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Recommended changes to oncology clinical trial design: revolution or evolution?

Recommended changes to oncology clinical trial design: revolution or evolution?

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Moving molecular targeted drug therapy towards personalized medicine: issues related to clinical trial design Dose-finding design using mixed-effect proportional odds model for longitudinal graded toxicity data in phase I oncology clinical trials.Towards using a full spectrum of early clinical trial data: a retrospective analysis to compare potential longitudinal categorical models for molecular targeted therapies in oncology.A phase II study of 2-methoxyestradiol (2ME2) NanoCrystal® dispersion (NCD) in patients with taxane-refractory, metastatic castrate-resistant prostate cancer (CRPC).Exposure-response analysis of rilotumumab in gastric cancer: the role of tumour MET expression Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection.Do single-arm trials have a role in drug development plans incorporating randomised trials?Randomized phase II designs.Issues in using progression-free survival when evaluating oncology products Comparison of power between randomized discontinuation design and upfront randomization design on progression-free survival.Is response rate increment obtained by molecular targeted agents related to survival benefit in the phase III trials of advanced cancer?Determinants of the recommended phase 2 dose of molecular targeted agents.On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies.Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

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Recommended changes to oncology clinical trial design: revolution or evolution?

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Recommended changes to oncology clinical trial design: revolution or evolution?

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Recommended changes to oncology clinical trial design: revolution or evolution?

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Recommended changes to oncology clinical trial design: revolution or evolution?

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J.EJCA.2007.09.011

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European Journal of Cancer

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Recommended changes to oncology clinical trial design: revolution or evolution?

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Carl C Peck

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Donald A Berry

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Gary B Gordon

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Gwen Fyfe

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Biomarkers and surrogate endpoints: preferred definitions and conceptual framework

Can the pharmaceutical industry reduce attrition rates?

Setting the bar in phase II trials: the use of historical data for determining "go/no go" decision for definitive phase III testing.

Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.

The ultimate model organism: progress in experimental medicine.

Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval.

Model-based drug development.

Angiogenesis inhibition as a therapeutic approach for inflammatory synovitis.

Rapamycin: something old, something new, sometimes borrowed and now renewed.

Design issues of randomized phase II trials and a proposal for phase II screening trials.

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