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Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.
Seltzer JH, Heise T, Carson P, Canos D, Hiatt JC, Vranckx P, Christen T, Cutlip DE. Seltzer JH, et al. Am Heart J. 2017 Aug;190:76-85. doi: 10.1016/j.ahj.2017.05.009. Epub 2017 May 28. Am Heart J. 2017. PMID: 28760216 Review.
Critical Appraisal of Contemporary Clinical Endpoint Definitions in Coronary Intervention Trials: A Guidance Document.
Spitzer E, McFadden E, Vranckx P, Garcia-Garcia HM, Seltzer JH, Held C, de Vries T, Menon V, Brown KJ, Soliman OII, Onuma Y, Lopes RD, Stone GW, Cutlip DE, Serruys PW. Spitzer E, et al. Among authors: seltzer jh. JACC Cardiovasc Interv. 2019 May 13;12(9):805-819. doi: 10.1016/j.jcin.2018.12.031. JACC Cardiovasc Interv. 2019. PMID: 31072504 Free article. Review.
Assessing cardiac safety in oncology drug development.
Seltzer JH, Gintant G, Amiri-Kordestani L, Singer J, Koplowitz LP, Moslehi JJ, Barac A, Yu AF. Seltzer JH, et al. Am Heart J. 2019 Aug;214:125-133. doi: 10.1016/j.ahj.2019.04.010. Epub 2019 May 4. Am Heart J. 2019. PMID: 31202099 Free PMC article. Review. No abstract available.
Novel oral anticoagulants and reversal agents: Considerations for clinical development.
Sarich TC, Seltzer JH, Berkowitz SD, Costin' J, Curnutte JT, Gibson CM, Hoffman M, Kaminskas E, Krucoff MW, Levy JH, Mintz PD, Reilly PA, Sager PT, Singer DE, Stockbridge N, Weitz JI, Kowey PR. Sarich TC, et al. Among authors: seltzer jh. Am Heart J. 2015 Jun;169(6):751-7. doi: 10.1016/j.ahj.2015.03.010. Epub 2015 Mar 26. Am Heart J. 2015. PMID: 26027611
Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock.
Samsky MD, Krucoff MW, Morrow DA, Abraham WT, Aguel F, Althouse AD, Chen E, Cigarroa JE, DeVore AD, Farb A, Gilchrist IC, Henry TD, Hochman JS, Kapur NK, Morrow V, Ohman EM, O'Neill WW, Piña IL, Proudfoot AG, Sapirstein JS, Seltzer JH, Senatore F, Shinnar M, Simonton CA, Tehrani BN, Thiele H, Truesdell AG, Waksman R, Rao SV. Samsky MD, et al. Among authors: seltzer jh. Am Heart J. 2020 Dec;230:93-97. doi: 10.1016/j.ahj.2020.09.015. Epub 2020 Oct 2. Am Heart J. 2020. PMID: 33011148 Free PMC article. No abstract available.
32 results