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Empowering Clinical Researchers Through Shared Content and Knowledge
Clinical research in the field of global health is an essential component of medical breakthroughs, establishing practices, and ensuring a thorough understanding of human disease, preventing and treating illness, and promoting health. However, reliable clinical research data is sometimes lacking in global health situations, so it is imperative to establish effective and ethical conduct in researchers around the world.
To help with this mission, the US National Institutes of Health (NIH), Indian Council of Medical Research, and the Department of Biotechnology conducted a week-long session during April 2018 in Hyderabad, India to train the next generation of clinical researchers on the best principles and practice of clinical research. One hundred students participated in the course, representing 89 institutions from various parts of India. The students covered a broad range of topics critical to conducting clinical research including epidemiologic methods study design, protocol preparation, patient monitoring, ethical considerations, quality assurance, and data management. Six US faculty, four from NIH, one from FDA and one from the Office of the Secretary Department of Health and Human Services successfully interacted with 17 faculty from India to provide an outstanding program.
To support this program, Elsevier donated electronic copies of the newly published Principles and Practices of Clinical Research, Fourth Edition, edited by Dr. John Gallin (Chief Scientific Officer, Clinical Center, Associate Director for Clinical Research, National Institutes of Health), Dr. Frederick Ognibene (Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center and Director, Office of Clinical Research Training and Medical Education, NIH Clinical Center, National Institutes of Health), and Dr. Laura Lee Johnson (Associate Director, Division of Biometrics III, FDA/CDER Office of Biostatistics). This seminal text provided the students with a foundational resource explaining fundamental principles and the expanding practice of clinical research. New features of this edition such as a discussion on electronic health records and information resources for clinical researchers as well as chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting allowed for a deeper understanding of the history and current state of clinical research. The course was well-received and effective with the end-of-course examination seeing a pass percentage of 85% with 85 participants scoring 80% or above. The program shows the impact that international collaboration can have in securing the future of clinical research.
To read more about the principles and practice of clinical research, please see the excerpt below from Principles and Practices of Clinical Research, Fourth Edition.
“As science becomes increasingly complex, collaborative, and interdisciplinary, the need for a set of standards whereby research is conducted has become increasingly important. Both the researchers themselves and the institutions, where they work, from which their funding comes, and where they publish, have responsibilities to ensure that all research is conducted in an ethical manner, with utmost integrity. This chapter draws on materials that have been published over the past three decades to provide a set of fundamental principles that underlie the conduct of all aspects of research.”
Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications.
- Features input from experts in the field dedicated to translating scientific research from bench to bedside and back
- Provides expanded coverage of global clinical research
- Contains hands-on, practical suggestions, illustrations, and examples throughout
- Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting
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