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Re-Engineering Clinical Trials: Best Practices , Schuler, Buckley.=
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- PublishedOn
- 2015-01-08
- ISBN
- 9780124202467
- EAN
- 9780124202467
- Publication Year
- 2014
- Type
- Textbook
- Format
- Hardcover
- Language
- English
- Publication Name
- Re-Engineering Clinical Trials : Best Practices for Streamlining the Development Process
- Item Length
- 9in
- Publisher
- Elsevier Science & Technology
- Item Width
- 6in
- Number of Pages
- 360 Pages
關於產品
Product Information
The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. Highlights the latest paradigm-shifts and innovation advances in clinical research Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more
Product Identifiers
Publisher
Elsevier Science & Technology
ISBN-10
0124202462
ISBN-13
9780124202467
eBay Product ID (ePID)
207807860
Product Key Features
Publication Name
Re-Engineering Clinical Trials : Best Practices for Streamlining the Development Process
Format
Hardcover
Language
English
Publication Year
2014
Type
Textbook
Number of Pages
360 Pages
Dimensions
Item Length
9in
Item Width
6in
Additional Product Features
Lc Classification Number
Rm301.27
Reviews
"...a good overview of problems facing the pharmaceutical industry in the design and conduct of clinical trials, especially within the current regulatory framework. Score: 74 - 3 Stars" -- Doody's, "...a good overview of problems facing the pharmaceutical industry in the design and conduct of clinical trials, especially within the current regulatory framework. Score: 74 - 3 Stars"-- Doody's, Re-Engineering Clinical Trials
Table of Content
Section 1: Why Does the Industry Need a Change? 1. Why is our industry struggling? 2. What are the current main obstacles to reach drug approval? 3. Japan: An opportunity to learn? 4. The "Clinical Trial App" Section 2: What Does Our Industry and What Do Others Do 5. What does "re-engineering" mean in our industry? 6. How can the Innovative Medicines Initiative help to make drug development more efficient? 7. Experiences with Lean and Shopfloor Management in R&D in other branches 8. Well-known methodologies, but not in our world: FMEA Section 3: Where to Start: The Protocol 9. No patients, no data: Patient recruitment in the 21st century 10. The impact of bad protocols 11. Data mining for better protocols 12. It is all in the literature 13. What makes a good protocol better? 14. The Clinical Trial Site Section 4: Alternative Study Designs 15. Do we need new endpoints? Surrogate and bio-marker 16. On the measurement of the disease status in clinical trials: lessons from MS 17. Generating evidence from historical data using "robust prognostic matching": Experience from Multiple Sclerosis 18. Studies with fewer patients involved: the Adaptive Trial 19. Studies with less site involvement: the Hyper Trial 20. Studies without sites: the Virtual Trial Section 5: From Data to Decisions 21. Data standards against data overload 22. Data management 2.0 23. What do Sites Want? 24. From data to information and decision: ICONIK 25. Knowledge Management 26. Taking Control of Ever Increasing Volumes of Unstructured Data 27. Share the Knowledge based on quality data Section 6: You Need Processes, Systems and People 28. It's all about the people (and their competencies) 29. Manage the Change 30. How Key Performance Indicators help to manage the change Conclusions
Copyright Date
2015
Topic
Clinical Medicine, Pharmacology
Intended Audience
Scholarly & Professional
Illustrated
Yes
Genre
Medical
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