Beschreibung
This book serves as a road map for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts. The examples focus on health-related quality of life and hyperhidrosis, in the context of clinical development of new medicines. Health-related quality of life represents one of the most commonly measured PROs in both routine clinical practice and research. The book demonstrates the importance of such outcomes to patients with chronic disease and how they can assist clinicians in managing patients and monitoring their response to treatment in terms of both impact and symptoms. This book will benefit readers as a single-source practical guide on development of modern PRO measures, as a blueprint to developing evidence generation plans related to PROs, and in offering useful suggestions on how to navigate recent developments shaping the field.
Autorenporträt
Paul Kamudoni PhD is an Associate Director for patient reported outcomes (PROs) in the global evidence and value development - R & D department at Merck KgaA in Darmstadt, Germany. Paul has a background in pharmacoeconomics and clinical outcomes measurement. His work is focused on developing new PRO measures as well as overseeing design and data analysis of PRO endpoints in clinical drug development programmes. Among others, his research interests include methodological issues in the integration of electronic health records with prospective PRO assessments, and the use of item response theory in PRO measure development, the design and development of disease-specific utility measures. Nutjaree Pratheepawanit Johns PhD PharmD is an Associate Professor at Faculty of Pharmaceutical Sciences, and melatonin research group, Khon Kaen University, Thailand. She has held a number of academic positions both in Thailand and abroad, including a 6-month fellowship at the Western Institutional Review Board (WIRB) (Olympia, WA, USA). Dr Johns has an expertise in cancer care and quality of life (QoL) research, and collaborates with many cancer centers in Northeastern Thailand. She has developed and tested many QoL and PRO measures including cross-cultural adaptation into Thai language. Dr Johns is also a principal investigator in many clinical trials investigating the effects of disease or interventions on QoL of cancer patients. She has been a recipient of a number of prestigious awards including Scholarship for Developing Country, International Society for Quality of Life Research and the Doyle Prize: Postgraduate section, Palliative Medicine Journal.Sam Salek PhD RPh FFPM FRPS MCMS FESCP is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Salek's research focuses mainly on four areas: development and application of PRO measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation & medicines development in the mature and emerging markets. He has published 22 books and 600+ journal articles and abstracts. Professor Salek is a member of five Editorial Boards and an active member of several societies.
Herstellerkennzeichnung:
Springer Verlag GmbH
Tiergartenstr. 17
69121 Heidelberg
DE
E-Mail: juergen.hartmann@springer.com
