Early termination

Careful consideration and thorough analysis need to be completed before a decision about whether to terminate a trial early is made. Once a decision has been made by the Trial Steering Committee (TSC) to terminate the clinical trial early, the following needs to happen:

Consultation and approval

• Sponsor: Inform the trial sponsor to seek input and approval.
• Human Research Ethics Committee (HREC): Obtain approval for early termination.
• Regulatory and industry bodies: Where applicable obtain the necessary approvals from relevant regulatory bodies and industry.

Communication

• Trial sites: Notify, where applicable, all participating trial sites and the reasoning for early termination. Implement site closure procedures, including return of study material and investigational products and financial settlements. Conduct a final monitoring visit to ensure proper site closure and data collection.
• Participants: Communicate to trial participants, informing them of the early termination, providing reasons and any necessary follow-up care, such as counselling and addressing any questions or concerns they may have.
• Collaborators: Inform all collaborators and funding bodies about the decision.
• Vendors: Address any contracts with vendors providing services for the trial.

Documenting and reporting

• Document in detail the reasons for early termination.
• Submit any necessary reports, such as final safety reports.
• Ensure all data collected up to the termination point is accurately recorded, reported and stored.
• Conduct a final data analysis to summarise findings and report any trends or conclusions.
• Conduct a post-trial review to discuss and document the lessons learned and how to prevent issues in the future.