A framework for clinical and translational research in the era of rigor and reproducibility

• Published in: Journal of clinical and translational science Vol. 5; no. 1; p. e31
• Main Authors: Wichman, Chris, Smith, Lynette M, Yu, Fang
• Format: Journal Article
• Language: English
• Published: England Cambridge University Press 01.01.2021
• Subjects: Blood pressure; clinical translational research; Clinical trials; Data collection; Data Science in Clinical and Translational Research; Health services; Hypotheses; Intervention; Lung cancer; Non-small cell lung carcinoma; Protein-tyrosine kinase; Public health; replicability; Reproducibility; Rigor; Small cell lung carcinoma; team science; Translation; Translational Research, Design and Analysis; clinical translational research; team science; replicability; reproducibility; Rigor
• ISSN: 2059-8661; 2059-8661
• DOI: 10.1017/cts.2020.523

Rigor and reproducibility are two important cornerstones of medical and scientific advancement. Clinical and translational research (CTR) contains four phases (T1-T4), involving the translation of basic research to humans, then to clinical settings, practice, and the population, with the ultimate goal of improving public health. Here we provide a framework for rigorous and reproducible CTR. In this paper we define CTR, provide general and phase-specific recommendations for improving quality and reproducibility of CTR with emphases on study design, data collection and management, analyses and reporting. We present and discuss aspects of rigor and reproducibility following published examples of CTR from the literature, including one example that shows the development path of different treatments that address anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). It is particularly important to consider robust and unbiased experimental design and methodology for analysis and interpretation for clinical translation studies to ensure reproducibility before taking the next translational step. There are both commonality and differences along the clinical translation research phases in terms of research focuses and considerations regarding study design, implementation, and data analysis approaches. Sound scientific practices, starting with rigorous study design, transparency, and team efforts can greatly enhance CTR. Investigators from multidisciplinary teams should work along the spectrum of CTR phases, and identify optimal practices for study design, data collection, data analysis, and results reporting to allow timely advances in the relevant field of research.