How to improve the study design of clinical trials in internal medicine: Recent advances in the evidence-based methodology

Abstract

Meta-research has highlighted that up to half of all clinical studies may be redundant and do not add any value. We suggest that such unnecessary studies will continue to be prepared and published unless researchers systematically and transparently identify and consider the existing evidence. This approach of identifying and utilizing the existing knowledge base before and after conducting a new trial is called Evidence-Based Research (EBR), defined as the use of prior research in a systematic and transparent way to inform a new study so that it is answering questions that matter in a valid, efficient, and accessible manner. This paper describes the issues that have led to the development of the EBR approach, suggests what researchers should do to avoid wasteful and unnecessary research, and outlines the benefits of conducting evidence-based research. Finally, we present the international EBR Network established to support the efforts to minimize waste in research and increase the value of clinical studies.