Best Practices for Secondary Analyses in Clinical Trials

In this episode, Mo and Marc discuss best practices and common challenges in planning secondary analyses from clinical trials, including data collection and analysis protocols, the distinction between primary and secondary questions, hypothesis-driven design, statistical power, process transparency, and dissemination strategies.    Subspecialties:  Trauma  Orthopaedic Essentials    Links:  Shu HT, Hoveidaei AH, Reider LM, Vallier HA, Quinnan S, Gary JL, Carroll EA, Carlini AR, Higgins TF, Bosse MJ, Shafiq B, Tornetta P 3rd, O'Toole RV, Castillo RC; METRC (Major Extremity Trauma Research Consortium). Pain Outcomes Following Modern External Ring Fixation Compared with Internal Fixation for Severe Open Tibial Fractures: A Secondary Analysis of a Prospective Randomized Trial (FIXIT). J Bone Joint Surg Am. 2026 May 6;108(9):649-657. doi: 10.2106/JBJS.25.00964. Epub 2026 Mar 18. PMID: 41849563. https://bit.ly/4fl6E12  Chapters (00:00:03) - Ortho Joe Podcast(00:00:51) - Conflict of Interest(00:02:12) - Ring External Fixation vs Internal Fixation for Fracture(00:05:17) - Primary and Secondary Analysis(00:09:54) - The study power of the FLAT trial(00:11:14) - How to manage the secondary analysis in a clinical trial(00:13:39) - Primary analysis in a randomized trial(00:15:14) - Exclusivity in large trials