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| Language | English |
| Format | PDF (Premium Digital) |
| Ownership | Permanent download — yours forever |
Practical Considerations for Adaptive Trial Design and Implementation by Weili He
This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues facedin trial implementation.
Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
| SKU | NLS9781493955398 |
|---|---|
| ISBN 13 | 9781493955398 |
| ISBN 10 | 149395539X |
| Author | Weili He |
| Series | Statistics For Biology And Health |
| Condition | New |
| Binding Type | Paperback |
| Publisher | Springer-Verlag New York Inc. |
| Year published | 2016-09-22 |
| Number of pages | 416 |
| Cover note | Book picture is for illustrative purposes only, actual binding, cover or edition may vary. |
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"Switched from Kindle to these PDFs. Same book, but I actually OWN it now. No monthly fees, no app required. Worth every penny."
"Kindle Unlimited kept raising prices. This is a one-time purchase and the file is permanently on my iPad. Best decision I've made for my reading habit."
"I compared Kindle vs this store. Kindle is cheaper monthly but you don't own anything. Here I paid once and the PDF is mine for life. Highly recommend."
"Left Kindle behind after they removed a book I was reading mid-series. With this PDF, nobody can take it away from me. True ownership feels good."
"Was skeptical about paying $18.95 when Kindle shows $3.99, but then I did the math — Kindle Unlimited is $143/year! This is way better value long term."
"Love that I can read this on any device without installing the Kindle app. The PDF works on my laptop, phone, and tablet seamlessly. So much freedom."
"My Kindle subscription was getting expensive. Switched to buying PDFs here and I'm saving money while actually building a permanent digital library I control."
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