Clinical Trials in Older Adults (Hardcover)

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 & Pauli¿½]Loup Weili¿½]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 largei¿½]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 latei¿½]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