Synopsis
Clinical trials are at the heart of the successful development of new medicines for patients. Like any other specialized area, clinical trials has a vocabulary and jargon all its own and the processes involved are highly standardized for ethical, practical and regulatory reasons. No matter. Most people can get a grip on the topic in sufficient detail to understand in general terms what people are talking about.
The first part of this book provides a helicopter view of the clinical trials process with Chapter 1 explaining why we do what we do as a broad structure into which the later process chapters will fit. The second chapter reviews the history of clinical trials per se and the evolving ethical and regulatory considerations (i.e., how we got to where we are). Complementing these two chapters is the commercial perspective: the imperative for moving forward. Armed with these three chapters as background, the succeeding nuts and bolts process chapters will fall into place. You will be able to see exactly how any given discipline fits in and plays its part in delivering the overall clinical trial program. For make no mistake, the successful design, execution and delivery of an effective clinical trial program relies on excellent cooperation, understanding and respect within an often widely dispersed multi-disciplinary team. We specifically set out to ask experienced clinical researchers from all the relevant disciplines to write succinct and straightforward chapters which would explain what their role is and how this fits into a very exciting big picture, overall.
In addition, we felt it was very important to acknowledge the role of the patient because without their participation no clinical trial would proceed. Frequently, it is the enthusiasm and dedication of patients that keep clinical trials on track. There is currently a great need for a better public support of clinical trials, but this can only happen if both patients and clinical trial researchers fully engage with each other. Many clinical researchers are highly experienced in the operational and regulatory aspects of trials, but how many of them have actually become involved as a patient? The answer is probably very few! In combination with the other contributions, Chapter 13 helps fill this gap as it is written by someone who has both worked on clinical trials and yet also participated as a patient.
We have tried to present these chapters in a logical way so that the flow of the clinical trials process is also apparent. This is rather artificial, as it will be clear to those who read the book straight through, that many activities happen in parallel and that while there is relatively little down time for any specific group, there are often times of frenzied activity! Each chapter also stands alone as a quick dip foundation or refresher. Everyone involved in clinical trials finds it demanding to keep up-todate with current developments in the field. Therefore, as a final aspect to the book we have tried to explore what the future of clinical trials might be. There are numerous factors that have shaped clinical trials until now and far more that will influence their development in the future. We can only guess at what the future of clinical trials might be, but one certainty is that we will continue to rely on them for the development of new medicines.
We believe you will come away with a really good basic grasp of the excitement of the clinical trials process, its drivers, checks and balances, and how you may even be able to contribute in a wide variety of ways.
About the Author
Dr. Bill Byrom joined the Pharmaceutical industry in 1991 after completing a Ph.D. at Strathclyde University, and has worked in Statistics, Clinical Development and International Marketing.
Dr. Madhu Davies qualified in medicine in the United Kingdom in 1987. Following six years in the clinic in general practice, she worked as a consultant in pharmaceutical medicine, she is also editor of Pharmaceutical Physician.
Dr. Ignazio di Giovanna holds a BSc in Physiology and Ph.D. in Biophysics from the University of London and joined the Pharmaceutical industry in 1986, since which he s worked both within the pharma and CRO settings.
Ms. Sue Green has worked in global regulatory affairs for >17 years. She established Shore Ltd to provide regulatory support and strategic advice for drug development.
Dr. Felix Khin-Maung-Gyi founded Chesapeake Research Review in 1993. He currently Co-Chairs a subcommittee designated to review regulations on human research. Dr. Gyi received PharmD from Duquesne Univ.
Dr. Gareth Hayes has over 27 years industry experience and continues in training; he regularly contributes articles to the journal CRfocus.
Dr. Todd Johnson is SVP, Strategy & Corp Dev. at MDS Pharma Services, contract research organization. Todd was Founder and CEO of Tangerine Technologies (drug discovery software); MBA Wharton, MD from Penn s Medical School.
Dr. Suzanne Junod received her M.A. & Ph.D. from Emory Univ. in the history of medicine. She served as FDA liaison & historical consultant for President Clinton s Advisory Committee on Human Radiation. BR>
Dr. Faiz Kermani has experience in academia & industry. He has worked in R&D, pricing, reimbursement, marketing, medical communications; Ph.D. in Immunopharmacology from St. Thomas Hospital London.
Ms. Liz Langley, Surrey Univ, BSc in Biochemistry (Medical), has worked with British Association of Pharmaceutical Physicians since '92 and is involved with training, & ed. of physicians.
Dr. Jim McClurg received his Ph.D. in biochemistry, Univ Nebraska. Jim serves as Sr VP & Chief Scientific Officer at MDS Pharma Services.
Ms. Lisa Nash, BSc (Hons) Chemistry, Univ. College London, Post Graduate in Education in Science Homerton Coll, Cambridge; has worked as a Clinical Data Coordinator before joining GlaxoSmithKline. Currently, she is a Therapeutic Programme Manager.
Ms. Cathy O Brien is a chartered statistician with over 20 years experience in pharmaceuticals; London University, degree in Biology and Mathematics; MSc in Medical Statistics from Leicester University.
Ms. Jan Robinson; BSc in Biological Sciences, qualified nurse, 11 years nursing specializing in intensive care. Joined PharmaKodex Ltd, as Dir. Clinical Operations. Founder member and chair of the Institute of Clinical Research.
Mr. David B. Stein, VP Product Management at Cliniphone; 20 years Pharmaceutical technologies experience. Established Data Management departments, founded a start-up company providing mobile patient-reported software.
Ms. Fiona Swain has 15 years experience as a medical writer; BSc (Hons) in Pharmacology Glasgow University; accreditation from the Amer Medical Writers Association, member European Medical Writers Assn. Main areas of expertise: reporting clinical trials, writing summary documents for new drug license applications.
Dr. Graham Wylie, CEO, Medical Research Network Ltd.; 17 years in clinical trials, project management, global implementation of standard trial processes and IT. Parexel's Medical Dir N. Europe. Joined Healthcare at Home to develop clinical trials business.
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