Quick Guide to Clinical Trials: For people who may not know it all (HC, 2nd Ed) - Hardcover

Dr. Madhu Davies; And Dr. Faiz Kermani; Dr. Faiz Kermani

Hardcover

ISBN 10: 1934106305 ISBN 13: 9781934106303

Publisher: BioPlan Associates, Inc., 2016

Synopsis

NOTE: ACADEMIC DISCOUNTS AVAILABLE: bioplanassociates.com/qg-clinical-trials/
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 this title

About the Author

Dr. Bill Byrom As Senior Director within Product Innovation at ICON plc, focusing on harnessing new technologies within clinical trials, Dr Byrom worked within the pharmaceutical industry for over 25 years. He is an industry thought leader in the area of eClinical technologies and is the author of over 60 publications including a leading industry textbook on electronic Patient Reported Outcomes (ePRO). Dr Byrom is Industry Vice Director of the Critical Path Institute s ePRO Consortium and the eClinical Forum, and holds a PhD in disease simulation.

Dr Lisa Chamberlain James, Senior Partner and CEO, Trilogy Writing & Consulting GmbH. Aside from management activities, Dr Chamberlain James also contributes to client projects, with extensive experience in a variety of documents, and with a special interest in drug safety and patient information. After receiving her PhD in Pathology, Dr. Chamberlain James began her medical writing career in Cambridge in 2000. Since then she has also been involved in the European Medical Writers Association (EMWA). Lisa is a member of the EMWA Educational Committee, a leader and assessor of EMWA workshops, a mentor of EMWA workshop leaders, has helped to produce the EMWA conference program from 2010 onwards, and holds an EMWA personal development certificate. A Fellow of the Royal Society of Medicine.

Dr Harris W. Dalrymple, PhD (Med), PhD, (Law), Executive Director, Scientific Affairs, PRAHS. After his academic career, Dr. Dalrymple spent nearly 25 years with a major pharmaceutical company followed by over a decade with two major contract research organizations, holding a variety of senior operational and managerial positions. His particular interest is in the involvement of vulnerable populations in research.

Dr Madhu Davies MB, ChB, MRCGP, FFPM, MBA. Dr Madhu has over 20 years experience with a range of pharmaceutical and biotechnology companies. She has supported the development and launch of a wide range of products in all the major markets and has been involved in the in-licensing and out-licensing of projects both in the large pharma and biotech setting. She is also a Non-Executive Director of a public sector organization, provides direction to the Postgraduate Course in Pharmaceutical Medicine (Cardiff University/British Association of Pharmaceutical Physicians) and is editor of Pharmaceutical Physician journal. She also co-edited the book Patient Compliance: Sweetening the Pill with Dr Faiz Kermani. Dr Madhu qualified in medicine from Birmingham University, she is a member of the Royal College of General Practitioners, a Fellow of the Faculty of Pharmaceutical Medicine and has an MBA from the Judge Business School, University of Cambridge.

Review

Joy Dummer, RGN (Hons), R.M., Senior Director of Project Delivery, PRA Health Sciences. Ms. Dummer has 30 years industry experience gained with several leading CROs. In previous roles she has been a Global Project Director, managing studies of all study phases across EU, North America and Asia Pacific. Therapeutic experience includes Oncology, CNS, Immunology, Infectious Disease, Women s Health and General medicine in adult and pediatric indications. Joy is also a Registered Nurse and State Registered Midwife. More recently she has held leadership positions in the CRO environment as Senior Director of Clinical Development, responsible for the project management team within a dedicated therapeutic Business unit.

Dr Julia Forjanic Klapproth, PhD. After receiving her PhD in Developmental Neurobiology, Dr Forjanic Klapproth started her career as a medical writer in 1997. In 2002, Julia co-founded Trilogy Writing & Consulting, a company specialized in providing medical writing of clinical regulatory documentation. For almost 20 years she has contributed her expertise in writing and coordinating all manner of regulatory documents. She has been President of the European Medical Writers Association (EMWA) twice and is an experienced trainer of medical writers, regularly running workshops for EMWA and pharmaceutical companies around the world.

Dr Ignazio Di Giovanna, PhD. Upon obtaining a PhD in Biophysics at Guys Hospital, based on development of non-invasive cardiovascular diagnosis techniques, Dr Di Giovanna joined the Pharmaceutical Industry in 1986 and has worked in the CRO field since 1990. Dr Ignazio Di Giovanna is owner and CEO of CCA Clinical Research, which has been established for over 25 years, a CRO which specializes in the management of phase I and II clinical studies. Dr Di Giovanna has been Chairman of the UK s Institute of Clinical Research (ICR) and also President of the Clinical Contract Research Association (CCRA). As a member of the Biotechnology & Pharmaceuticals Sector Advisory Group (BPSAG) he was active in advising the governmental body UKTI on trade and investment matters, with a view to increasing both for the UK economy. Dr Di Giovanna has also worked on a number of other industry related initiatives with the ABPI, NHS, R&D Forums and UKCRN; such as development of the mCTA, the national Costings Template and the Phase I insurance guidance. Dr Di Giovanna co-edited the Principles in Clinical Research , published in 2001 and in April 2004 was awarded an Honorary Fellowship by the ICR.

Dr Gareth Hayes, PhD. Dr Hayes is a dynamic trainer and has been a prevalent figure in the clinical research industry for over three decades, with over half of that in various monitoring and study management roles. Dr Hayes now runs Gareth Hayes Associates covering specialist training needs in addition to mandatory Good Clinical Practices. Professional mentoring is at the heart of Dr Hayes s purposeful curricula and includes career development programmes for all roles involved in research. Dr Hayes has latterly joined the Editorial Steering Committee of the new online Journal of Clinical Research & GCP. As well as delivering his own material Dr Hayes has also trained on behalf of Pharmaschool Ltd and the Institute of Clinical Research and in 2014 passed the Verified Assessor & Accreditation Programmes with the International Academy of Clinical Research. --Reviewer direct

Dr Todd Johnson, MD, MBA, CEO, CytoVas. Dr Johnson is a thought leader in precision medicine and drug development. He is currently CEO of CytoVas, a diagnostics company that is using proprietary data mining tools to discover new biomarkers for disease progression and treatment response. Prior to CytoVas, Dr Johnson s experiences range from consulting at McKinsey & Company, to leading the turnaround of Abbott Lab s pharma pipeline, enabling the creation of AbbVie. Dr Johnson holds a Bachelor of Arts from Penn, an MBA from its Wharton School, and an MD from Penn Med.

Dr Suzanne W. Junod. Dr Junod received her M.A. and PhD. from Emory University in the history of medicine. She came to the FDA as a historian in 1984. In 1994-5, she served as FDA liaison and historical consultant for President Clinton s Advisory Committee on Human Radiation Experiments (ACHRE). Dr Junod is on the Editorial Board of the Journal of the History of Medicine and Allied Sciences and has written the History Corner -- a bimonthly column for the Food and Drug Law Institute s Update publication for the past decade. Her publications are wide-ranging in the history of medicine and public health, including women s health, history of food additive regulation, as well as food and drug legal, scientific, and regulatory issues. She has received several professional awards for her writing.

Dr Faiz Kermani. Dr Kermani s background is in medical research and the pharmaceutical sector, where he has held scientific, regulatory and commercial roles in Europe and the US. He has practical experience of launching and publicizing the work of non-profit organizations, especially in the field of healthcare and education. He has also published a number of articles on neglected diseases and disparities in global healthcare. He serves on the board of the World Medical Fund (WMF), a medical charity working in Africa. WMF s main programs are in central Malawi and are treating more than 25,000 sick children every year. Dr Kermani has a PhD in Immunopharmacology from St. Thomas Hospital, London and a First Class Honors degree in Pharmacology with Toxicology from King s College, London.

Mrs. Elizabeth Langley. Mrs. Langley graduated from Surrey University in 1978 with a BSc (Hons) in Biochemistry (Medical) training to be a Clinical Chemist. Rather than pursue a hospital based role she joined the pharmaceutical industry working in a variety of roles including that of CRA, a New Product Development scientist, a regional sales team leader and marketing director. Since 2000 she has not only run her own company (LHA) but has also provided management services to the British Association of Pharmaceutical Physicians (BrAPP) which celebrates its 60th year in 2017. In 2014, fulfilling a long-term career ambition, BrAPP took over the future development, coordination and running of the internationally respected PostGraduate Course in Pharmaceutical Medicine and working with Cardiff University and Dr Madhu Davies, she has seen improved satisfaction from delegates and a sniff of improving academic results.

Dr Julie Meeson, PhD, J3i Limited. Dr Meeson is a Quality Assurance professional experienced is setting up Quality Management Systems for commercial organizations (Pharmaceutical, Biotechnology and Contract Research Organizations) as well as for research sites. She also assists organizations prepare for FDA and European regulatory inspections. --Reviewer direct

Dr Hajimu (Jim) Morioka serves as a consultant for a variety of businesses relating to biotechnology with TechNova Consulting Japan. He is also Team Leader, ABS Task Force Team for Academia under the instruction of the Ministry of Education, Culture, Sports, Science and Technology (MEXT). The ABS was set up to promote academic research using genetic resources at universities and institutions, enabling compliance with the Nagoya Protocol, a supplementary agreement to the Convention on Biological Diversity. The Nagoya Protocol covers areas such as access to genetic resources, benefit-sharing and compliance. Prior to this role Dr Morioka worked for 37 years in industry positions, conducting pharmaceutical R&D and licensing activities, strategic R&D planning and managing intellectual property on behalf of companies. Dr Morioka also served as a director of Japan biological Informatics Consortium for medicinal development. Dr Morioka graduated in microbiology and molecular biology from Kyoto University in 1975 and earned a PhD from the same university in 1988.

Lisa Nash BSc PGCE, GSK.
Mrs. Cathy O Brien, MSc. Mrs. O Brien is a chartered statistician with over 25 years in the pharmaceutical industry. She graduated from London University in 1985 with a degree in Biology and Mathematics and started work as a statistician in horticultural research before moving into clinical trials. She obtained an MSc in Medical Statistics from Leicester University. Having worked for both a CRO and a pharmaceutical company, she is currently working as a statistical consultant through her own business.

Dr Graham Wylie, Bsc MB BS, CEO, Medical Research Network. Dr Wylie is the CEO of the Medical Research Network, a business running clinical trial activities in the patient s own home, for 10 years. Dr Wylie s career started with 10 years at Pfizer, initially in Project Management and subsequently in systems and process re-engineering. After 5 years at Parexel as Medical Director for Northern Europe then VP Sales for Clinical Research Services, he joined Healthcare at Home in 2005, leading the management buyout of MRN in 2006. --Reviewer direct

Edition details

• Publisher: BioPlan Associates, Inc.
• Publication date: 2016
• ISBN 10: 1934106305
• ISBN 13: 9781934106303
• Binding: Hardcover
• Language: English
• Edition number: 2
• Number of pages: 317
• Editor: Dr. Madhu Davies, Dr. Faiz Kermani
• Illustrator: ES Design