This book describes some of the key epidemiological principles, scientific approaches and quality assurance frameworks required to design and conduct biobank studies in various settings. Using examples from contemporary biobanks, the book addresses the design features and practical procedures needed in order to launch and manage biobank studies, including consent and regulatory approval, the organisation of field work, management of data and biological samples, follow-up and verification of disease outcomes, development of IT systems for data collection, quality assurance and study management.
Over the last two decades, several large biobank studies have been initiated in different populations, intended to greatly enhance the development of precision medicine. Contemporary biobank studies are extremely large and complex, and involve several decades of follow-up. Such studies pose major challenges in terms of ensuring rapid recruitment, obtaining high-quality data, minimising loss to follow-up, reliably classifying disease outcomes, and optimising the use of the biological samples collected. In this regard, the key to success lies not in planning the perfect study, but in planning the most appropriate, reliable, sustainable and future-proof study given the practical constraints of available resources, time and capacity.
The authors of this handbook are epidemiologists, clinicians, software engineers, and laboratory and data scientists with extensive experience in conducting large biobank studies. The eight chapters can be read separately or together, and provide readers with essential information on how to design, implement and manage these studies. The state-of-the-art, innovative and scalable approaches and methodologies presented here are intended to stimulate the development of further population-based and hospital-based biobank studies in diverse populations.
About the Author: Zhengming Chen is a Professor of Epidemiology at the Nuffield Department of Population Health, University of Oxford, UK. He qualified in Medicine at Shanghai Medical University in China in 1983 and obtained a DPhil in Epidemiology from the University of Oxford in 1992. His main research focus has been on the determinants of chronic disease and advancement of evidence-based medicine. Since the mid-1990s, he has initiated and conducted several large prospective cohort studies and randomised trials of treatment for heart attack, stroke and cancer, yielding important findings that have since changed clinical practices and health policies worldwide. Most notably, he initiated, designed and co-directs, as the UK study PI, the China Kadoorie Biobank (CKB) study of over 500,000 adults, which has applied innovative approaches and methodologies for participant recruitment, data collection, quality assurance, study management and follow-up. He currently leads a large research team in Oxford, with expertise in epidemiology, population health, genomic medicine, and data science.
