Re-Engineering Clinical Trials
Best Practices for Streamlining the Development Process
- 2nd Edition - March 2, 2029
- Latest edition
- Editors: Peter Schueler, Brendan Buckley
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 2 0 4 8 9 - 4
- eBook ISBN:9 7 8 - 0 - 3 2 3 - 9 8 4 2 4 - 9
Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process, Second Edition evaluates the trends and challenges associated with the current drug develo… Read more
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Re-Engineering Clinical Trials: Best Practices for Streamlining the Development Process, Second Edition evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern technologies and novel study designs. 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. More focus on rare diseases and personalized medicines increase the need for more efficient processes. This book focuses on the need to simplify drug development and offers well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. The second edition is completely updated, including new sections on Patient Centricity, Machine Learning, Bayesian Statistics, Disruption in R&D, Wearable technologies, Virtual trials, Real World Evidence, Operational Analytics. 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, resources for further reading and useful solutions to day-to-day problems in current drug development
- Includes new sections on important topics such as patient centricity, machine learning, Bayesian statistics, disruption in R&D, wearable technologies, virtual trials, real world evidence, operational analytics as well as completely updated chapters
Pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design
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
- Edition: 2
- Latest edition
- Published: March 2, 2029
- Language: English
PS
Peter Schueler
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.
Affiliations and expertise
MD, Senior VP Medical and Safety Services, ICON Clinical Research, Frankfurt, Germany and Auxiliary Professor for Pharmaceutical Medicine, Universities Duisburg-Essen, Germany and Aveiro, PortugalBB
Brendan Buckley
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.
Affiliations and expertise
MD DPhil FRCPI, Chief Medical Officer ICON plc, Dublin, Ireland and Honorary Clinical Professor, School of Medicine, University College Cork, Ireland