Clinical Trials in Older Adults

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