Lessons Learned from Trial Replication Analyses: Findings from the DUPLICATE Demonstration Project


Public Workshop

Lessons Learned from Trial Replication Analyses: Findings from the DUPLICATE Demonstration Project

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This U.S. Food and Drug Administration public workshop, convened through a grant with the Duke-Margolis Center for Health Policy, will review findings from the RCT-DUPLICATE Demonstration Project. The discussion will build on a previous public workshop convened by Duke-Margolis on February 16, 2021, which shared preliminary results from trial replication efforts with the goal of better understanding the strengths and limitations of observational studies. The current workshop will report on additional results and further elaborate on lessons learned from RCT-DUPLICATE; potential implications for regulatory decision-making will also be explored.

Background reading: 

  • Dahabreh IJ, Haneuse SJA, Robins JM, Robertson SE, Buchanan AL, Stuart EA, Hernán MA. Study Designs for Extending Causal Inferences From a Randomized Trial to a Target Population. Am J Epidemiol. 2021 Aug 1;190(8):1632-1642. doi: 10.1093/aje/kwaa270. PMID: 33324969; PMCID: PMC8536837. (link)
  • Dahabreh IJ, Robins JM, Hernán MA. Benchmarking Observational Methods by Comparing Randomized Trials and Their Emulations. Epidemiology. 2020 Sep;31(5):614-619. doi: 10.1097/EDE.0000000000001231. PMID: 32740470. (link)
  • Hernán MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18. PMID: 26994063; PMCID: PMC4832051. (link)
  • Forbes SP, Dahabreh IJ. Benchmarking Observational Analyses Against Randomized Trials: a Review of Studies Assessing Propensity Score Methods. J GEN INTERN MED 35, 1396–1404 (2020). (link) 
  • Franklin JM, Glynn RJ, Martin D, Schneeweiss S. Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making. Clin Pharmacol Ther. 2019 Apr;105(4):867-877. doi: 10.1002/cpt.1351. Epub 2019 Feb 25. PMID: 30636285. (link)
  • Franklin JM, Glynn RJ, Suissa S, Schneeweiss S. Emulation Differences vs. Biases When Calibrating Real-World Evidence Findings Against Randomized Controlled Trials. Clin Pharmacol Ther. 2020 Apr;107(4):735-737. doi: 10.1002/cpt.1793. Epub 2020 Feb 12. PMID: 32052415; PMCID: PMC7233792. (link) 
  • Franklin JM, Pawar A, Martin D, Glynn RJ, Levenson M, Temple R, Schneeweiss S. Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project. Clin Pharmacol Ther. 2020 Apr;107(4):817-826. doi: 10.1002/cpt.1633. Epub 2019 Oct 25. PMID: 31541454. (link)
  • Franklin JM, Patorno E, Desai RJ, Glynn RJ, Martin D, Quinto K, Pawar A, Bessette LG, Lee H, Garry EM, Gautam N, Schneeweiss S. Emulating Randomized Clinical Trials with Nonrandomized Real-World Evidence Studies: First Results from the RCT DUPLICATE Initiative. Circulation. 2020 Dec 17. doi: 10.1161/CIRCULATIONAHA.120.051718. Epub ahead of print. PMID: 33327727. (link)
  • Franklin JM, Schneeweiss S. When and How Can Real World Data Analyses Substitute for Randomized Controlled Trials? Clin Pharmacol Ther. 2017 Dec;102(6):924-933. doi: 10.1002/cpt.857. Epub 2017 Sep 25. PMID: 28836267. (link) 
  • Olson MS, Deshpande C, Kahler KH. Letter by Olson et al Regarding Article, "Emulating Randomized Clinical Trials With Nonrandomized Real-World Evidence Studies: First Results From the RCT DUPLICATE Initiative". Circulation. 2021 Aug 24;144(8):e161. doi: 10.1161/CIRCULATIONAHA.121.053935. Epub 2021 Aug 23. PMID: 34424767. (link)


Acknowledgement of Federal Support

Funding for this event was made possible, in part, by the Food and Drug Administration through grant U01FD006807. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.