Pragmatic clinical trial (PCT) designs, particularly ones that use cluster randomization or other novel methods, pose challenges during the study design phase (Cook et al, 2016). Here, we briefly examine some current challenges in PCT design, as well as potential solutions and future directions for further exploration.
Cook AJ, Delong E, Murray DM, Vollmer WM, Heagerty PJ. 2016. Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core. Clin Trials. 13:504-512. doi:10.1177/1740774516646578. PMID: 27179253.