By Erik Yorke  

August 28, 2025 | In an environment where clinical trial budgets are scrutinized and timelines compressed, the human and operational toll of cancelled studies poses a serious threat. It undercuts site stability, strains patient engagement, and jeopardizes future collaboration. A recent SCOPE 365 ClinEco Connect session convened industry veterans across sites, sponsors, and CROs to seek a solution. The group found that meaningful industry-wide improvements are possible—but they demand intentional dialogue, shared resources, and an equitable rethink of risk distribution.  

Moderated by Carlos Orantes, chief executive of Alcanza Clinical Research, the live conversation spotlighted how these disruptions ripple through the clinical landscape and offered actionable paths toward mitigation.  

Financial and Reputational Fallout  

Stakeholders painted a sobering picture. Sites shared how they often surge resources—hiring staff, prepping budgets, and gearing up for patient engagement—only to see studies abruptly canceled due to shifting sponsor strategies, regulatory delays, or reallocated budgets.   

“We’re dancing in the dark. The variables are 100% out of our control,” said Deena Bernstein, Vice President, Site Choice, Account Management at Transformative Pharmaceutical Solutions.  

The fallout extends beyond delay. Sites recounted that standard startup payments rarely cover the real cost of readiness—including opportunity costs—leaving them absorbing hefty losses. In many cases, staffing contracts become burdensome, while patient goodwill evaporates when anticipated trials fall through, undermining recruitment trust for future studies.  

Sponsors and CROs countered that cancellations are seldom malicious; they’re often mandated by business reprioritization or pipeline shifts. Still, a lapse in compensation—or even in partially compensating sunk efforts—creates friction and risk across all parties.  

Contracting and Creative Compensation  
  
Participants spotlighted a major shortfall: contracts seldom include clauses that shield sites from cancellation exposure. Where cancellation fees exist, they’re frequently rejected by CROs or deemed too costly by sponsors. Larger institutions sometimes succeed in negotiating these protections, but small or independent sites remain vulnerable.  

However, a glimmer of innovation emerged: some sponsors are embracing more flexible models. One example discussed was offering a "site validation payment" or issuing a reimbursement letter for efforts conducted before a Clinical Trial Research Agreement (CTRA) is finalized—mechanisms lauded by attendees as steps in the right direction.  

Building Toward Alignment  
  
As the discussion shifted toward solutions, several themes emerged:  

• Transparency Is Key: Consensus grew that early, clear communication surrounding potential cancellations helps sites manage staffing, budgets, and patient relations more effectively.  

• Supporting Documentation: Sites agreed on the value of policy letters and budget documentation evidencing true startup expenditure—not just for internal clarity, but to strengthen reimbursement claims.  

• Standardized Tracking: The group recommended developing uniform tools or templates to record cancellation-related costs; such resources could bolster advocacy across sponsors and CROs.  

• Flexible Financial Structures: Ideas like prepayments, budget rollover mechanisms, and milestone-based compensation surfaced as possible guardrails—though attendees noted that these carry their own logistical and accounting complexities.  

Takeaway: A Collective Duty  
  
In closing, Orantes crystallized the session’s tone: “Don’t assume somebody else is taking care of it. This industry is about collaboration, and a rising tide lifts all boats. We’ve got to speak up and do something about it—together.”  

Participants agreed: although cancellations are a painful but familiar barrier, they also present an opportunity. By fostering empathy and cooperation in contract design—and by framing mitigation tools collaboratively—stakeholders can protect site operations, preserve trust with patients, and streamline trial resilience.  

This discussion was part of the SCOPE 365 ClinEco Connect series. To explore upcoming sessions or review summaries from past events, visit www.clineco.io/meetups.