The first book of its kind to offer best practices and solutions toward streamlining

the drug development process in order to contain costs, integrate new technologies

and increase efficiency

KEY FEATURES

• 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

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.

Re-Engineering Clinical Trials Best Practices for Streamlining Drug Development

Edited by: Peter Schueler MD, Senior VP Medical and Safety Services,

ICON Clinical Research, Frankfurt, Germany

Brendan Buckley Professor, MD DPhil FRCPI, Chief Medical Officer

ICON plc, Dublin, Ireland

Print ISBN: 978-0-12-420246-7

eBook ISBN: 978-0-12-

800790-7

PUB DATE: Jan 2015

LIST PRICE: $99.95

FORMAT: Hardback

PAGES: c. 300

TRIM: 6w x 9h

AUDIENCE: For all those

involved in the process of

clinical development and

clinical trial design, from

beginners to project managers

to decision makers in the

pharmaceutical industry and

CROs and vendors such as

BPO, SMO, etc.

LIFE SCIENCES

Please visit Store.Elsevier.com to learn more

TABLE OF CONTENTS

Section 1: Why Does the Industry Need a Change?

1. Why is our industry struggling? Kenneth Getz and Kenneth I. Kaitin

2. What are the current main obstacles to reach drug approval? Pol Boudes

3. Japan: An opportunity to learn? Yuji Sato

4. The "Clinical Trial App" Urs-Vito Albrecht and Oliver Pramann

Section 2: What Does Our Industry and What Do Others Do

5. What does "re-engineering" mean in our industry? Wolfgang Renz and Stan Kachnowski

6. How can the Innovative Medicines Initiative help to make drug development more efficient? Matthias

Gottwald

7. Experiences with Lean and Shopfloor Management in R&D in other branches Andreas Hans Romberg

8. Well-known methodologies, but not in our world: FMEA Winfried Dietz

Section 3: Where to Start: The Protocol

9. No patients, no data: Patient recruitment in the 21st century Chris Trizna

10. The impact of bad protocols Kenneth Getz and Kenneth I. Kaitin

11. Data mining for better protocols Michelle Marlborough

12. It is all in the literature Johannes Bernhard Lampe

13. What makes a good protocol better? Peter Schueler

14. The Clinical Trial Site Brendan Buckley

Section 4: Alternative Study Designs

15. Do we need new endpoints? Surrogate and bio-marker Erich Mohr

16. On the measurement of the disease status in clinical trials: lessons from MS Martin Daumer

17. Generating evidence from historical data using “robust prognostic matching”: Experience from Multiple

Sclerosis Martin Daumer

18. Studies with fewer patients involved: the Adaptive Trial Simon Day

19. Connected Health in Clinical Trials: The Patient as Sub-Investigator Brendan Buckley

20. Studies without sites: the Virtual Trial Miguel Orri

Section 5: From Data to Decisions

21. Data standards against data overload Wayne Kubick

22. Data management 2.0 Johann Proeve

23. What do Sites Want? Andrew Mitchell, Jochen Tannemann and Kevin McNulty

24. From data to information and decision: ICONIK Malcolm Neil Burgess, Nicholas John Alp and Gareth

Milborrow

25. Knowledge Management Nick Milton

26. Taking Control of Ever Increasing Volumes of Unstructured Data Henrik Nakskov

27. Share the Knowledge based on quality data Liselotte Hyveled

Section 6: You Need Processes, Systems and People

28. It's all about the people (and their competencies) Mike Hardman and Martin Robinson

29. Manage the Change Heather Fraser

30. How Key Performance Indicators help to manage the change Linda B. Sullivan

Conclusions Brendan Buckley and Peter Schueler