Which criterion justifies early termination of a trial?

• A. Termination based on sponsor preference
• B. Clear evidence of benefit or harm identified by an independent data monitoring committee
• C. Recruitment goals achieved without regard to data
• D. Final analysis pending

Answer: (B)

When a trial is stopped early, the primary concern is participant safety and the credibility of the results. An independent data monitoring committee (or DSMB) reviews accumulating interim data and, if there is clear evidence of benefit or harm, can recommend stopping the trial before its planned end. This approach uses objective data and pre-specified stopping rules to protect participants and avoid exposing them to unnecessary risk or denying them a potentially beneficial treatment. Stopping for sponsor preference, simply because recruitment goals were met, or waiting for final analyses to be completed before making a decision would undermine trial integrity and could bias the results. Therefore, the criterion that justifies early termination is clear evidence of benefit or harm identified by an independent monitoring body.