What safeguards exist to prevent fraud in clinical trials?

• A. Randomization and blinding only.
• B. Independent monitoring, data verification, trial registration, peer review, and enforcement of good clinical practice standards.
• C. Self-reporting by investigators without verification.
• D. Public voting on trial outcomes.

Answer: (B)

Safeguards against fraud in clinical trials come from independent oversight, rigorous data handling, and transparent reporting. Independent monitoring by an external entity helps detect irregularities during the trial, ensures the protocol is followed, and flags potential misconduct early. Data verification, including checking that reported results match original source records and conducting audits, protects against fabrication or manipulation of data. Trial registration creates a public record of planned methods and endpoints, making selective reporting more difficult and allowing others to compare what was planned with what is reported. Peer review provides external critique of methods and findings, helping to identify errors, biases, or fraudulent activity. Enforcing good clinical practice standards ties all aspects of trial conduct to ethical and scientific quality, with established guidelines for documentation, consent, risk management, data integrity, and accountability. Together, these layers create ongoing accountability and credible results.

While randomization and blinding help reduce bias in results, they do not by themselves establish safeguards against fraud. Self-reporting without verification lacks independent checks, and public voting on outcomes is not how trial results are validated.