Re-Engineering Clinical Trials : Best Practices for Streamlining the Development Process

著者名：Schueler, Peter (EDT)/Buckley, Brendan (EDT)

Academic Press（2014/12/16発売）

• 言語：ENG
• ISBN：9780124202467
• eISBN：9780128007907

Description

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

Table of Contents

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 Do5. 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 branches8. Well-known methodologies, but not in our world: FMEASection 3: Where to Start: The Protocol9. No patients, no data: Patient recruitment in the 21st century10. The impact of bad protocols11. Data mining for better protocols12. It is all in the literature13. What makes a good protocol better?14. The Clinical Trial SiteSection 4: Alternative Study Designs15. Do we need new endpoints? Surrogate and bio-marker16. On the measurement of the disease status in clinical trials: lessons from MS17. Generating evidence from historical data using "robust prognostic matching: Experience from Multiple Sclerosis18. Studies with fewer patients involved: the Adaptive Trial19. Studies with less site involvement: the Hyper Trial20. Studies without sites: the Virtual TrialSection 5: From Data to Decisions21. Data standards against data overload22. Data management 2.023. What do Sites Want?24. From data to information and decision: ICONIK25. Knowledge Management26. Taking Control of Ever Increasing Volumes of Unstructured Data27. Share the Knowledge based on quality dataSection 6: You Need Processes, Systems and People28. It's all about the people (and their competencies)29. Manage the Change30. How Key Performance Indicators help to manage the changeConclusions