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Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.
Rossignol P, Agarwal R, Canaud B, Charney A, Chatellier G, Craig JC, Cushman WC, Gansevoort RT, Fellström B, Garza D, Guzman N, Holtkamp FA, London GM, Massy ZA, Mebazaa A, Mol PGM, Pfeffer MA, Rosenberg Y, Ruilope LM, Seltzer J, Shah AM, Shah S, Singh B, Stefánsson BV, Stockbridge N, Stough WG, Thygesen K, Walsh M, Wanner C, Warnock DG, Wilcox CS, Wittes J, Pitt B, Thompson A, Zannad F. Rossignol P, et al. Among authors: seltzer j. Eur Heart J. 2019 Mar 14;40(11):880-886. doi: 10.1093/eurheartj/ehx209. Eur Heart J. 2019. PMID: 28431138 Free PMC article.
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
Responsibilities of Data Monitoring Committees: Consensus Recommendations.
Bierer BE, Li R, Seltzer J, Sleeper LA, Frank E, Knirsch C, Aldinger CE, Levine RJ, Massaro J, Shah A, Barnes M, Snapinn S, Wittes J. Bierer BE, et al. Among authors: seltzer j. Ther Innov Regul Sci. 2016 Sep;50(5):648-659. doi: 10.1177/2168479016646812. Epub 2016 Jul 10. Ther Innov Regul Sci. 2016. PMID: 30231760
Clinical events classification (CEC) in clinical trials: Report on the current landscape and future directions - proceedings from the CEC Summit 2018.
Sharma A, Mahaffey KW, Gibson CM, Hicks KA, Alexander KP, Ali M, Chaitman BR, Held C, Hlatky M, Jones WS, Mehran R, Menon V, Rockhold FW, Seltzer J, Spitzer E, Wilson M, Lopes RD. Sharma A, et al. Among authors: seltzer j. Am Heart J. 2022 Apr;246:93-104. doi: 10.1016/j.ahj.2021.12.012. Epub 2021 Dec 31. Am Heart J. 2022. PMID: 34973948 Free article.
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.
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.
302 results