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Clinical trials are being compromised by poor animal study design and reporting, says a new study published in the open access journal PLOS Biology.

The review analyzed the descriptions of animal studies found in "investigator brochures," the documents used by regulatory authorities and ethics committees to assess which drugs should move to testing in patients. These brochures are crucial to the decision of which drugs move into clinical trials.

However, based on the assessment, which included documents from three German medical research centers, the study authors recommend stricter standards for the design and reporting of the animal studies.

The analysis revealed that:

  • Fewer than 20% of investigator brochures referenced animal studies that had been through the peer-reviewed publication process.
  • Fewer than 20% of animal studies included references to techniques that reduce the effects of bias, like randomization blinding or sample size calculation.
  • Only 4% of animal studies reported failure of a treatment, suggesting that less flattering stories are being left out of investigator brochures.

"Animal research should better differentiate between explorative and confirmatory study designs. When explorative animal research finds promising results one should apply more confirmatory designs for those animal studies that aim to inform and justify a clinical trial. The more translational animal research becomes, the more robust and reproducible should the study design be," Dr Daniel Strech, professor for bioethics at Hannover Medical School and senior author of the study, explained to ALN.

Participating authors for this study worked at Hannover Medical School in Germany and McGill University.

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