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. 2011 Nov 1;17(21):6634-40.
doi: 10.1158/1078-0432.CCR-11-1105.

Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics

Howard I Scher  1 , Shelley Fuld Nasso, Eric H Rubin, Richard Simon
Affiliations

Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics

Howard I Scher et al. Clin Cancer Res. .

Abstract

A critical challenge in the development of new molecularly targeted anticancer drugs is the identification of predictive biomarkers and the concurrent development of diagnostics for these biomarkers. Developing matched diagnostics and therapeutics will require new clinical trial designs and methods of data analysis. The use of adaptive design in phase III trials may offer new opportunities for matched diagnosis and treatment because the size of the trial can allow for subpopulation analysis. We present an adaptive phase III trial design that can identify a suitable target population during the early course of the trial, enabling the efficacy of an experimental therapeutic to be evaluated within the target population as a later part of the same trial. The use of such an adaptive approach to clinical trial design has the potential to greatly improve the field of oncology and facilitate the development of personalized medicine.

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Conflict of interest statement

Disclosure of Potential Conflicts of Interest

No potential conflicts of interest were disclosed.

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References

    1. Roberts SA, Karnes EK, Allen JD, Benner JS, Sigal EV, McClellan MB. Achieving the goals of effective, safe, and individualized cancer care. Clin Cancer Res. 2011;17:XX–XX. - PubMed
    1. Turteltaub KW, Davis MA, Burns-Naas LA, Lawton MP, Clark AM, Reynolds JA. Identification and elucidation of the biology of adverse events: the challenges of safety assessment and translational medicine. Clin Cancer Res. 2011;17:XX–XX. - PubMed
    1. Cleeland CS, O'Mara A, Zagari M, Baas C. Integrating pain metrics into oncology clinical trials. Clin Cancer Res. 2011;17:XX–XX. - PubMed
    1. Schilsky RL, Fenton-Ambrose L, Freedman J, Buetow K, Friend S. Using patient-initiated study participation in the development of evidence for personalized cancer therapy. Clin Cancer Res. 2011;17:XX–XX. - PubMed
    1. Rubin EH, Anderson KM, Gause CK. The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development. Cancer Discovery. 2011;1:17–20. - PubMed

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