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Practical Considerations for Adaptive Trial Design and Implementation

Part of the Statistics for Biology and Health Book Series

Editors: He, Weili; Pinheiro, José; Kuznetsova, Olga M.

DOI: 10.1007/978-1-4939-1100-4

ISBN: 978-1-4939-1099-1

Publisher: Springer New York - Springer Journals

Aug 30, 2014

1 - 10 of 20 Chapters

LitStream

The Need for and the Future of Adaptive Designs in Clinical Development

Chuang-Stein, Christy; Bretz, Frank

Pages: 3 –23

[There has been much progress in the development and implementation of adaptive designs over the past 20 years. A major driver for this class of novel designs is to increase the information value of clinical trial data to enable better decisions, leading to more efficient drug development...
LitStream

Regulatory Guidance Documents on Adaptive Designs: An Industry Perspective

Pinheiro, José

Pages: 25 –41

[Adaptive designs have the potential to be a transformative methodology in clinical drug development, but acceptance by regulatory agencies is a prerequisite for their broader adoption and success, especially in the context of confirmatory studies. Both FDA and EMA have published guidance...
LitStream

A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences

Wang, Sue-Jane

Pages: 43 –68

[Fixed design confirmatory trials rely on emerging and reliable prior data and knowledge to provide necessary assumptions about the key design parameters including nuisance parameters. Traditionally, a fixed design has been the gold standard for its simplicity, validity, and ability to provide an...
LitStream

Considerations and Optimization of Adaptive Trial Design in Clinical Development Programs

Krams, Michael; Dragalin, Vladimir

Pages: 69 –90

[Although the efficiency of adaptive design on the trial level is well recognized, its impact is even greater when applied at the program or portfolio level. Besides its simplest form of sample size reestimation or early stopping in a given trial, the adaptive design achieves efficiency by...
LitStream

Optimal Cost-Effective Go–No Go Decisions in Clinical Development

Chen, Cong; Beckman, Robert A.; Sun, Linda Z.

Pages: 91 –113

[In late-stage drug development, drug developers have to make two critical Go–No Go decisions. The first one is whether to proceed to the definitive Phase III investigation after a Phase II proof-of-concept (POC) trial. The second one is whether to stop a Phase III confirmatory trial for futility...
LitStream

Timing and Frequency of Interim Analyses in Confirmatory Trials

Anderson, Keaven M.

Pages: 115 –123

[In many pivotal clinical trials, timing and frequency of interim analyses are important for ethical treatment of patients and for practical and regulatory purposes. It is often desirable to evaluate a large trial of a new treatment that has some safety risk in order to stop or modify the trial...
LitStream

Approaches for Optimal Dose Selection for Adaptive Design Trials

Lawrence, David; Bretz, Frank

Pages: 125 –137

[Adaptive designs use accumulating data to modify in a prospectively planned manner certain design aspects of a clinical study without undermining its validity and integrity. The aim of this chapter is to review adaptive design approaches for dose finding and optimal dose selection and to...
LitStream

A Review of Available Software and Capabilities for Adaptive Designs

Tymofyeyev, Yevgen

Pages: 139 –155

[This chapter provides a brief review of methodologies and software solutions for several types of adaptive designs: the traditional and adaptive group sequential designs including sample size reestimation, multistage adaptive designs with arm and subpopulation selection at interim analyses, and...
LitStream

Randomization Challenges in Adaptive Design Studies

Kuznetsova, Olga M.

Pages: 157 –181

[Adaptive design studies often face randomization challenges. Adaptive dose-ranging studies require randomization techniques that, in a small cohort, approximate reasonably well an inconveniently skewed allocation ratio to several treatment arms. When a small interim analysis sample needs to be...
LitStream

Response-Adaptive Randomization for Clinical Trials

Zhang, Lanju; Rosenberger, William F.

Pages: 183 –199

[Response-adaptive randomization in clinical trials uses accumulated patient response data to adjust the allocation probability for the next patient, so that a particular objective, for example, more patients assigned to the better performing treatment arm, can be achieved. This ethically...

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