Clinical Trials in Older Adults

Antonio Cherubini, is Director of Geriatrics and Geriatric Emergency Care at IRCCS-INRCA, Ancona, Italy. He is Associate Professor of Gerontology and Geriatrics at the Perugia University Medical School. He was research fellow at the department of Neurology, Massachusetts General Hospital, Harvard Medical School, from 1997-1998. He is co-author of several books of geriatric medicine in Italy. He is author of more than 200 papers in peer reviewed international journals. He is currently member of the Geriatric Expert Group of the European Medicine Agency. Roberto Bernabei, Department of Gerontology and Geriatrics, Catholic University of Sacred Heart, Rome, Italy. Luigi Ferrucci is the Scientific Director of the National Institute of Aging, NIH, Baltimore, MD, USA. Niccolo Marchionni, Department of Critical Care Medicine and Surgery, Unit of Gerontology and Geriatric Medicine, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. Bruno Vellas, Gerontopole de Toulouse. Department of Geriatric Medicine, Toulouse University Hospital, Toulouse; INSERM Unit 1027. University Toulouse III. Toulouse, France. Stephanie Studenski, Professor of Medicine and Director of Research, Division of Geriatric Medicine, Program Director, Pittsburgh Pepper Center; Director, AOC in Geriatric Medicine, Staff Physician at the GRECC, VA Pittsburgh Healthcare System.

Contributors vii Preface xi Part I: The frame 1 The exclusion of older subjects from clinical trials: the PREDICT study 3 Antonio Cherubini & Peter Crome 2 Clinical trials in older adults: a point of view from the industry 23 Susanna 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 45 Emmanuel 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 63 Luigi Ferrucci & Stephanie Studenski 5 Pharmacokinetic and pharmacodynamic studies in older adults 79 Arduino A. Mangoni, Paul A.F. Jansen & Stephen H.D. Jackson 6 The role of comprehensive geriatric assessment (CGA) of older adults in clinical studies 95 Graziano Onder, Agnese Collamati, Andrea Poscia & Roberto Bernabei 7 Statistical issues in designing and interpreting clinical trials in older adults 107 Heather Allore, Mark A. Espeland & Michael E. Miller Part III: The examples 8 Challenges in implementing large?]scale clinical trials in moderately functioning older adults 127 Stephen D. Anton, Sandrine Sourdet, Marco Pahor & Todd Manini 9 Clinical trials in Alzheimer s disease 153 Julien Delrieu & Bruno Vellas 10 Clinical trials in late?]life mood disorders 173 Lucio Ghio, Werner Natta, Marco Vaggi & Luigi Ferrannini 11 Clinical trials for conditions of low muscle mass and strength 197 Stephanie Studenski, Rosaly Correa-de-Araujo & Luigi Ferrucci 12 Clinical trials of cancer treatment in the elderly 219 Lodovico Balducci. Iordanis Gravanis & Francesco Pignatti 13 Clinical trials in nursing homes: challenges and practical solutions 231 Sandra Simmons, Barbara Resnick, John Schnelle & Joseph G. Ouslander Index 255