Textbook of Clinical Trials

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: "e;... very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas."e; 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.

Now published in its Second Edition, the Textbook of ClinicalTrials offers detailed coverage of trial methodology indiverse areas of medicine in a single comprehensive volume.Praise for the First Edition:"... very useful as an introduction to clinical research, orfor those planning specific studies within therapeutic or diseaseareas." BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2February 2005The book's main concept is to describe the impact ofclinical trials on the practice of medicine. It separates theinformation by therapeutic area because the impact of clinicaltrials, the problems encountered, and the numbers of trials inexistence vary tremendously from specialty to specialty. Thesections provide a background to the disease area and generalclinical trial methodology before concentrating on particularproblems experienced in that area. Specific examples are usedthroughout to address these issues.The Textbook of Clinical Trials, SecondEdition:* Highlights the various ways clinical trials have influenced thepractice of medicine in many therapeutic areas* Describes the challenges posed by those conducting clinicaltrials over a range of medical specialities and allied fields* Additional therapeutic areas are included in this SecondEdition to fill gaps in the First Edition as the numberand complexity of trials increases in this rapidly developingarea* Newly covered or updated in the Second Edition: generalsurgery, plastic surgery, aesthetic surgery, palliative careprimary care, anaesthesia and pain, transfusion, wound healingmaternal and perinatal health, early termination, organtransplants, ophthalmology, epilepsy, infectious diseaseneuro-oncology, adrenal, thyroid and urological cancers, as well asa chapter on the Cochrane networkAn invaluable resource for pharmaceutical companies, theTextbook of Clinical Trials, Second Edition appealsto those working in contract research organizations, medicaldepartments and in the area of public health and health sciencealike.

List of Contributors ixPreface to Second Edition xviiPreface the First Edition xixIntroduction 11 The Development of Clinical Trials 3Simon Day2 General Statistical Issues 13David Machin3 The Cochrane Collaboration 39Mike ClarkeCancer 474 Breast Cancer 49Donald A. Berry, Terry L. Smith and Aman U. Buzdar5 Childhood Cancer 63Sharon B Murphy and Jonathan J.Shuster6 Gastrointestinal Cancers 81Daniel Sargent, Richard Goldberg and Paul Limburg7 Melanoma 105Ping-Yu Liu and Vernon K. Sondak8 Respiratory Cancers 121Joan H. Schiller and Kyungmann Kim9 Adrenal Cortical Carcinoma 137Isha Malik and Petros Perros10 Thyroid Cancer 143Vijayaraman Arutchelvam and Petros Perros11 Urologic Cancers 149Edith D. Canby-Hagino, Catherine M. Tangen, and Ian M. Thompson12 Haematologic Cancers: Challenges in Developing New Therapeutic Approaches 167Charles A. Schiffer and Stephen L. GeorgeCardiology 17713 Acute Stroke 179Philip Bath14 Cardiovascular Disease 215Krishna PrasadDentistry and Oral Health Care 24115 Dentistry and Oral Health Care 243May C.M. Wong, Colman McGrath and Edward C.M. LoDermatology 26116 Dermatology 263Luigi Naldi and Cosetta MinelliInfectious Diseases 28717 HIV Infection 289Michael D. Hughes18 Infectious Diseases 303Ingela KrantzOphthalmology 31719 Ophthalmology 319Jonathan C.K. Clarke and Peng-Tee KhawPsychiatry 33320 Anxiety Disorders 335M. Katherine Shear and Philip W. Lavori21 Cognitive Behaviour Therapy 353Nicholas Tarrier and Til Wykes22 Psychotherapy for Depression 377Graham DunnReproductive Health 39523 Contraception 397Gilda Piaggio and Timothy M.M. Farley24 Gynaecology and Infertility 421Siladitya Bhattacharya and Jill Mollison25 Early Pregnancy Termination 443Beverly Winikoff and Batya Elul26 Maternal and Perinatal Health 459José Villar, Allan Donner, Edgardo Abalos and Liana CampódonicoRespiratory 47527 Respiratory Medicine 477Anders KällénSurgery & Anaesthesia 51728 Anaesthesia and Pain 519Paul S. Myles and John Rigg29 General Surgery 543Dr Olga Jonasson and Domenic Reda30 Plastic Surgery - Reconstructive Surgery 553Erik Ang and Woffles Wu31 Plastic Surgery - Aesthetic Surgery 575Woffles Wu and Erik AngTransplantation 59132 Renal Transplantation 593Vathsala AnantharamanOther Procedures 60533 Wound Healing 607Colin Song and Edwin Chan34 Palliative Care 627Robert S. Krouse and David Casarett35 Complementary Medicine 647Ping-Chung Leung36 Cluster Randomized Trials in Health Care Research 669Randall D. Cebul, Neal V. Dawson and Thomas E. Love37 Nursing 681Nicola CrichtonSpecial Populations 69938 Clinical Trials in Paediatrics 701Johan P.E. Karlberg39 Clinical Trials Involving Older People 711Carol Jagger and Antony J. Arthur40 Clinical Trials in Rare Diseases 723Simon DayIndex 735