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This book serves as a roadmap for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts, as a practical guide. To elucidate on key concepts in the book, examples from clinical research in hyperhidrosis and health-related quality of life and medicines clinical development context, are used. 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 PROs to patients with chronic disease and how such outcomes can assist clinicians in managing patients and monitoring their response to treatment in terms of both symptoms and impacts. This book will benefit readers as a single-source practical guide on the development of modern PRO measures and may also serve as a blueprint for the conceptualization and planning of evidence generation related to PROs in various settings. Ideas and suggestions on how to navigate recent developments shaping the field of PRO measurement are also offered. Dr Paul Kamudoni (PhD MSc.) is a Scientific Associate Director in the Global Evidence and Value Development – R&D department at Merck KgaA in Darmstadt (Germany) where he leads the Centre of Excellence for Patient Reported Outcomes. Dr Kamudoni trained as a Pharmacoeconomist and a Clinical Outcome Measurement Scientist at Cardiff University. In his day to day work, he is involved in the development and validation of PRO measures, and the design and integration of PRO endpoints in clinical trials and other types of studies. He maintains an active research interest in methodological issues in the integration of electronic health records with prospective PRO assessments, and the application of item response theory in PRO measurement among others. Dr Nutjaree Pratheepawanit Johns (PhD PharmD) is an Associate Professor at the 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 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 several cancer centres in Northeastern Thailand. She has developed and tested a number of PRO measures including cross-cultural adaptation into the 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 several prestigious awards including Scholarship for Developing Country, International Society for Quality of Life Research and the Doyle Prize: Postgraduate section, Palliative Medicine Journal. Professor 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.

Outcome assessment (Medical care) --- Chronically ill. --- Chronic diseases --- Sick --- Assessment of outcome (Medical care) --- Outcome evaluation (Medical care) --- Outcome measures (Medical care) --- Outcomes assessment (Medical care) --- Outcomes measurement (Medical care) --- Outcomes research (Medical care) --- Patient outcome assessment --- Medical care --- Patients --- Evaluation --- Quality of Life --- Quality of Life Research. --- Research. --- Life, Quality of --- Economic history --- Human ecology --- Life --- Social history --- Basic needs --- Human comfort --- Social accounting --- Work-life balance --- Medical research. --- Biomedical research --- Medical research

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This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed, and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Qualitative methods in social research --- Sociology --- Pharmacology. Therapy --- Human medicine --- sociologie --- medisch onderzoek --- farmacologie --- levenskwaliteit --- drugbeleid

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The Middle East represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region. This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients’ access to new medicines. Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Medicine & Public Health. --- Public Health. --- Pharmacotherapy. --- Medicine/Public Health, general. --- Medicine. --- Public health. --- Médecine --- Santé publique --- Public Health --- Health & Biological Sciences --- Public Health - General --- Pharmacy --- Drugs --- Law and legislation --- Medicaments --- Medications --- Medicine (Drugs) --- Medicines (Drugs) --- Pharmaceuticals --- Prescription drugs --- Bioactive compounds --- Medical supplies --- Pharmacopoeias --- Chemotherapy --- Materia medica --- Pharmacology --- Chemistry --- Medicine --- Drug therapy --- Pharmacotherapy --- Therapeutics --- Community health --- Health services --- Hygiene, Public --- Hygiene, Social --- Public health services --- Public hygiene --- Social hygiene --- Health --- Human services --- Biosecurity --- Health literacy --- Medicine, Preventive --- National health services --- Sanitation