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Clinical trials design review

Rebecca Kirk & Lisa Hutchinson


Nature Reviews Clinical Oncology 9, 185-186 (2012)

Adaptive clinical trials in oncology

Donald A. Berry


Nature Reviews Clinical Oncology 9, 199-207 (2012)

The size, length and cost of phase III clinical trials are prompting oncology researchers and pharmaceutical companies to look for other options. This Review outlines adaptive clinical trial designs that can address many questions at once. A wholly new paradigm for drug development exemplifying personalized medicine is evinced by an adaptive trial called I-SPY2, in which drugs from many companies are evaluated in the same study and are matched with their biomarker signatures.

Role of randomized phase III trials in an era of effective targeted therapies

Manish R. Sharma & Richard L. Schilsky


Nature Reviews Clinical Oncology 9, 208-214 (2012)

If a targeted therapy demonstrates convincing efficacy in early clinical testing, can randomized phase III trials be avoided? Sharma and Schilsky discuss when it is reasonable to consider foregoing randomized phase III trials before drug approval and also highlight the caveats. They explore the consequences of such an approach and propose criteria that the drugs must meet to be approved without a phase III trial.

Drug development and clinical trials—the path to an approved cancer drug

Eric H. Rubin & D. Gary Gilliland


Nature Reviews Clinical Oncology 9, 215-222 (2012)

The current system for the development of anticancer drugs is not fit for purpose. In this Review article, this system is examined from the perspective of the drug company, offering a fresh look at development from target identification up to registration.

Use of neoadjuvant data to design adjuvant endocrine therapy trials for breast cancer

Rodrigo Goncalves, Cynthia Ma, Jingqin Luo, Vera Suman & Matthew James Ellis


Nature Reviews Clinical Oncology 9, 223-229 (2012)

Is there a precise end point that could enable us to compare neoadjuvant and adjuvant endocrine therapy outcomes? A reliable short-term surrogate to assess the potential of endocrine drugs in the adjuvant setting? In this Review, Goncalves et al. summarize the studies in which the proliferation marker Ki 67, measured during neoadjuvant treatment, has predicted accurately and consistently the results of much larger studies in the adjuvant setting.

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