Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

By Donna Libretti Cooke, JD, chief impact officer and owner, ImpactSphere Clinical, LLC; Erin Miller, senior director, Angel Center of Excellence, Tigerlily Foundation; and Jeanne M. Regnante, founder and CEO, Patient 3i

Clinical trial budgets are often locked six months or more before a study begins enrolling participants. This fixed approach fundamentally misaligns with the dynamic, unpredictable nature of participant needs throughout a clinical trial. Participants face life disruptions throughout a study, yet support systems remain largely static. While nonprofit organizations can provide adaptive wrap-around services, clinical operations infrastructure has not evolved to integrate them effectively. What is needed is not just incremental improvement in participant compensation or reimbursement but a fundamental shift that matches the complexity of participants’ lives.

We propose a sponsor-embedded operating framework that addresses the full spectrum of participant burden throughout a clinical trial —  financial, logistical, social, and ethical. Rather than relying on static reimbursement structures set months before enrollment begins, the framework reframes participant support as iterative, ethically grounded, and regulator-aligned — enabling adaptive mechanisms that respond to real-world participant needs as they arise.

These already exist across sponsors, service providers, and nonprofit patient organizations, but the challenge is their integration. The operational disconnect sits at the heart of why the industry’s earnest efforts to improve participant access continue to fall short.

The Unaddressed Problem

Participant needs are dynamic across a trial period, but compensation frameworks are static and full participant support is lacking. Static budgets developed six months or more before enrollment begins cannot respond to the evolving realities participants face throughout a trial.

You don't need clinical trial experience to understand how life's disruptions impact individuals and families. Even the flu can derail schedules, strain resources, and shift priorities. Emotional challenges, caregiving demands, and work disruptions drive down motivation and increase dropout risk.

Patient advocates regularly share devastating stories: a spouse's job loss, sudden loss of health insurance, financial constraints that either devastate a participant financially or force them to withdraw entirely. These are not edge cases; they are the lived reality of trial participation. The gist is simple: If a patient needs $500 to get to a clinical trial treatment and they only receive $200, they still can’t get there. And travel reimbursement is only one small piece of the necessary support structure.

Beyond Financial Reimbursement

Financial reimbursements and time-and-effort payments are still lagging (or close to non-existent) and do not sustain participation. Three proof points illuminate this landscape: WCG’s five-year review of IRB consent data on compensation categories paid¹, ASPE 2025 Issue Brief analyzing public data from clinicaltrials.gov² and WCG’s 2026 Trends & Insights Report.³  Both the WCG IRB data review and ASPE Issue Brief confirm that while certain payment categories are covered, amounts are woefully low and lacking in some therapeutic areas and/or trial phases.

Meanwhile, time-and-effort payments remain a point of consternation (allowed in the U.S. and several countries). Surprisingly, WCG’s most recent data review uncovered wide disparities in time and effort payments. The study “revealed that 95% of studies do not offer compensation beyond basic reimbursement.”⁴ The study then pulled out a striking discovery when examining multi-site trials: “standard deviations in participant compensation ranged from $9 to $170.”⁵ These much-needed landscape analyses illuminate how much ground the industry still has to cover.

Why Nonprofits Struggle To Support Clinical Trials 

Several industry service providers now offer valuable participant compensation and concierge services and should be recognized for expanding help over the past few years. Yet efforts to integrate nonprofit organizations that provide comprehensive patient wrap-around services into clinical operations have struggled to gain traction within large pharma. The challenge is rarely willingness. Rather, current contracting, compliance, and operational frameworks were not designed with small nonprofit service organizations in mind.

As Erin Miller experienced during her time with The Lazarex Cancer Foundation, the operational pathways within clinical operations were often difficult to navigate. Lazarex spent years and significant resources attempting to find a pathway to provide patient wrap around services directly with sponsors. Despite clear alignment on the value these services could provide, sponsors frequently struggled to fit nonprofit support models into existing vendor contracting structures. Grants and sponsorships were simply not a sustainable solution. This is part of the reason why in December 2025 Lazarex Cancer Foundation closed its doors.

Donna Libretti Cooke similarly worked to bring Lazarex into her pharma oncology organization, yet final decision-makers faced difficulty reconciling these services within established procurement and compliance processes.

These systems were built for different purposes. Procurement processes, RFIs, and complex contract structures were designed primarily for large technology vendors or operational service providers, not for community-based nonprofit organizations that deliver patient support services. When these frameworks are applied to nonprofits, unintended barriers emerge.

The result is a structural gap: Nonprofit organizations with deep expertise in patient support are often unable to integrate efficiently into clinical trial operations, even when all parties recognize the potential benefit to participants.

The Operational Gap: Support Exists, But Sponsors Can’t Access It

The needs of many clinical trial patients go far beyond financial constraints. It can change the entire direction of your life, and you will deal with the consequences of it forevermore. Several nonprofit patient advocacy groups (PAGs) provide dynamic, comprehensive wrap-around services, including Patient Advocate Foundation, Family Reach, CancerCare, and PAN Foundation, with hands-on financial paperwork support, emergency travel assistance, emotional and caregiver support, and even pet care.

PAGs are ready and able to serve clinical operations in large pharma, but operational and structural barriers prevent a turnkey connection. Bargaining should not be part of the plan. There should be an actual plan.

Clinical operations teams understandably lack experience contracting with PAGs and nonprofits. When they encounter this need, they naturally apply the tools they have: complex RFIs and 30+ page contract templates designed for sophisticated technology vendors with appropriate and long-standing compliance standards. Alternatively, clinical operations may redirect nonprofits to medical affairs/patient advocacy, which has its own established but different pathways for engaging patient advocacy organizations. They want to send any party with a service deliverable back to clinical operational support services. This creates a challenge for all parties who understand that trusted PAGs and nonprofits may be best positioned to engage patients and provide financial support services.

In addition to providing financial assessment and support, PAGs can also refer (not recruit) patients to clinical trials through their community connectivity. Services go unused because of contracting standards that need modernization. PAGs and nonprofits do not have the time or staff to be negotiated with, as they are often resource constrained.  In times when grant funds for philanthropic pursuits are tight, grants and sponsorships simply do not provide ample stability to ensure that a reliable wrap around services program can endure. Lack of consistency erodes community trust and is not an option for patient centered non-profits and PAGs.

They have trusted community and patient services that pharma needs now. Everyone knows that community engagement is critical for representation in clinical trials. PAGs do this for a living.

While compliance and clinical operations teams would benefit from IRB input on these partnership frameworks, proactive engagement frameworks in this area remain underdeveloped.

The challenge is that current clinical operations contracting and risk frameworks were designed for technology vendors - not for community-based patient support organizations.

What Success Looks Like

Imagine a trial where a participant facing sudden eldercare responsibilities can access emergency support within 48 hours, get a ride to the trial site, and have a hot meal delivered on the evening of their clinical trial travel — not through bureaucratic approval chains, but through direct, pre-established pharma and nonprofit partnerships with adaptive funding. Where budget flexibility allows mid-trial adjustments based on actual participant needs rather than six-month-old projections. Where a participant's unexpected transportation challenge or childcare crisis doesn't become a reason to drop out, because responsive support systems are already in place.

While current service providers are filling some of these gaps, nonprofits can provide enhanced comprehensive support with years of experience from empathetic patient navigators. Patient navigators develop personal one-on-one relationships with the patient/caregiver and can activate local resources such as community organizations, houses of worship, friends, and neighbors to help provide support services. Hence, the need exists for an operational model that enables sponsors to address participant needs dynamically while maintaining compliance, ethical standards, and operational feasibility.

The infrastructure exists for this whole-person support, but we need the operational framework to connect it to clinical trials in compliant, efficient ways that respect both participant dignity and sponsor requirements.

Summary And Next Steps

Next-generation participant support must recognize the iterative nature of life's disruptions and the ground truth for clinical trial participants throughout the trial — not just at enrollment with a one-dimensional static budget developed six months prior.

Recognize that addressing financial barriers alone is insufficient, we’re suggesting a Whole-Person Participant Support™ approach is needed, and nonprofits can help fill the void. The operational and contracting barriers raised here should prompt sponsors to pause, take note, and develop workable solutions like new contract templates for nonprofits. Engage stakeholders in honest, risk re-evaluating conversations.

What must underpin all these efforts? Elevate patient and participant voices and build trust as a strategic imperative. Make it front-and-center. Recognize that participants' needs are constantly evolving throughout the trial and that their participation is a full-time commitment that can result in hope and a chance at life. Next to the patient, the sponsor is the primary beneficiary of trial enrollment and retention. This has all of the makings of a perfect set up for whole-person support — if we can just find (or create) the path forward.

Authors’ note: This article is not meant to address any anti-kickback concerns with offering such support services. Despite clear industry guidance that coverage of a participant’s indirect costs do not raise concerns of undue influence, some sponsors are reluctant to provide because no explicit safe harbor from the Anti-Kick Statute and/or the federal beneficiary inducement civil monetary law exists just yet.

References:

1. Reviewing Research Participant Payments Through a Diversity Lens, JCS – Journal for Clinical Studies, Volume 16, Issue 2.
2. Use of Participant Compensation in U.S. Clinical Research Studies, Compensation Issue Brief Final.pdf, ASPE Office of Science and Data Policy, Issue Brief, July 2025
3. Improving Participant Experience: What is Preventing Time and Effort Payments to Participants? (WCG 2026 Trends & Insights Report – The challenges and opportunities shaping 2026).
4. Id. at 28.
5. Id. At 29.

About The Authors:

Donna Libretti Cooke, JD, is chief impact officer of IMPACTSPHERE CLINICAL LLC, a boutique advisory firm focused on clinical trial access, participant experience, and operational excellence. She advises life sciences organizations, startups, and solution providers on participant payment strategy, sponsor operating models, AI-enabled clinical solutions, and strategic partnerships.

A former Bayer director, Donna pioneered award-winning the Kits4Life program and continues to advance initiatives that reduce participant burden and expand access to research. She is a recognized thought leader in participant compensation and whole-person participant support approach, with published work and leadership roles across industry collaborations.

For more than a decade, Donna has served as a volunteer patient educator with The Women's Cancer Teaching Project, sharing her lived experience as a triple-negative breast cancer survivor with nursing and medical students to support the humanistic dimensions of clinical care.  Her experiences together inform her commitment to more equitable, compassionate, and participant-centered clinical trials.

Erin Miller serves as the deputy director of the ANGEL Center of Excellence for the Tigerlily Foundation. Her transition from a corporate marketing background at IBM to nonprofit leadership was driven by the loss of her beloved husband. Her life’s mission is to help others navigate their cancer journey.

Erin served in many capacities for two decades at the Lazarex Cancer Foundation, ultimately becoming the co-executive director of operations & development. Erin focused on removing barriers to clinical trial participation and equitable access to cancer care and resources. Through her thought leadership, she published several articles and held influential roles on national boards and steering committees.

At Tigerlily, Erin remains dedicated to transforming the patient journey by leveraging her expertise in program innovation and collaboration to empower the ANGEL Advocates on their own advocacy pathway. Tigerlily ANGELs are experts in policy, advocacy, peer navigation, and they advise industry on patient experience.

Jeanne M. Regnante, CEO and founder of Patient 3i, LLC, is a leader in patient-centered, equity-focused cancer research. Her work has shaped how patient organizations, health systems, life science companies, environmental groups, professional organizations, and community partners design equitable care approaches together. Jeanne is known for her spirited advocacy for patients and patient organizations. She has led influential, highly cited publications and multi-stakeholder initiatives that define operational best practices for increasing racial and ethnic minority participation in clinical research and drives ecosystem change to keep pace with innovation in cancer care. Jeanne translates real-world patient and caregiver experience and insights to directly inform pragmatic strategies which include health literacy, navigation services, and community leadership. She is currently working with NCI COE leaders to advance foundational, strategic alignment with community organizations which promises to strengthen impact and improve outcomes for medically underserved populations.