Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials
2001

Drug Activity in Cancer Models and Clinical Trials

Sample size: 564 publication Evidence: moderate

Author Information

Author(s): Johnson J I, Decker S, Zaharevitz D, Rubinstein L V, Venditti J M, Schepartz S, Kalyandrug S, Christian M, Arbuck S, Hollingshead M, Sausville E A

Primary Institution: Developmental Therapeutics Program, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute

Hypothesis

Does drug activity in preclinical models correlate with clinical trial outcomes?

Conclusion

The study found that in vivo activity in preclinical models does not closely correlate with clinical results, but certain predictors can indicate potential success in clinical trials.

Supporting Evidence

  • In vivo activity did not closely correlate with clinical results for many agents.
  • Hollow fibre activity was a better predictor of xenograft activity than other methods.
  • 56% of compounds with high potency in cell line screens were active in multiple hollow fibres.

Takeaway

Scientists tested many cancer drugs in lab models and found that some predictions about how well they work in people were not accurate, but some tests helped identify promising drugs.

Methodology

The study analyzed the activity of 39 agents in preclinical models and their correlation with Phase II clinical trial results, as well as the predictive value of hollow fibre assays.

Limitations

The correlation between preclinical and clinical results was not strong, indicating limitations in the predictive power of current models.

Statistical Information

P-Value

p<0.0001

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.1054/bjoc.2001.1796

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