Best Practices for Clinical and Translational Research and Implementation

Scientists in all sectors have been raising concerns in recent years about the lack of reproducibility of biomedical research results. An analysis of in-house validation efforts at Bayer HealthCare found that <25% of potential targets could be reproduced in-house.1 Similarly, of 53 “landmark” studies selected because they described completely new findings, only 11% could be confirmed in-house by Amgen scientists.2 Such dismal numbers have raised concern among scientists in all sectors about the lack of transparency in reporting scientific results and the need to share best laboratory and clinical practices. In response, more training in rigor and reproducibility, study design, and statistical analysis has been mandated by the National Institutes of Health.3 A NINDS task force was one of the first to call on journals to play a more important role in improving the impact of basic and translational research by requiring higher standards of evidence and access to detailed methods, code, and data for publication.4 In a climate where increasing research costs and reduced funding have changed the landscape of academic and private sector research, it is even more critical that all research is performed at the highest possible standards. Similarly, drug development costs continue to rise and a high level of scrutiny is given to the design and interpretation of preclinical and clinical studies in the pharmaceutical and biotechnology industries. The major factors underlying deficiencies in scientific rigor and reproducibility are gaps in training and the absence of widely available best practices. The fields of clinical and translational science are no exception. Clinical and translational research requires an interdisciplinary team of investigators. Clinicians and researchers with training in medicine, pharmacy, pharmacology, pharmaceutical sciences, and bioinformatics bring a diversity of skills and knowledge to the table; this presents both opportunities and challenges. While the breadth of training is critical for the interdisciplinary nature of translational research and medicine, the specialized training in most fields limits the tools and knowledge available to an individual researcher. To address this need, Clinical and Translational Science is launching a tutorial section. Focusing on important and timely topics of relevance to the broad field of clinical pharmacology and translational medicine, tutorials will provide practical advice