Framework
Whole-Person Participant Support™ Framework
A sponsor-embedded operating model that helps clinical trials address real participant burdens through adaptive support systems — including responsible engagement with nonprofit organizations.
"The clinical trials industry has long treated participant support as a line item. We believe it should be an operating model."
Co-developed by Donna Libretti Cooke with two industry colleagues.
The Problem
Why Static Reimbursement Fails Participants
Dynamic participant needs require connected support systems. The current model was designed for a different era.
Static Budgets
Fixed compensation structures cannot accommodate the dynamic and shifting nature of participant burden across a trial's lifecycle.
Reimbursement Gaps
Standard reimbursement models leave critical financial and logistical needs unaddressed, particularly for underserved populations.
Shifting Needs
Participant needs change over the course of a trial — support systems must be adaptive, not locked at protocol design.
Disconnected Nonprofits
Nonprofit organizations provide enormous value to patients daily, yet sponsors often lack efficient pathways to engage them operationally.
Site Friction
Administrative and operational complexity at the site level compounds participant burden and contributes to dropout and delay.
The Model
The WPPS™ Ecosystem
The WPPS™ ecosystem connects Sponsors, Sites, Participants, and Nonprofit Organizations through structured support delivery and trust bridges — with Whole-Person Participant Support at the center.
Implementation
Activating the WPPS™ Framework
Reframe Support
Move beyond static reimbursement to operational realities. Support should be iterative, financial, logistical, social, ethical, and compliant — not a one-time payment at visit completion.
Enable Partnerships
Create structured engagement between sponsors, sites, service providers, and nonprofit organizations with appropriate regulatory safeguards and compliance infrastructure.
Modernize Contracting
Develop simplified contract templates, proportionate diligence processes, and clearly defined service scopes that make sponsor-nonprofit collaboration operationally feasible.
Engage IRBs Earlier
Protocol development should include considerate adaptive mechanisms from the outset. IRB engagement at finalized budgets is too late — participants pay the price.
Activating WPPS™ with NonProfits: four dimensions — Reframe Support, Enable Partnerships, Modernize Contracting, Engage IRBs Earlier.
The Impact
When Support Systems Work
The WPPS™ framework is designed to create measurable improvements across the entire trial ecosystem.
Better Retention
Faster Enrollment
Reduced Burden
Stronger Trust
Greater Representation
Lower Site Strain
"Participant support should not be an afterthought."
The future of clinical trials includes smarter sponsor + nonprofit collaboration. Help pilot the WPPS™ Framework.
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