Towards the development of a comprehensive framework: Qualitative systematic survey of definitions of clinical research quality Systematic survey of definitions of clinical research quality
Belinda von Niederhäusern, Stefan Schandelmaier, Marie Mi Bonde, Nicole Brunner, Lars G. Hemkens, Marielle Rutquist, Neera Bhatnagar, Gordon H. Guyatt, Christiane Pauli-Magnus, Matthias Briel, Roberta W. Scherer
Abstract
Clinical research is necessary to advance our knowledge and practice of diagnosing and preventing diseases and treating patients. However, its complexity and the regulatory requirements have significantly increased over the last few years, requiring an ever-rising level of scientific, methodological, regulatory and organizational know-how . Global clinical research involves billions of dollars and millions of people, yet it is often poorly planned, inefficient, or “not useful”, leading to considerable waste of private and public funding . Low quality research may not only result in misleading
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