Clinical Trial Rescue Studies:
Assessing recoverability and
designing a proportionate
response

This whitepaper provides a structured approach to determining when a trial genuinely requires rescue, whether it remains recoverable and what proportionate response should be taken. It explores how sponsors can contain immediate risks, reconstruct what happened, identify verified causes and assess the impact on participants, data and the scientific objectives of the study.

This Whitepaper will provide you with:

• A framework for identifying when a trial requires rescue - understand when problems have moved beyond routine study management and require a structured intervention.
• Practical steps for stabilising a compromised trial - learn how to contain immediate risks, establish the trial's actual status and distinguish observable problems from their underlying causes.  
• A structured approach to assessing recoverability - evaluate whether affected data remain reliable, whether the scientific question can still be answered and whether effective trial control can realistically be restored. 
  
• Guidance for designing proportionate rescue responses - explore cause-led approaches to recruitment, site performance, data management, protocol deviations, vendor performance and other common trial challenges 
  
• Key governance and transition considerations - understand how accountability, decision rights, provider transitions and documentation can be managed during rescue. 
  
• A framework for testing whether rescue actions are working - learn why completing corrective actions is not enough and how effectiveness should be demonstrated against measurable outcomes. 
  
• A decision framework for what comes next - understand when the evidence supports continuing, modifying, partially salvaging, suspending or terminating a trial.