Geiger MJ - Search Results

1

Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.

Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Spencer K, et al. Among authors: geiger mj. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608. J Diabetes Sci Technol. 2012. PMID: 23294774 Free PMC article. Clinical Trial.

2

Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5).

Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Skrivanek Z, et al. Among authors: geiger mj. Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22. Diabetes Obes Metab. 2014. PMID: 24762094 Free article. Clinical Trial.

3

Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations.

Skrivanek Z, Berry S, Berry D, Chien J, Geiger MJ, Anderson JH, Gaydos B. Skrivanek Z, et al. Among authors: geiger mj. J Diabetes Sci Technol. 2012 Nov 1;6(6):1305-18. doi: 10.1177/193229681200600609. J Diabetes Sci Technol. 2012. PMID: 23294775 Free PMC article. Clinical Trial.

4

An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics.

Geiger MJ, Skrivanek Z, Gaydos B, Chien J, Berry S, Berry D. Geiger MJ, et al. J Diabetes Sci Technol. 2012 Nov 1;6(6):1319-27. doi: 10.1177/193229681200600610. J Diabetes Sci Technol. 2012. PMID: 23294776 Free PMC article. Clinical Trial.

5

Clinical Development Approaches and Statistical Methodologies to Prospectively Assess the Cardiovascular Risk of New Antidiabetic Therapies for Type 2 Diabetes.

Geiger MJ, Mehta C, Turner JR, Arbet-Engels C, Hantel S, Hirshberg B, Koglin J, Mendzelevski B, Sager PT, Shapiro D, Stewart M, Todaro TG, Gaydos B. Geiger MJ, et al. Ther Innov Regul Sci. 2015 Jan;49(1):50-64. doi: 10.1177/2168479014549860. Ther Innov Regul Sci. 2015. PMID: 30222452

6

Effects of the once-weekly glucagon-like peptide-1 receptor agonist dulaglutide on ambulatory blood pressure and heart rate in patients with type 2 diabetes mellitus.

Ferdinand KC, White WB, Calhoun DA, Lonn EM, Sager PT, Brunelle R, Jiang HH, Threlkeld RJ, Robertson KE, Geiger MJ. Ferdinand KC, et al. Among authors: geiger mj. Hypertension. 2014 Oct;64(4):731-7. doi: 10.1161/HYPERTENSIONAHA.114.03062. Epub 2014 Jun 30. Hypertension. 2014. PMID: 24980665 Clinical Trial.

7

Restricted mean survival time for the analysis of cardiovascular outcome trials assessing non-inferiority: Case studies from antihyperglycemic drug development.

Manner DH, Battioui C, Hantel S, Beasley BN, Wei LJ, Geiger MJ, Turner JR, Abt M. Manner DH, et al. Among authors: geiger mj. Am Heart J. 2019 Sep;215:178-186. doi: 10.1016/j.ahj.2019.05.016. Epub 2019 Jun 6. Am Heart J. 2019. PMID: 31349109 Review.

8

Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharmacologic trials: a report from the Cardiac Safety Research Consortium.

Seltzer JH, Turner JR, Geiger MJ, Rosano G, Mahaffey KW, White WB, Sabol MB, Stockbridge N, Sager PT. Seltzer JH, et al. Among authors: geiger mj. Am Heart J. 2015 Feb;169(2):197-204. doi: 10.1016/j.ahj.2014.11.003. Epub 2014 Nov 10. Am Heart J. 2015. PMID: 25641528

9

Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.

Sager P, Heilbraun J, Turner JR, Gintant G, Geiger MJ, Kowey PR, Mansoor GA, Mendzelevski B, Michelson EL, Stockbridge N, Weber MA, White WB. Sager P, et al. Among authors: geiger mj. Am Heart J. 2013 Apr;165(4):477-88. doi: 10.1016/j.ahj.2013.01.002. Epub 2013 Feb 4. Am Heart J. 2013. PMID: 23537963

10

The evaluation and management of drug effects on cardiac conduction (PR and QRS intervals) in clinical development.

Nada A, Gintant GA, Kleiman R, Gutstein DE, Gottfridsson C, Michelson EL, Strnadova C, Killeen M, Geiger MJ, Fiszman ML, Koplowitz LP, Carlson GF, Rodriguez I, Sager PT. Nada A, et al. Among authors: geiger mj. Am Heart J. 2013 Apr;165(4):489-500. doi: 10.1016/j.ahj.2013.01.011. Epub 2013 Feb 21. Am Heart J. 2013. PMID: 23537964 Review.

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