Clinical Trials in Older Adults

Clinical Trials in Older Adults is the first book to consider the methodological issues underlying the evaluation of new treatments in older people. Provides information on the methodology, monitoring and regulations for those planning to conduct a clinical trials involving older adults Contains examples of ongoing trials involving older adults, and presents the main characteristics of many recently published Depicts how the issues regarding older adults in clinical trials could be properly addressed with the appropriate study design and conduct Identifies key issues in performing clinical trials in older patients with common geriatric conditions, i.e. Alzheimer s dementia, depression, low muscle mass, cancer INDICE: Contributors vii .Preface xi .Part I: The frame .1 The exclusion of older subjects from clinical trials: the PREDICT study 3Antonio Cherubini & Peter Crome .2 Clinical trials in older adults: a point of view from the industry 23Susanna Del Signore & Philippe Guillet .3 Ethical issues in clinical trials involving older subjects: the right to participate in clinical trials and have access to care; the protection of vulnerable subjects and the issue of informed consent 45Emmanuel Hirsch & Paul ]Loup Weil ]Dubuc .Part II: The implementation .4 Mastering the design of clinical trials for older persons: the tension between external validity and feasibility 63Luigi Ferrucci & Stephanie Studenski .5 Pharmacokinetic and pharmacodynamic studies in older adults 79Arduino A. Mangoni, Paul A.F. Jansen & Stephen H.D. Jackson .6 The role of comprehensive geriatric assessment (CGA) of older adults in clinical studies 95Graziano Onder, Agnese Collamati, Andrea Poscia & Roberto Bernabei .7 Statistical issues in designing and interpreting clinical trials in older adults 107Heather Allore, Mark A. Espeland & Michael E. Miller .Part III: The examples .8 Challenges in implementing large ]scale clinical trials in moderately functioning older adults 127Stephen D. Anton, Sandrine Sourdet, Marco Pahor & Todd Manini .9 Clinical trials in Alzheimer s disease 153Julien Delrieu & Bruno Vellas .10 Clinical trials in late ]life mood disorders 173Lucio Ghio, Werner Natta, Marco Vaggi & Luigi Ferrannini .11 Clinical trials for conditions of low muscle mass and strength 197Stephanie Studenski, Rosaly Correa–de–Araujo & Luigi Ferrucci .12 Clinical trials of cancer treatment in the elderly 219Lodovico Balducci. Iordanis Gravanis & Francesco Pignatti .13 Clinical trials in nursing homes: challenges and practical solutions 231Sandra Simmons, Barbara Resnick, John Schnelle & Joseph G. Ouslander .Index 255

• ISBN: 978-1-118-32349-6
• Editorial: Wiley–Blackwell
• Encuadernacion: Cartoné
• Páginas: 280
• Fecha Publicación: 11/09/2015
• Nº Volúmenes: 1
• Idioma: Inglés