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An adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: Rationale and proposal
dc.contributor.authorTolles, Juliana
dc.contributor.authorBeiling, Marissa
dc.contributor.authorSchreiber, Martin A.
dc.contributor.authorDel Junco, Deborah J.
dc.contributor.authorMcMullan, Jason T.
dc.contributor.authorGuyette, Francis X.
dc.contributor.authorWang, Henry
dc.contributor.authorJansen, Jan O.
dc.contributor.authorMeurer, William J.
dc.contributor.authorMainali, Shraddha
dc.contributor.authorYadav, Kabir
dc.contributor.authorLewis, Roger J.
dc.date.accessioned2022-08-02T18:57:15Z
dc.date.available2023-09-02 14:57:14en
dc.date.available2022-08-02T18:57:15Z
dc.date.issued2022-08
dc.identifier.citationTolles, Juliana; Beiling, Marissa; Schreiber, Martin A.; Del Junco, Deborah J.; McMullan, Jason T.; Guyette, Francis X.; Wang, Henry; Jansen, Jan O.; Meurer, William J.; Mainali, Shraddha; Yadav, Kabir; Lewis, Roger J. (2022). "An adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: Rationale and proposal." Transfusion 62: S231-S241.
dc.identifier.issn0041-1132
dc.identifier.issn1537-2995
dc.identifier.urihttps://hdl.handle.net/2027.42/173104
dc.publisherJohn Wiley & Sons, Inc.
dc.subject.otherhemorrhagic shock
dc.subject.othermedical ethics
dc.subject.otherplatform trials
dc.subject.othertrauma resuscitation
dc.subject.otherexception from informed consent
dc.subject.otheradaptive trials
dc.subject.otherclinical trial design
dc.titleAn adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: Rationale and proposal
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelOncology and Hematology
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/173104/1/trf16957_am.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/173104/2/trf16957.pdf
dc.identifier.doi10.1111/trf.16957
dc.identifier.sourceTransfusion
dc.identifier.citedreferencedel Junco DJ, Neal MD, Shackelford SA, Spinella PC, Guyette FX, Sperry JL, et al. An adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: planning and execution. Transfusion. 2022.
dc.identifier.citedreferenceWoodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med. 2017; 377 ( 1 ): 62 – 70. https://doi.org/10.1056/NEJMra1510062 PMID: 28679092.
dc.identifier.citedreferenceBerry SM, Connor JT, Lewis RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA. 2015; 313 ( 16 ): 1619 – 20. https://doi.org/10.1001/jama.2015.2316 PMID: 25799162.
dc.identifier.citedreferenceTolles J, Lewis RJ ( 2018 ). Adaptive and platform trials in remote damage control resuscitation. J Trauma Acute Care Surg, Jun; 84 ( 6S Suppl 1 ): S28 - S34. doi: https://doi.org/10.1097/TA.0000000000001904. PMID: 29554037
dc.identifier.citedreferenceSaville BR, Berry SM. Efficiencies of platform clinical trials: a vision of the future. Clin Trials. 2016; 13 ( 3 ): 358 – 66. https://doi.org/10.1177/1740774515626362 Epub 2016 Feb 17. PMID: 26908536.
dc.identifier.citedreferenceViele K, Saville BR, McGlothlin A, Broglio K. Comparison of response adaptive randomization features in multiarm clinical trials with control. Pharm Stat. 2020; 19 ( 5 ): 602 – 12. https://doi.org/10.1002/pst.2015 Epub 2020 Mar 21. PMID: 32198968.
dc.identifier.citedreferenceViele K, Broglio K, McGlothlin A, Saville BR. Comparison of methods for control allocation in multiple arm studies using response adaptive randomization. Clin Trials. 2020; 17 ( 1 ): 52 – 60. https://doi.org/10.1177/1740774519877836 Epub 2019 Oct 19. PMID: 31630567.
dc.identifier.citedreferenceMeurer WJ, Lewis RJ, Berry DA. Adaptive clinical trials: a partial remedy for the therapeutic misconception? JAMA. 2012; 307 ( 22 ): 2377 – 8. https://doi.org/10.1001/jama.2012.4174
dc.identifier.citedreferenceLondon AJ. Learning health systems, clinical equipoise and the ethics of response adaptive randomization. J Med Ethics. 2018; 44: 409 – 15.
dc.identifier.citedreferenceUS Food and Drug Administration Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-use-bayesian-statistics-medical-device-clinical-trials. Accessed April 29, 2022.
dc.identifier.citedreferenceGelman A, Carlin JB, Stern HS, Rubin DB. Bayesian Data Analysis. 2nd ed. Boca Raton: Texts in Statistical Science. Chapman & Hall/CRC; 2003.
dc.identifier.citedreferenceUPMC REMAP-COVID Group, on behalf of the REMAP-CAP Investigators. Implementation of the randomized embedded multifactorial adaptive platform for COVID-19 (REMAP-COVID) trial in a US health system-lessons learned and recommendations. Trials. 2021; 22 ( 1 ): 100. https://doi.org/10.1186/s13063-020-04997-6 Erratum in: Trials. 2021 Feb 16;22(1):145. PMID: 33509275; PMCID: PMC7841377.
dc.identifier.citedreferenceAngus DC, Berry S, Lewis RJ, Al-Beidh F, Arabi Y, van Bentum-Puijk W, et al. The REMAP-CAP (randomized embedded multifactorial adaptive platform for community-acquired pneumonia) study. Rationale and design. Ann Am Thorac Soc. 2020; 17 ( 7 ): 879 – 91. https://doi.org/10.1513/AnnalsATS.202003-192SD PMID: 32267771; PMCID: PMC7328186.
dc.identifier.citedreferenceATTACC Investigators; ACTIV-4a Investigators; REMAP-CAP Investigators, Lawler PR, Goligher EC, Berger JS, Neal MD, BJ MV, et al. Therapeutic anticoagulation with heparin in noncritically ill patients with Covid-19. N Engl J Med. 2021; 385 ( 9 ): 790 – 802. https://doi.org/10.1056/NEJMoa2105911 Epub 2021 Aug 4. PMID: 34351721; PMCID: PMC8362594.
dc.identifier.citedreferenceREMAP-CAP Investigators; ACTIV-4a Investigators; ATTACC Investigators, Goligher EC, Bradbury CA, McVerry BJ, Lawler PR, Berger JS, et al. Therapeutic anticoagulation with heparin in critically ill patients with Covid-19. N Engl J Med. 2021; 385 ( 9 ): 777 – 89. https://doi.org/10.1056/NEJMoa2103417 Epub 2021 Aug 4. PMID: 34351722; PMCID: PMC8362592.
dc.identifier.citedreferenceWriting Committee for the REMAP-CAP Investigators, Estcourt LJ, Turgeon AF, ZK MQ, McVerry BJ, Al-Beidh F, et al. Effect of convalescent plasma on organ support-free days in critically ill patients with COVID-19: a randomized clinical trial. JAMA. 2021; 326 ( 17 ): 1690 – 702. https://doi.org/10.1001/jama.2021.18178 PMID: 34606578; PMCID: PMC8491132.
dc.identifier.citedreferenceArabi YM, Gordon AC, Derde LPG, Nichol AD, Murthy S, Beidh FA, et al. Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial. Intensive Care Med. 2021; 47 ( 8 ): 867 – 86. https://doi.org/10.1007/s00134-021-06448-5 Epub 2021 Jul 12. PMID: 34251506; PMCID: PMC8274471.
dc.identifier.citedreferenceAngus DC, Derde L, Al-Beidh F, Annane D, Arabi Y, Beane A, et al. Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19: the REMAP-CAP COVID-19 corticosteroid domain randomized clinical trial. JAMA. 2020; 324 ( 13 ): 1317 – 29. https://doi.org/10.1001/jama.2020.17022 PMID: 32876697; PMCID: PMC7489418.
dc.identifier.citedreferenceGoldkind SF, Brosch LR, Lewis RJ, Pedroza C, Spinella PC, Shackelford SA, et al. An adaptive platform trial for evaluating treatments in patients with life-threatening hemorrhage from traumatic injuries: ethical and US regulatory considerations. Transfusion. 2022.
dc.identifier.citedreferenceHolcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, et al. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015; 313 ( 5 ): 471 – 82. https://doi.org/10.1001/jama.2015.12
dc.identifier.citedreferenceCallum J, Farkouh ME, Scales DC, Heddle NM, Crowther M, Rao V, et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery: the FIBRES randomized clinical trial. JAMA. 2019; 322 ( 20 ): 1966 – 76. https://doi.org/10.1001/jama.2019.17312
dc.identifier.citedreferenceBroglio K. Randomization in clinical trials: permuted blocks and stratification. JAMA. 2018; 319 ( 21 ): 2223 – 4. https://doi.org/10.1001/jama.2018.6360
dc.identifier.citedreferenceAustin PC, Lee DS, Fine JP. Introduction to the analysis of survival data in the presence of competing risks. Circulation. 2016; 133 ( 6 ): 601 – 9. https://doi.org/10.1161/CIRCULATIONAHA.115.017719 PMID: 26858290; PMCID: PMC4741409.
dc.identifier.citedreferenceSpinella PC, El Kassar N, Cap AP, Kindzelski AL, Almond CS, Barkun A, et al. Hemostasis trials outcomes working group. Recommended primary outcomes for clinical trials evaluating hemostatic blood products and agents in patients with bleeding: proceedings of a National Heart Lung and blood institute and US Department of defense consensus conference. J Trauma Acute Care Surg. 2021; 91 ( 2S Suppl 2 ): S19 – 25. https://doi.org/10.1097/TA.0000000000003300 PMID: 34039915.
dc.identifier.citedreferenceHolcomb JB, Moore EE, Sperry JL, Jansen JO, Schreiber MA, Del Junco DJ, et al. Evidence-based and clinically relevant outcomes for hemorrhage control trauma trials. Ann Surg. 2021; 273 ( 3 ): 395 – 401. https://doi.org/10.1097/SLA.0000000000004563 PMID: 33065652.
dc.identifier.citedreferenceKwok H, Lewis RJ. Bayesian hierarchical modeling and the integration of heterogeneous information on the effectiveness of cardiovascular therapies. Circ Cardiovasc Qual Outcomes. 2011; 4 ( 6 ): 657 – 66. https://doi.org/10.1161/CIRCOUTCOMES.111.960724 PMID: 22085987.
dc.identifier.citedreferenceBerry SM, Reese CS, Larkey PD. Bridging different eras in sports. J Am Stat Assoc. 1999; 94 ( 447 ): 661 – 76. https://doi.org/10.1080/01621459.1999.10474163
dc.identifier.citedreferencePark JJH, Detry MA, Murthy S, Guyatt G, Mills EJ. How to use and interpret the results of a platform trial: Users’ guide to the medical literature. JAMA. 2022; 327 ( 1 ): 67 – 74. https://doi.org/10.1001/jama.2021.22507
dc.identifier.citedreferenceElm JJ, Palesch YY, Koch GG, Hinson V, Ravina B, Zhao W. Flexible analytical methods for adding a treatment arm mid-study to an ongoing clinical trial. J Biopharm Stat. 2012; 22 ( 4 ): 758 – 72. https://doi.org/10.1080/10543406.2010.528103
dc.identifier.citedreferenceVillar SS, Bowden J, Wason J. Response-adaptive designs for binary responses: how to offer patient benefit while being robust to time trends? Pharm Stat. 2018; 17 ( 2 ): 182 – 97. https://doi.org/10.1002/pst.1845
dc.identifier.citedreferenceLee KM, Wason J. Including non-concurrent control patients in the analysis of platform trials: is it worth it? BMC Med Res Methodol. 2020; 20: 165. https://doi.org/10.1186/s12874-020-01043-6
dc.identifier.citedreferenceMcGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA. 2014; 312 ( 13 ): 1342 – 3. https://doi.org/10.1001/jama.2014.13128
dc.identifier.citedreferenceCode of Federal Regulations Title 21 50.24(d). Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=50.24. Accessed November 28, 2021.
dc.identifier.citedreferenceNational Center for Health Statistics, Centers for Disease Control and Prevention. Leading Causes of Death and Numbers of Deaths, by Age: United States, 1980 and 2018. Available at http://www.cdc.gov/nchs/hus/contents2019.htm#Table-007 accessed December 1, 2021.
dc.identifier.citedreferenceTisherman SA, Stein DM. ICU Management of Trauma Patients. Crit Care Med. 2018; 46 ( 12 ): 1991 – 7. https://doi.org/10.1097/CCM.0000000000003407
dc.identifier.citedreferenceJones CM, Cushman JT, Lerner EB, Fisher SG, Seplaki CL, Veazie PJ, et al. Prehospital trauma triage decision-making: a model of what happens between the 9-1-1 call and the hospital. Prehosp Emerg Care. 2016; 20 ( 1 ): 6 – 14. https://doi.org/10.3109/10903127.2015.1025157
dc.identifier.citedreferenceSchafer N, Driessen A, Frohlich M, Sturmer EK, Maegele M, TACTIC partners. Diversity in clinical management and protocols for the treatment of major bleeding trauma patients across European level I trauma Centres. Scand J Trauma Resusc Emerg Med. 2015; 23: 74. https://doi.org/10.1186/s13049-015-0147-6
dc.identifier.citedreferenceSpinella PC. Zero preventable deaths after traumatic injury: an achievable goal. J Trauma Acute Care Surg. 2017; 82 ( 6S Suppl 1 ): S2 – 8. https://doi.org/10.1097/TA.0000000000001425
dc.identifier.citedreferenceCarroll SL, Dye DW, Smedley WA, Stephens SW, Reiff DA, Kerby JD, et al. Early and prehospital trauma deaths: who might benefit from advanced resuscitative care? J Trauma Acute Care Surg. 2020; 88 ( 6 ): 776 – 82. https://doi.org/10.1097/TA.0000000000002657
dc.identifier.citedreferenceAngus DC, Chang CH. Heterogeneity of treatment effect: estimating how the effects of interventions vary across individuals. JAMA. 2021; 326 ( 22 ): 2312 – 3. https://doi.org/10.1001/jama.2021.20552
dc.identifier.citedreferenceChampion HR, Fingerhut A, Escobar MA, Weiskopf RB. The role of data and safety monitoring in acute trauma resuscitation research. J Am Coll Surg. 2007; 204 ( 1 ): 73 – 83. https://doi.org/10.1016/j.jamcollsurg.2006.10.024
dc.identifier.citedreferenceUS Food and Drug Administration. Adaptive Designs for Clinical Trials of Drugs and Biologics Guidance for Industry. Available at https://www.fda.gov/media/78495/download. Accessed November 19, 2021.
dc.identifier.citedreferenceBerry S, Carlin BP, Lee JJ, Muller P. Bayesian adaptive methods for clinical trials, Chapman & Hall/CRC biostatistics series. 2010.
dc.identifier.citedreferenceMeurer WJ, Lewis RJ, Tagle D, Fetters MD, Legocki L, Berry S, et al. An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project. Ann Emerg Med. 2012; 60 ( 4 ): 451 – 7. https://doi.org/10.1016/j.annemergmed.2012.01.020
dc.identifier.citedreferenceBhatt DL, Mehta C. Adaptive designs for clinical trials. N Engl J Med. 2016; 375 ( 1 ): 65 – 74. https://doi.org/10.1056/NEJMra1510061 PMID: 27406349.
dc.identifier.citedreferenceAdaptive Platform Trials Coalition. Adaptive platform trials: definition, design, conduct and reporting considerations. Nat Rev Drug Discov. 2019; 18 ( 10 ): 797 – 807. https://doi.org/10.1038/s41573-019-0034-3 Epub 2019 Aug 28. Erratum in: Nat Rev Drug Discov. 2019 Sep 10;: PMID: 31462747.
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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