# Run the mouse or organoid trial at the same time as the human trial

Source: https://onco.cc/ideas/idea-bio1-co-clinical-avatar-trials/  
OnCo record `idea-bio1-co-clinical-avatar-trials` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Instead of testing a drug in lab models first and hoping the results carry over, build the same models from trial participants and run both experiments in parallel to see how well the models predict.

## Summary

Co-clinical trials generate patient-derived organoids or xenografts from enrolled participants and treat them with the trial regimen, with model results locked and blinded until the clinical readout. This produces a prospective, unbiased estimate of model predictive value, which the field currently lacks, and gives a resource for studying the responders and non-responders.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Blinded, prospectively locked avatar predictions achieve a positive predictive value above 70 percent for clinical response in at least one modality, establishing which model system deserves decision-making weight.
- Rationale: Retrospective concordance figures for organoids are encouraging but subject to selection and reporting bias. Only prospective locking measures true predictive value, as was done for imaging biomarkers.
- Proposed test: Attach an avatar sub-study to three ongoing phase 2 trials in different tumour types with pre-registered analysis; report predictive values regardless of direction.
- Maturity: early-clinical
- Actor: research

## Sources

- Bottleneck evidence (Lab models that fail to predict what happens in patients): Wong, Siah & Lo, Estimation of clinical trial success rates (Biostatistics 2019): https://doi.org/10.1093/biostatistics/kxx069

## Connected records

- ideas: [Patient-derived organoids to pick ADC payloads](https://onco.cc/ideas/idea-organoid-guided-adc/)
- technologies: [Functional (ex vivo) drug testing](https://onco.cc/technologies/functional-drug-testing/), [Patient-derived organoids](https://onco.cc/technologies/organoids/), [Patient-derived xenografts](https://onco.cc/technologies/pdx-models/)
- companies: [Champions Oncology](https://onco.cc/companies/champions-oncology/), [Xilis](https://onco.cc/companies/xilis/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Lab models that fail to predict what happens in patients](https://onco.cc/bottlenecks/b-preclinical-models/)
- key papers: [Estimation of clinical trial success rates and related parameters](https://onco.cc/key-papers/paper-wong-biostatistics/)

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