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Assessing the Financial Value of Decentralized Clinical Trials.
DiMasi JA, Smith Z, Oakley-Girvan I, Mackinnon A, Costello M, Tenaerts P, Getz KA. DiMasi JA, et al. Among authors: tenaerts p. Ther Innov Regul Sci. 2023 Mar;57(2):209-219. doi: 10.1007/s43441-022-00454-5. Epub 2022 Sep 14. Ther Innov Regul Sci. 2023. PMID: 36104654 Free PMC article.
Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims : Let's Share the Success Stories to Move the Industry Forward.
Mowlem FD, Tenaerts P, Gwaltney C, Oakley-Girvan I. Mowlem FD, et al. Among authors: tenaerts p. Ther Innov Regul Sci. 2022 Jul;56(4):531-535. doi: 10.1007/s43441-022-00412-1. Epub 2022 May 9. Ther Innov Regul Sci. 2022. PMID: 35534774 Free PMC article.
Digitizing clinical trials.
Inan OT, Tenaerts P, Prindiville SA, Reynolds HR, Dizon DS, Cooper-Arnold K, Turakhia M, Pletcher MJ, Preston KL, Krumholz HM, Marlin BM, Mandl KD, Klasnja P, Spring B, Iturriaga E, Campo R, Desvigne-Nickens P, Rosenberg Y, Steinhubl SR, Califf RM. Inan OT, et al. Among authors: tenaerts p. NPJ Digit Med. 2020 Jul 31;3:101. doi: 10.1038/s41746-020-0302-y. eCollection 2020. NPJ Digit Med. 2020. PMID: 32821856 Free PMC article. Review.
A framework for assessing clinical trial site readiness.
Buse JB, Austin CP, Johnston SC, Lewis-Hall F, March AN, Shore CK, Tenaerts P, Rutter JL. Buse JB, et al. Among authors: tenaerts p. J Clin Transl Sci. 2023 May 8;7(1):e151. doi: 10.1017/cts.2023.541. eCollection 2023. J Clin Transl Sci. 2023. PMID: 37456265 Free PMC article.
Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team.
Donnelly H, Alemayehu D, Botgros R, Comic-Savic S, Eisenstein B, Lorenz B, Merchant K, Pelfrene E, Reith C, Santiago J, Tiernan R, Wunderink R, Tenaerts P, Knirsch C. Donnelly H, et al. Among authors: tenaerts p. Clin Infect Dis. 2016 Aug 15;63 Suppl 2:S39-45. doi: 10.1093/cid/ciw316. Clin Infect Dis. 2016. PMID: 27481952
PROPHETIC: Prospective Identification of Pneumonia in Hospitalized Patients in the ICU.
Bergin SP, Coles A, Calvert SB, Farley J, Powers JH, Zervos MJ, Sims M, Kollef MH, Durkin MJ, Kabchi BA, Donnelly HK, Bardossy AC, Greenshields C, Rubin D, Sun JL, Chiswell K, Santiago J, Gu P, Tenaerts P, Fowler VG Jr, Holland TL. Bergin SP, et al. Among authors: tenaerts p. Chest. 2020 Dec;158(6):2370-2380. doi: 10.1016/j.chest.2020.06.034. Epub 2020 Jun 29. Chest. 2020. PMID: 32615191 Free PMC article.
PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts.
Bergin SP, Calvert SB, Farley J, Sun JL, Chiswell K, Dieperink W, Kluytmans J, Lopez-Delgado JC, Leon-Lopez R, Zervos MJ, Kollef MH, Sims M, Kabchi BA, Rubin D, Santiago J, Natarajan M, Tenaerts P, Fowler VG, Holland TL, Bonten MJ, Hullegie SJ. Bergin SP, et al. Among authors: tenaerts p. Open Forum Infect Dis. 2022 May 9;9(7):ofac231. doi: 10.1093/ofid/ofac231. eCollection 2022 Jul. Open Forum Infect Dis. 2022. PMID: 35836748 Free PMC article.
24 results