Dose optimization during drug development: whether and when to optimize

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Augmenting randomized clinical trial data with historical control data: Precision medicine applications

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Clinical Benefit Scales and Trial Design: Some Statistical Issues

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A Problematic Biomarker Trial Design

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Moving Molecular Profiling to Routine Clinical Practice: A Way Forward?

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Single-Arm Phase II Trials of Combination Therapies: A Review of the CTEP Experience 2008–2017

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Two-by-Two Factorial Cancer Treatment Trials: Is Sufficient Attention Being Paid to Possible Interactions?

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Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements

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RE: Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-Analysis of Clinical Trials Leading to FDA Approval

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Design Issues in Randomized Clinical Trials of Maintenance Therapies

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Response Get access

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A Model Too Far Get access

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Statistical and Practical Considerations for Clinical Evaluation of Predictive Biomarkers Get access

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Implementation of Timeline Reforms Speeds Initiation of National Cancer Institute–Sponsored Trials Get access

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Randomized Clinical Trials With Biomarkers: Design Issues Get access

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Early Average Change in Tumor Size in a Phase 2 Trial: Efficient Endpoint or False Promise? Get access

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Nontoxicity Endpoints in Phase I Trial Designs for Targeted, Non-Cytotoxic Agents Get access

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Analyzing Health Surveys for Cancer-Related Objectives Get access

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The Limited Precision of Phase I Trials Get access

Severed Myelosuppression Resulting From Concurrent Administration of Granulocyte Colony-Stimulating Factor and Cytotoxic Chemotherapy Get access