Synopses & Reviews
Now published in its Second Edition, the
Textbook of Clinical Trialsoffers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume.
Praise for the First Edition:
"... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005
The book’s main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues.
The Textbook of Clinical Trials, Second Edition:
- Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areas
- Describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields
- Additional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing area
- Newly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane network
An invaluable resource for pharmaceutical companies, the
Textbook of Clinical Trials, Second Editionappeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.
Review
“…very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas.” (British Journal of Surgery, Vol.92, No.2, February 2005)
"…a very interesting book…" (Applied Clinical Trials, July 2004)
Synopsis
The comprehensive volume on clinical trials covers all important disease and therapeutic areas together with methodologies, phase I/II/III studies and other issues. It is the first book to deal with all important diseases and is an essential reference for all involved with clinical trials.
Synopsis
A comprehensive volume on clinical trials that covers all important disease and therapeutic areas together with methodologies, phase I/II/III studies and other issues.
The volume catalogues the impact of clinical trials on the practice of medicine and discusses the developments and practice of medical statistics. Cancer, cardiovascular disease, dermatological, dental, mental, ophthalmic health, gynaecology and respiratory diseases are all discussed in separate chapters, with discussions on outcome measures, competing risks and statistical models given for each therapy area.
It also presents:
* A history of clinical trials
* A summary of pertinent statistical issues
* How to choose a clinical trial design
* Ethical constraints and considerations
* Clinical trial issues in paediatrics and those involving older patients
* Clinical trials in complementary medicine
Synopsis
* Clinical trials in complementary medicine
Synopsis
Textbook of Clinical Trials highlights the varied ways that clinical trials – particularly randomised controlled trials – have influenced the practice of medicine in many therapeutic areas. It describes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fields and blends the development of clinical trial statistical methodology into this process.
Uniquely this Textbook addresses issues as they impact on patients with diseases in the following specific areas:
- Cancer
- Cardiovascular disease
- Complementary medicine
- Respiratory disease
- Dermatology
- Dental disease and disorders
- Mental health
- Alzheimer’s Disease
- Reproductive health
- Gynaecology
In addition, chapters deal with special issues in children and older patients.
This is an essential reference for all involved with clinical trials. It will be of particular relevance to clinical trialists, whether with administrative, data management and quality, scientific or statistical roles, workers in the pharmaceutical industry, those who sit on ethics committees, work in regulatory departments or grant awarding bodies and doctors taking part in the conduct of clinical trials.
Draws together critical information in one key text
Synopsis
Textbook of Clinical Trials second edition continues the original aim, to highlight the varied ways that clinical trials - particularly randomized controlled trials - have influenced the practice of medicine within different therapeutic areas. It describes the different challenges posed by those conducting clinical trials across a range of medical specialities and allied fields and at the same incorporates the development of clinical trial statistical methodology. The background to each medical speciality is provided, followed by the characteristic problems experienced by trialists in that area. Case studies are used throughout to provide a comprehensive key text in this rapidly expanding area.
This unique way of presenting clinical trial information will make this second edition an essential reference for clinical trialists, whether with administrative, data management and quality, scientific, medical or statistical roles. In addition it will provide a reference for pharmaceutical industry personnel, members of ethics committees and those who work in regulatory departments.
Building on the success of the first edition many new therapeutic areas are included including:
General surgery, plastic surgery, aesthetic surgery palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal cancer thyroid cancer urological cancer
About the Author
David Machin, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore.
Simon Day, Medicines and Healthcare Products Regulatory Agency, London, UK.
Sylvan Green, Arizona Cancer Center, Tucson, Arizona, USA.
Table of Contents
Contributors.
Preface.
INTRODUCTION.
1. Brief History of Clinical Trials (S. Day and F. Ederer).
2. General Issues (D. Machin)
3. Clinical Trials in Pediatrics (J.P.E. Karlberg).
4. Clinical Trials Involving Older People (C. Jagger and A.J. Arthur).
5. Complementary Medicine (P.C.Leung).
CANCER.
6. Breast Cancer (D.A. Barry, T.L. Smith and A.U. Buzdar).
7. Childhood Cancer (S.B. Murphy and J.J. Shuster).
8. Gastrointestinal Cancers (D. Sargent, R. Goldberg and P. Limburg).
9. Haemotologic Cancers (C.A. Schiffer and S.L. George).
10. Melanoma (P.-Y. Liu and V.K. Sondak).
11. Respiratory Cancers (K. Kim).
CARDIOVASCULAR.
12. Cardiovascular (L. Friedman and E. Schron).
DENTISTRY AND MAXILLO-FACIAL.
13. Dentistry and Maxillo-facial(M Wong, C McGrath and E Lo).
DERMATOLOGY.
14. Dermatology (L. Naldi and C. Minelli).
PSYCHIATRY.
15. Overview (B.S. Everitt).
16. Alzheimer’s Disease (L.J. Thal and R.G. Thomas).
17. Anxiety Disorders (M.K Shear and P.W. Lavori).
18. Cognitive Behaviour (N. Tarrier and T. Wukes).
19. Depression (G. Dunn).
REPRODUCTIVE HEALTH.
20. Contraception (G. Piaggio).
21. Gynaecology and Infertility (S. Bhattacharya and J. Mollison).
RESPIRATORY.
22. Respiratory (A. Källén).
Index.