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Evaluation Live Stream

2025 PRIM&R Annual Conference

Emerging Challenges and Innovations in Research

Navigating Ethical Challenges

Regulatory Frameworks and Compliance

C01 - PLENARY: Ethical Considerations for Discontinued Clinical Trials and Programs

Friday, November 7, 2025
3:30 PM - 4:45 PM ET
Location: Ballroom II
Human Subject Research - HSR Thought Leader Series Call for Session Proposal - CSP Live Streamed Session Live Session Recorded CIP Accredited
CLICK HERE to view captioning for this session! 

In drug development, nearly 90% of clinical programs are discontinued before obtaining regulatory approval, often involving early termination of clinical trials due to pre-planned stopping rules or unforeseen developments. Such premature trial discontinuations create complex challenges that demand careful planning to fulfill both regulatory requirements and ethical obligations. As the risk of early trial termination grows, the need for transparency, proactive communication, and strategic readiness among all stakeholders becomes increasingly critical. This session will feature representatives from two biopharmaceutical companies who will share frameworks they have developed to manage clinical programs that end unexpectedly, providing practical guidance on navigating these difficult scenarios.

Learning Objectives:

  • Analyze the reasons for, and ethical implications of, prematurely discontinuing a clinical program or trial, with particular attention to informed consent, risk-benefit assessment, and shared responsibilities
  • Evaluate the key components and best practices for fulfilling post-trial commitments to participants receiving investigational products
  • Examine the operational and regulatory challenges researchers, industry, and IRBs face in providing continued access to investigational products after program discontinuation