EQUITABLE ACCESS TO CLINICAL TRIALS & THE CLINICAL TRIAL MODERNIZATION ACT

Access to clinical trials is more than a gateway to groundbreaking research. It’s a critical lifeline for patients seeking innovative treatments that demands the elimination of financial barriers to ensure equitable participation for all. 

The Equitable Access to Clinical Trials (EACT) initiative and the Clinical Trial Modernization Act (CTMA) are game-changers, striving to make trials more inclusive by tackling these economic hurdles. Read on to get up to speed on both critical initiatives.  

Understanding Equitable Access to Clinical Trials (EACT)  

The Equitable Access to Clinical Trials (EACT) initiative is a significant step in making clinical trials more accessible to everyone, no matter their financial situation. Hosted by the LUNGevity Foundation, EACT addresses the financial challenges that often prevent many patients from participating in clinical trials. While these trials are essential for developing new treatments, financial hurdles can limit participation to those who can afford their additional costs – leading to less diverse and less representative data. 

Background and Inception of EACT 

Originally known as the Financial Neutrality Initiative, EACT was created to remove financial barriers for patients, allowing more people to participate in clinical trials. It was rebranded to emphasize its mission of ensuring fair access to clinical trials, aiming to create an even playing field for all patients, regardless of their financial circumstances. The initiative took off in early 2023 when Scout and other key players collaborated with a large pharmaceutical client to tackle these financial issues directly. This partnership sought to establish a structure that would make it economically viable for a broad spectrum of individuals to participate in clinical research. 

Key Objectives of EACT 

EACT has two main goals: identifying and funding participant costs, and developing best practices for financial support. 

1. Identifying and Funding Participant Costs 

EACT's first task was to identify a comprehensive list of costs that should be covered by trial sponsors. These costs include non-medical expenses like travel, lodging, meals, and childcare. By clearly outlining these expenses, the initiative provides a roadmap for sponsors to offer substantial financial support, reducing the economic burden on participants. 

2. Developing Best Practices for Financial Support 

Expansion and Collaboration with Industry Stakeholders 

Since it started, EACT has grown to include about 60 participants from various areas of the healthcare and research sectors. These participants include big pharmaceutical companies, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), academic institutions, and patient advocacy groups. This wide-ranging collaboration enriches the initiative with diverse insights and ensures that the practices and policies developed are applicable across different types of trials. 

The partnerships among these stakeholders have been crucial in creating resources that are now available through the EACT platform. These resources serve as guides for sponsors and trial sites, helping them navigate the financial aspects of supporting participants. The collective effort of these industry leaders highlights a shared dedication to breaking down the financial barriers that have long limited access to clinical trials. 

In essence, the EACT initiative is transforming how clinical trials are conducted, making them accessible to all patients, regardless of their financial situation. By tackling financial challenges head-on and promoting collaboration across the industry, EACT is paving the way for clinical trial participation to be an option for everyone, ultimately improving the quality and diversity of clinical research data. 

Scout’s Role in Driving EACT 

Scout has played a pivotal role in the Equitable Access to Clinical Trials (EACT) initiative, actively contributing to its mission of breaking down financial barriers to clinical trial participation. This involvement has allowed Scout to leverage its expertise and resources to drive meaningful change in the industry. 

Participation in Working Groups 

Scout's commitment to EACT is evident through its active participation in several key working groups. Notably, Scout has been a significant contributor to the Best Practices Working Group and the Tax & Legal Issues Working Group. 

Best Practices Working Group 

In this group, Scout has worked alongside other industry leaders to develop and refine best practice guidelines that can be implemented by clinical trial sponsors. These guidelines are designed to streamline the process of offering financial support to participants, ensuring that trials are more accessible and inclusive. Scout's input has been crucial in shaping policies that are both practical and impactful.

Tax & Legal Issues Working Group 

Scout's participation in the Tax & Legal Issues Working Group has focused on navigating the complex regulatory landscape surrounding financial support for trial participants. By addressing these legal and tax considerations, Scout has helped create frameworks that protect both sponsors and participants, making it easier to offer comprehensive support without legal complications. 

Contribution to EACT Resources and Publications 

Scout's contributions extend beyond working groups to the development of valuable resources and publications. A highlight of this work is Scout's involvement in co-authoring manuscripts and materials on financial neutrality. These publications serve as essential resources for sponsors, providing guidance on how to implement effective financial support mechanisms while maintaining compliance with relevant regulations. 

Scout’s Perspective on EACT's Impact 

Kristin Hermann, Executive Vice President of Strategic Accounts at Scout, has played a highly influential role, representing Scout with her technical prowess. “Scout's involvement in EACT underscores our commitment to eliminating financial barriers to clinical trial participation,” says Hermann. “By developing comprehensive resources and advocating for policy change, we aim to empower sponsors and participants alike.” 

Through these efforts, Scout supports the objectives of the EACT initiative and positions itself as a leader in advocating for equitable access to clinical trials. In focusing on practical solutions and policy advocacy, Scout is helping to pave the way for a more inclusive and diverse clinical research environment. 

The Clinical Trial Modernization Act (CTMA): What You Should Know 

The Clinical Trial Modernization Act (CTMA) represents a transformative shift in how clinical trials are conducted and accessed. This legislative initiative aims to enhance the reach and efficiency of clinical trials, ensuring they are more inclusive and adaptable to the needs of participants. 

The CTMA's journey through the legislative process reflects a growing recognition of the barriers that participants face, particularly those related to financial and logistical challenges. Advocates for the act have worked tirelessly to address these barriers, ensuring the act's provisions align with modern healthcare demands. 

At its core, the CTMA provides comprehensive financial support, covering both medical and non-medical costs incurred by participants. This support extends beyond the basic necessities, offering a safety net that makes trial participation feasible for a broader demographic. Additionally, the act emphasizes the use of technology to facilitate remote participation, removing geographical barriers and making trials more accessible to individuals regardless of their location. 

Another significant aspect of the CTMA is its focus on tax implications and the establishment of safe harbors. These measures aim to streamline the financial processes associated with trial participation, reducing the administrative burden on participants and sponsors alike. By addressing these critical components, the CTMA paves the way for a more modern and inclusive approach to clinical research, ensuring that trials are not only scientifically robust but also participant-friendly. 

Want to learn more about the tax implications of clinical trial participation? Read Scout’s latest eBook, Evolving Compensation Models in Clinical Research.  

 
Connecting the Dots: EACT and CTMA's Shared Vision 

The  Equitable Access to Clinical Trials (EACT) and the Clinical Trial Modernization Act (CTMA) are crucial initiatives aimed at easing the financial burdens of clinical trial participation. Both of these programs strive to make clinical research more inclusive and accessible by addressing cost-related challenges. 

Both EACT and CTMA focus on reducing financial obstacles for participants. The EACT provides immediate financial support to patients needing access to experimental treatments, ensuring that the cost does not become a barrier to urgent medical care. Similarly, the CTMA is designed to cover a broad range of expenses, both medical and non-medical, making it easier for more people to take part in trials. 

These initiatives complement each other well. EACT's focus on quick patient access to necessary treatments aligns with CTMA's legislative efforts to make clinical trials more efficient and modern. By combining EACT's practical patient access strategies with CTMA's legislative support, they create a cohesive experience that benefits trial participants. 

Scout's advocacy efforts have been a driving force behind the progress of the CTMA. Acknowledging the need for modernized clinical trials, Scout has been actively involved in lobbying to ensure the act meets the needs of both patients and researchers. Through strategic efforts and ongoing support, Scout has highlighted the important issues the CTMA addresses, playing a crucial role in shaping the future of clinical trials. 

Together, EACT and CTMA are paving the way for a more participant-friendly and financially accessible clinical trial environment. By working in tandem, these initiatives support scientific progress and, more importantly, prioritize the needs and well-being of participants. 

The Importance of Financial Neutrality in Clinical Trials 

Financial neutrality is crucial for ensuring that all patients can participate in clinical trials, irrespective of their economic status. Financial barriers often prevent people from joining, which can skew data and affect the validity of research findings. 

Financial Hurdles in Patient Participation 

Many individuals face financial challenges like travel expenses, lost wages from taking time off work, or childcare costs. These hurdles can deter participation, especially among those from low-income backgrounds, resulting in data that doesn't fully represent the entire population. 

Why Inclusive Trial Data Matters 

Diverse data is essential for developing treatments that work across different demographics. Without broad representation, trial results may miss how various groups respond to treatments. Financial neutrality allows participants from all socioeconomic backgrounds to be included, creating more reliable data. 

How Financial Constraints Shape Participation 

Imagine a single parent with limited income unable to afford time off work for trial appointments, or an elderly person on a fixed income who can't cover transportation costs. These examples show how financial constraints can exclude participants and impact the diversity of trial data. 

Focusing on financial neutrality in clinical trials enhances the quality of research. Removing financial barriers helps create an environment where diverse participation is standard, leading to better and more applicable medical advancements. 

Scout's Ongoing Commitment and Future Steps 

Scout is set to make significant strides in trial equitability going into 2025. Here's how:

1. Participation in Working Groups

Scout will actively engage in various working groups throughout 2024. By being at the forefront of these discussions, Scout aims to shape strategies that enhance inclusivity and accessibility in clinical trials.

2. Financial Support Practices

Scout is committed to sharing and developing financial support practices that break down economic barriers. This involves disseminating successful strategies that other organizations can adopt to ensure financial constraints do not impede trial participation.

3. Collaborations for Innovation

In collaboration with industry leaders, Scout plans pilot studies that will test innovative approaches to clinical trials. These partnerships are expected to generate valuable insights that can lead to more effective and inclusive trial designs. 

4. Advocacy for Policy Changes

Continuous advocacy remains a cornerstone of Scout's efforts. By pushing for policy changes that emphasize financial neutrality, Scout aims to remove financial obstacles and encourage diverse participation in clinical trials. 

Through these initiatives, Scout is laying the groundwork for a future where clinical trials are accessible to everyone, regardless of financial status. 

Both EACT (Equitable Access to Clinical Trials) and CTMA (Clinical Trial Management Accessibility) are key drivers on the journey toward equitable clinical trials. These initiatives break down the financial and logistical barriers that have traditionally hindered diverse participation in clinical research, thereby enriching the quality and scope of research outcomes. By embracing these frameworks, the industry takes a significant step towards a more inclusive future in medical research. 

Sponsors, CROs and stakeholders can act today to ensure today’s clinical trials take a proactive approach to relieving patient burden and boosting retention for diverse populations. Scout takes a strategic, proactive approach to patient payments, travel, and logistics. We evaluate patient needs and potential scope based on country mix, therapeutic area, and more, ensuring a perfect fit for both sponsor and patients. 

With Scout, you gain access to practical recommendations backed by experience in over 100 countries to fit where you’re working and who’s involved. Contact us today to learn about pre-arranging patient support services to mitigate patient burden before issues arise.