underrepresented groups. By offering flexible disbursement options and clear education on tax implications, these platforms address the unique financial concerns of participants, including those from lower-income backgrounds. This transparency and flexibility encourage broader participation, ensuring that clinical trial populations are more representative and that outcomes are more inclusive and accurate.
What are the primary reasons behind the 30% cash flow issue faced by trial sites?
Meghan Harrington: One study found that up to 40% of sites withdraw from studies due to cash flow issues, which can include holdbacks on site visit payments, issuing checks to patients and then waiting on reimbursement from the Sponsor, and net 30 or 90 payment terms, all of which place a financial strain on sites. Additionally, the administrative burden of managing tax implications like 1099 forms diverts focus from core operations, further hindering efficiency and the ability to sustain ongoing trials. These challenges make it difficult for sites to maintain financial stability, ultimately impacting the success of clinical trials.
Can you elaborate on the specific financial challenges faced by underrepresented populations that prevent them from participating in trials?
Meghan Harrington: Underrepresented populations face significant financial challenges that hinder their participation in clinical trials, including limited access to banking facilities and the risk of tax implications affecting eligibility for government benefits like Medicare. These barriers often deter participation, but by educating participants and offering versatile payment solutions, we can reduce these obstacles and make trials more accessible to diverse groups.
Any final thoughts?
Meghan Harrington: To overcome financial barriers in clinical trials,we must advocate for comprehensive policies, equitable payments, and innovative platforms like Medidata Patient Payments. These tools ensure diverse, inclusive participation by offering flexible disbursement options and simplifying financial interactions for both patients and sites. Addressing cash flow issues and removing tax-related obstacles are crucial steps toward a more representative and efficient clinical trial process. The ultimate goal is to create a research environment where financial constraints no longer limit who can contribute to and benefit from medical advancements.
About Meghan Harrington
Meghan Harrington serves as the vice president, Product Clinical Trial Financial Management, at Medidata, driving product roadmap and strategy across the Budgeting and Payments solution suite.
Meghan started her career as a Masters level psychologist working within a medical care team treating patients with ALS and traumatic brain injury. It was through this privileged relationship with patients facing devastating diagnoses that Meghan witnessed firsthand the life-saving and life-enhancing effects of medical and therapeutic intervention, thus piquing her interest in the drug development process. Meghan joined a CNS-focused start-up in RTP and has spent the last 15+ years working in the life science technology industry. The last decade of this time has been solely focused on the investigator grant administration domain driving strategy and leading teams implementing payment technology in both BPO and enablement models.