What is essential for ensuring that interim analyses in clinical trials are conducted ethically and maintain trial integrity?

Question

BlackTom AI · Accepted Answer

In clinical trials, the timing and conduct of interim analyses must be tightly governed to protect participants and preserve the integrity of the study.
Option a: 'They are conducted to influence regulatory decisions by presenting selective results.' This implies cherry-picking data or manipulating results for regulatory leverage, which is unethical and undermines trial integrity. Interim analyses should not be used to push favorable outcomes at the expense of transparency or safety.
Option b: 'They must be prospectively planned and detailed in the trial protocol to prevent bias.' This statement aligns with best practices: pre-specifying when and how interim analyses occur, along with stopping rules and statistical boundaries, helps avoid ad hoc decisions and preserves statistical validity and ethics. It directly supports trial integrity by reducing bias and ensuring consistency.
Option c: 'They can be started based on recommendations from any member of the trial team.' Allowing arbitrary or informal initiation from arbitrary team members risks subjective influences, inconsistent application, and potential bias. Interim analyses should follow a predefined plan, not be driven by individual opinions.
Option d: 'They are primarily used to adjust the trial design based on external factors unrelated to the trial data.' Interventions based on external factors outside the data could compromise objectivity and inflate type I error. Interim analyses are intended to evaluate accumulating trial data to protect participants and answer the research question, not to react to unrelated externalities.

MPS5104 S1 2025 PA Clinical Trials Quiz 2025

What is essential for ensuring that interim analyses in clinical trials are conducted ethically and maintain trial integrity?

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