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How can we improve clinical trials?

Nature Clinical Practice Oncology volume 4, pages 206–207 (2007)Cite this article

It is widely understood that drug development in oncology, as elsewhere in medicine, is typically a lengthy and extremely expensive process. Even so, it is also a risky business with only about 8% of the oncology agents that complete phase I testing ultimately achieving licensing.1 Improved strategies are needed to shorten the time required to identify genuine therapeutic advances and make them available to patients. More reliable prediction of meaningful activity at an intermediate stage and more accurate and comprehensive estimation of likely toxicity in typical clinical use would improve the success rate and reduce the time, effort and cost associated with the development of unsuccessful agents. There are a number of strategies that have been recommended to improve the new agent development process,2 and some less obvious ones that I would like to propose (Supplementary table online).

The classic paradigm of cancer drug development is a legacy of the early era of discovery and investigation of empirically identified cytotoxics.3 The first phase II trials were designed for populations with advanced disease expected to have a grim prognosis, and aimed to identify a minimal or modest signal of activity or to minimize exposure to drugs that were generally highly toxic. Although phase II design has evolved to a certain extent, and typically includes sophisticated pharmacodynamic and target effect assessment, most studies still recruit rather selective cohorts of around 40–50 subjects from 1 or 2 major referral centers. These days the governing concern is most often speed.

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References

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  1. National Cancer Research, Network Coordinating Centre, Cookridge Hospital, Hospital Lane, Leeds LS16 6QB, UK r.kaplan@ncrn.org.uk

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  1. RS Kaplan is Associate Director of the National Cancer Research Network, based in Leeds and London, UK.,

    Richard S Kaplan

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  1. Richard S Kaplan
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The author declares no competing financial interests.

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Kaplan, R. How can we improve clinical trials?. Nat Rev Clin Oncol 4, 206–207 (2007). https://doi.org/10.1038/ncponc0775

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