Textbook of Clinical Trials

ISBN-13: 9780470010143 / Angielski / Twarda / 2007 / 784 str.

David Machin; David Machin; Simon Day

Opis

Now published in its Second Edition, the Textbook of Clinical Trials offers 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 Edition appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

Spis treści

List of Contributors.

Preface to Second Edition.

Preface the First Edition.

INTRODUCTION.

1 The Development of Clinical Trials (Simon Day).

2 General Statistical Issues (David Machin).

3 The Cochrane Collaboration (Mike Clarke).

CANCER.

4 Breast Cancer (Donald A. Berry, Terry L. Smith and Aman U. Buzdar).

5 Childhood Cancer (Sharon B Murphy and Jonathan J.Shuster).

6 Gastrointestinal Cancers (Daniel Sargent, Richard Goldberg and Paul Limburg).

7 Melanoma (Ping–Yu Liu and Vernon K. Sondak).

8 Respiratory Cancers (Joan H. Schiller and Kyungmann Kim).

9 Adrenal Cortical Carcinoma (Isha Malik and Petros Perros).

10 Thyroid Cancer (Vijayaraman Arutchelvam and Petros Perros).

11 Urologic Cancers (Edith D. Canby–Hagino, Catherine M. Tangen, and Ian M. Thompson).

12 Haematologic Cancers: Challenges in Developing New Therapeutic Approaches (Charles A. Schiffer and Stephen L. George).

CARDIOLOGY.

13 Acute Stroke (Philip Bath).

14 Cardiovascular Disease (Krishna Prasad).

DENTISTRY AND ORAL HEALTH CARE.

15 Dentistry and Oral Health Care (May C.M. Wong, Colman McGrath and Edward C.M. Lo).

DERMATOLOGY.

16 Dermatology (Luigi Naldi and Cosetta Minelli).

INFECTIOUS DISEASES.

17 HIV Infection (Michael D. Hughes).

18 Infectious Diseases (Ingela Krantz).

OPHTHALMOLOGY.

19 Ophthalmology (Jonathan C.K. Clarke and Peng–Tee Khaw).

PSYCHIATRY.

20 Anxiety Disorders (M. Katherine Shear and Philip W. Lavori).

21 Cognitive Behaviour Therapy (Nicholas Tarrier and Til Wykes).

22 Psychotherapy for Depression (Graham Dunn).

REPRODUCTIVE HEALTH.

23 Contraception (Gilda Piaggio and Timothy M.M. Farley).

24 Gynaecology and Infertility (Siladitya Bhattacharya and Jill Mollison).

25 Early Pregnancy Termination (Beverly Winikoff and Batya Elul).

26 Maternal and Perinatal Health (Jos´e Villar, Allan Donner, Edgardo Abalos and Liana Camp´odonico).

RESPIRATORY.

27 Respiratory Medicine (Anders Källén).

SURGERY & ANAESTHESIA.

28 Anaesthesia and Pain (Paul S. Myles and John Rigg).

29 General Surgery (Dr Olga Jonasson and Domenic Reda).

30 Plastic Surgery Reconstructive Surgery (Erik Ang and Woffles Wu).

31 Plastic Surgery Aesthetic Surgery (Woffles Wu and Erik Ang).

TRANSPLANTATION.

32 Renal Transplantation (Vathsala Anantharaman).

OTHER PROCEDURES.

33 Wound Healing (Colin Song and Edwin Chan).

34 Palliative Care (Robert S. Krouse and David Casarett).

35 Complementary Medicine (Ping–Chung Leung).

36 Cluster Randomized Trials in Health Care Research (Randall D. Cebul, Neal V. Dawson and Thomas E. Love).

37 Nursing (Nicola Crichton).

SPECIAL POPULATIONS.

38 Clinical Trials in Paediatrics (Johan P.E. Karlberg).

39 Clinical Trials Involving Older People (Carol Jagger and Antony J. Arthur).

40 Clinical Trials in Rare Diseases (Simon Day).

Index.

O autorze

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.

Blurb

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