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Ideas
Pre-register animal efficacy studies like clinical trials

Pre-register animal efficacy studies like clinical trials

Clinical trials must be registered before they start so that failures cannot be hidden. Animal studies used to justify human trials should follow the same rule.

Overview Connected5

Overview

Publication bias and flexible analysis inflate preclinical effect sizes; systematic reviews repeatedly find that animal efficacy is overstated relative to later clinical results. A registry requiring the protocol, sample size, randomisation, blinding and primary endpoint before pivotal in vivo efficacy studies, enforced by funders and journals, would make preclinical evidence auditable. The ARRIVE guidelines exist but are advisory.

Hypothesis

Pre-registered in vivo efficacy studies report smaller average effect sizes and higher replication rates than unregistered studies, and pre-registration reduces the rate of failed phase 2 trials in programmes that relied on them.

Rationale

Registration reduced positive-result rates in clinical cardiology trials, an effect large enough to be visible; the same incentives operate preclinically with weaker safeguards.

Proposed test

A funder mandates registration for pivotal in vivo studies in its portfolio for three years and compares effect sizes and independent replication with a matched unregistered portfolio.

Maturity

speculative

Who acts

policy

Cost to try

Small (under $1M)

Years to first evidence

4

Bottlenecks it attacks

Lab models that fail to predict what happens in patients · Nine in ten cancer drugs that work in mice fail in humans. Our models are the reason.
Preclinical results do not reproduce · Fewer than half of landmark cancer biology findings reproduce when someone else tries.
Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.

Connected

Similar pages

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institutions

Cancer Research UK National Cancer Institute (NIH)

bottlenecks

Failures are hidden Lab models that fail to predict what happens in patients Preclinical results do not reproduce

ProvenanceLast edited 2026-09-08 · Jude Gomila · Ideas wave · diff · file

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ARRIVE guidelines

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National Cancer Institute (NIH)
Cancer Research UK

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