# Independent replication of the key experiment before first-in-human academic trials

Source: https://onco.cc/ideas/idea-tr2-replication-before-ind/  
OnCo record `idea-tr2-replication-before-ind` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Before a new cancer drug from a university is given to people, a separate laboratory should have repeated the main experiment showing it works.

## Summary

Industry routinely replicates academic findings internally before investing, and reports that a majority fail. Academic and small-biotech investigational new drug applications rest on the originating lab's data. Requiring, or funding through translational programmes, an independent replication of the pivotal efficacy experiment (in the same model, blinded, pre-registered) before first-in-human dosing would catch non-reproducible programmes before patients are exposed.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: At least a quarter of pivotal efficacy experiments will fail independent replication, and programmes whose experiments replicated will show higher early clinical activity than historical academic-origin programmes.
- Rationale: Amgen and Bayer reported that only 11 to 25% of landmark preclinical findings reproduced in their hands; nothing in the regulatory pathway checks this for academic sponsors.
- Proposed test: Fund replication for twenty academic programmes approaching investigational new drug submission through an existing translational accelerator; report replication rate and subsequent clinical outcomes.
- Maturity: speculative
- Actor: regulator

## Sources

- Bottleneck evidence (Preclinical results do not reproduce): Errington et al., Investigating the replicability of preclinical cancer biology (eLife 2021): https://doi.org/10.7554/eLife.71601

## Connected records

- ideas: [Funders set aside a fixed share of budget for independent replication](https://onco.cc/ideas/idea-tr2-replication-set-aside/), [Multi-laboratory preclinical trials as the standard for go/no-go decisions](https://onco.cc/ideas/idea-tr2-multilab-preclinical/), [Paid independent statistical review for preclinical papers that inform trials](https://onco.cc/ideas/idea-tr2-paid-statistical-review/), [Top journals require an independent lab to reproduce key findings before publication](https://onco.cc/ideas/idea-tr2-two-lab-rule/)
- bottlenecks: [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/), [The valley of death between lab and product](https://onco.cc/bottlenecks/b-translational-valley/)

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