Forensic audits for clinical trials

Updated: 2023.07.18 2Y ago 1 sources
Clinical‑trial literature may contain a non‑trivial share of fabricated or irreproducible trials, so routine forensic audits (random raw‑data checks, statistical integrity screening and mandatory provenance deposits) should be implemented as a condition of publication and regulatory acceptance. Such audits would combine statistical forensics with mandatory access to trial records to catch fabricated datasets and prevent sham trials from informing care. — If adopted, forensic auditing would shift where trust is placed—from reputation and peer review to verifiable data provenance—and could materially change drug approvals, clinical guidelines and patient safety.

Sources

Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed?
2023.07.18 100% relevant
Nature cites John Carlisle’s estimate and multiple investigations reporting that up to ~25% of trials in some fields may be problematic, and reports researchers urging stronger scrutiny and checks by journals and regulators.
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