دانلود کتاب راهنمای تحقیقات بالینی و بهداشتی آکسفورد

This book was commissioned to integrate guidance on how to conduct both clinical as well as healthcare-related research. There are a multitude of texts on clinical research alone and also stand-alone books on broader healthcare-related research methods. In our handbook we have tried to combine both of these skill-sets as seamlessly as possible, whilst pointing out where the main differences lie. Since starting this handbook there have been a number of significant changes to the clinical research landscape as well as the drug development process, both in Europe and also globally. In clinical trials, much more emphasis is now placed on patient outcomes as well as demonstrating efficacy, whilst the ever widening scope of healthcare-related research ranges from quantitative analyses of ‘big data’ across populations to in-depth qualitative and educational/behavioural studies in individuals. The common denominator unifying both clinical and wider healthcare-related research is the need to ensure high quality data and the ability to readily translate findings for the benefit if patients and the public. This joint mission has resulted in convergence of the disciplines that underpin clinical and healthcare research. The handbook is split broadly into three sections. Let us consider each section in turn, through the story of five fictitious but fairly typical examples of students/trainees, each about to undertake research as part of their degrees/training: Adam (Master’s Student in Nursing), Betty (Pre-Registration Pharmacist), Jing (Medical Doctor in Academic Training), Khaled (Physiotherapist in Research Training), and Vidya (Nutrition and Dietetics Graduate on a PhD Programme). All five meet at a Research Symposium and stumble upon this handbook as a recommended resource. The first section deals with basic research methods. The chapters start from the conceptual point of why we conduct research and the bedrock of quantitative and qualitative know-how required as a first step towards the investigation of any research question. This section also outlines how evidence-based medicine and critical appraisal are utilized in an applied research setting. Adam, Betty, Jing, Khaled, and Vidya all find this section equally beneficial. Adam, who is undertaking a qualitative piece of educational research draws mostly from the chapter written specifically in this area. Vidya finds the basics of statistics and epidemiology most relevant to strengthen concepts. Jing uses the critical appraisal section for weekly journal clubs. The second section deals with general research process. The chapters deal with the regulatory environment, ethical, and safety requirements when conducting a research project. The management of clinical research is discussed and we take the reader through the life cycle of a research project from concept to fruition and publication. All five characters in our story use the material from this section as a toolkit to help navigate their individual research journeys. The third section also concentrates on research process but the exacting requirements of clinical trials in investigational products are detailed and where there are significant differences in healthcare research these are discussed. Khaled finds this section useful to delineate where the similarities and differences lie in the methods and compliance measures required for his trials of non-pharmaceutical treatments. Betty and Jing both find that this section is particularly relevant to their aspirations of becoming a research pharmacist, and clinical trialist, respectively. Vidya finds this section useful to help decide that her research would be of a dietary rather than nutraceutical nature. Adam uses this section for continuing professional development. No matter whether the users of this handbook are students, trainees or professionals, like our five fictitious characters, we are sure that this will prove a useful resource both to the uninitiated as well as those looking to read across horizontally between methodologies. Throughout the book we provide examples wherever possible, key references and signposting to other useful resources, including weblinks which can be accessed for updates in this continuously moving field of clinical and healthcare research. We hope that this handbook will serve as a faithful companion to all those undertaking clinical and healthcare research both across professions as well as across the globe and we look forward to shaping future editions to the evolving needs of a professionally diverse audience.