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

by Peter Schueler (Editor), Brendan Buckley (Editor)

Overview

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 Details

ISBN-13:	9780128007907
Publisher:	Elsevier Science
Publication date:	12/16/2014
Sold by:	Barnes & Noble
Format:	eBook
Pages:	360
File size:	11 MB
Note:	This product may take a few minutes to download.

About the Author

Peter Schüler is Senior Vice President, Global Medical&Safety Services, ICON Plc. Peter is board certified in neurology (1996; German Medical Board) and in Pharmaceutical Medicine (2001; Swiss Medical Association). In 1999 in obtained a Certificate in Business Administration by Henley Management College, UK. After his medical education he started is professional career in 1987 at the Medical Imaging Application Center of Siemens AG Medical Solutions. The same year he started at the Department of Experimental Neuropsychiatry of the Neurological University Hospital Erlangen, Germany. During the coming 8 years he was involved in basic and clinical CNS research. He held the position of Secretary General of the German section of the International League Against Epilepsy (ILAE; 1991-1995) and was awarded two scientific awards (Alfred-Hauptman epilepsy prize and ILAE Young Investigator Award). In 1995 he joined Pharmacia. During that period, he participated in the launch of two NCEs in the indications Parkinson’s and major depression. In October 2000 he moved into the CRO business, building a department for Medical Affairs and also taking over responsibilities for clinical operations in Germany, Austria and Switzerland. In 2007, Peter joined ICON, now overseeing over 360 people located in 11 major offices in Argentina, Brazil, Germany, India, Japan, Latvia, Mexico, Poland, Singapore, UK and US. He issued several publications on drug safety and authored an eBook about clinical trial design and conduct (Zenosis Ltd publisher) and continues to lecture Pharmaceutical Medicine at the Universities of Duisburg-Essen, Germany and Aveiro, Portugal.
Brendan Buckley is Chief Medical Officer of ICON Plc. He was previously a co-founder of Firecrest Clinical. He is a Honorary Clinical Professor in the School of Medicine at University College Cork Ireland. A medical graduate of the National University of Ireland and a doctoral graduate in Biochemistry of Oxford University, he has over 30 years’ experience in clinical pharmacology research. Prior to joining ICON, he was Director of the European collaborative Centre for Clinical Trials in Rare Diseases at Cork. He was a member of the EMA Committee for Orphan Medicinal Products (COMP) from 2000-2003 and a member of the EMA Scientific Advisory Committee on Diabetes and Metabolism until 2011. He was a member of the Board of Directors of the Irish Medicines Board, the national competent authority for Ireland, 2004-2011 and chaired its statutory Advisory Committee for Human Medicines. He is chairman of the independent data and safety monitoring boards for a number of large clinical trials programmes with several sponsors. He is a member of the scientific advisory boards of a number of research charities and honorary Director of the Cork Cancer Research Centre. Professor Buckley is a Fellow of the Royal College of Physicians of Ireland, of the College’s Faculty of Pathology and a Fellow of the Faculty of Sports and Exercise Medicine.

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 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

What People are Saying About This

From the Publisher

The first book of its kind to offer best practices and solutions toward streamlining the drug development process to contain costs, integrate new technologies and increase efficiency

Editorial Reviews

Reviewer: Ryan Sol Funk, PharmD, MS, PhD (University of Kansas Medical Center)
Description: This book evaluates current methods used in the clinical phase of drug development and presents innovative approaches towards improving the process. It is designed to be an easy and quick to read resource for professionals involved in the clinical phase of drug development and highlights the role of technology in transforming the industry. It focuses on the reevaluation and redesign of the current clinical trial model with emphasis on improving the processes, systems, and people.
Purpose: The purpose is to educate professionals involved in the clinical development of drugs on potential solutions to systemic problems faced by the pharmaceutical industry. After successfully documenting the need for change in the industry, the book illustrates several innovative approaches to improve the development process.
Audience: It is targeted at professionals involved in the clinical phase of drug development. Although it provides mostly surface coverage on these topics, it is a good overview. The authors include industry representatives and academicians.
Features: The book starts with an overview of the current problems faced by the pharmaceutical industry and presents the need for innovation in the industry in order to survive in the modern economy. Focusing on the clinical development phase of drug development, the book addresses several areas where innovation is needed and presents novel strategies that may represent future industry standards. It maintains a consistent focus on how technology can be used as a major tool of innovation and promotes the need for improvement in three key areas: processes, systems, and people. Chapters use a similar format that presents "the need" and "the solution," along with a SWOT analysis and an overview referred to as the "take home message." The book could use some editing for grammatical errors, the quality of figures could be improved, and the addition of detailed figure legends would be helpful. In addition, there is some apparent commercial bias and repetition.
Assessment: Despite its faults, this book does present a good overview of problems facing the pharmaceutical industry in the design and conduct of clinical trials, especially within the current regulatory framework. In presenting these issues, it adequately describes various efforts to address these problems and presents examples where possible.

Doody's Review Service

"...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

From the Publisher