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.Niccolò 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.

“Clinical Trials in Older Adults” is essential reading for anyone developing drugs or medical devices that could be useful treatments for the elderly." (Journal of Clinical Research Best Practices 2016)

• Contributors viiPreface xiPart I: The frame1 The exclusion of older subjects from clinical trials: the PREDICT study 3Antonio Cherubini & Peter Crome2 Clinical trials in older adults: a point of view from the industry 23Susanna Del Signore & Philippe Guillet3 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]DubucPart II: The implementation4 Mastering the design of clinical trials for older persons: the tension between external validity and feasibility 63Luigi Ferrucci & Stephanie Studenski5 Pharmacokinetic and pharmacodynamic studies in older adults 79Arduino A. Mangoni, Paul A.F. Jansen & Stephen H.D. Jackson6 The role of comprehensive geriatric assessment (CGA) of older adults in clinical studies 95Graziano Onder, Agnese Collamati, Andrea Poscia & Roberto Bernabei7 Statistical issues in designing and interpreting clinical trials in older adults 107Heather Allore, Mark A. Espeland & Michael E. MillerPart III: The examples8 Challenges in implementing large]scale clinical trials in moderately functioning older adults 127Stephen D. Anton, Sandrine Sourdet, Marco Pahor & Todd Manini9 Clinical trials in Alzheimer’s disease 153Julien Delrieu & Bruno Vellas10 Clinical trials in late]life mood disorders 173Lucio Ghio, Werner Natta, Marco Vaggi & Luigi Ferrannini11 Clinical trials for conditions of low muscle mass and strength 197Stephanie Studenski, Rosaly Correa-de-Araujo & Luigi Ferrucci12 Clinical trials of cancer treatment in the elderly 219Lodovico Balducci. Iordanis Gravanis & Francesco Pignatti13 Clinical trials in nursing homes: challenges and practical solutions 231Sandra Simmons, Barbara Resnick, John Schnelle & Joseph G. OuslanderIndex 255

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.Niccolò 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.

“Clinical Trials in Older Adults” is essential reading for anyone developing drugs or medical devices that could be useful treatments for the elderly." (Journal of Clinical Research Best Practices 2016)

• Contributors viiPreface xiPart I: The frame1 The exclusion of older subjects from clinical trials: the PREDICT study 3Antonio Cherubini & Peter Crome2 Clinical trials in older adults: a point of view from the industry 23Susanna Del Signore & Philippe Guillet3 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]DubucPart II: The implementation4 Mastering the design of clinical trials for older persons: the tension between external validity and feasibility 63Luigi Ferrucci & Stephanie Studenski5 Pharmacokinetic and pharmacodynamic studies in older adults 79Arduino A. Mangoni, Paul A.F. Jansen & Stephen H.D. Jackson6 The role of comprehensive geriatric assessment (CGA) of older adults in clinical studies 95Graziano Onder, Agnese Collamati, Andrea Poscia & Roberto Bernabei7 Statistical issues in designing and interpreting clinical trials in older adults 107Heather Allore, Mark A. Espeland & Michael E. MillerPart III: The examples8 Challenges in implementing large]scale clinical trials in moderately functioning older adults 127Stephen D. Anton, Sandrine Sourdet, Marco Pahor & Todd Manini9 Clinical trials in Alzheimer’s disease 153Julien Delrieu & Bruno Vellas10 Clinical trials in late]life mood disorders 173Lucio Ghio, Werner Natta, Marco Vaggi & Luigi Ferrannini11 Clinical trials for conditions of low muscle mass and strength 197Stephanie Studenski, Rosaly Correa-de-Araujo & Luigi Ferrucci12 Clinical trials of cancer treatment in the elderly 219Lodovico Balducci. Iordanis Gravanis & Francesco Pignatti13 Clinical trials in nursing homes: challenges and practical solutions 231Sandra Simmons, Barbara Resnick, John Schnelle & Joseph G. OuslanderIndex 255

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.Niccolò 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.

“Clinical Trials in Older Adults” is essential reading for anyone developing drugs or medical devices that could be useful treatments for the elderly." (Journal of Clinical Research Best Practices 2016)

• Contributors viiPreface xiPart I: The frame1 The exclusion of older subjects from clinical trials: the PREDICT study 3Antonio Cherubini & Peter Crome2 Clinical trials in older adults: a point of view from the industry 23Susanna Del Signore & Philippe Guillet3 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]DubucPart II: The implementation4 Mastering the design of clinical trials for older persons: the tension between external validity and feasibility 63Luigi Ferrucci & Stephanie Studenski5 Pharmacokinetic and pharmacodynamic studies in older adults 79Arduino A. Mangoni, Paul A.F. Jansen & Stephen H.D. Jackson6 The role of comprehensive geriatric assessment (CGA) of older adults in clinical studies 95Graziano Onder, Agnese Collamati, Andrea Poscia & Roberto Bernabei7 Statistical issues in designing and interpreting clinical trials in older adults 107Heather Allore, Mark A. Espeland & Michael E. MillerPart III: The examples8 Challenges in implementing large]scale clinical trials in moderately functioning older adults 127Stephen D. Anton, Sandrine Sourdet, Marco Pahor & Todd Manini9 Clinical trials in Alzheimer’s disease 153Julien Delrieu & Bruno Vellas10 Clinical trials in late]life mood disorders 173Lucio Ghio, Werner Natta, Marco Vaggi & Luigi Ferrannini11 Clinical trials for conditions of low muscle mass and strength 197Stephanie Studenski, Rosaly Correa-de-Araujo & Luigi Ferrucci12 Clinical trials of cancer treatment in the elderly 219Lodovico Balducci. Iordanis Gravanis & Francesco Pignatti13 Clinical trials in nursing homes: challenges and practical solutions 231Sandra Simmons, Barbara Resnick, John Schnelle & Joseph G. OuslanderIndex 255