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A Useful and Sustainable Role for N-of-1 Trials in the Healthcare Ecosystem.
Selker HP, Cohen T, D'Agostino RB, Dere WH, Ghaemi SN, Honig PK, Kaitin KI, Kaplan HC, Kravitz RL, Larholt K, McElwee NE, Oye KA, Palm ME, Perfetto E, Ramanathan C, Schmid CH, Seyfert-Margolis V, Trusheim M, Eichler HG. Selker HP, et al. Among authors: honig pk. Clin Pharmacol Ther. 2022 Aug;112(2):224-232. doi: 10.1002/cpt.2425. Epub 2021 Oct 20. Clin Pharmacol Ther. 2022. PMID: 34551122 Free PMC article. Review.
Efficacy and Effectiveness Too Trials: Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide Practice.
Selker HP, Eichler HG, Stockbridge NL, McElwee NE, Dere WH, Cohen T, Erban JK, Seyfert-Margolis VL, Honig PK, Kaitin KI, Oye KA, D'Agostino RB Sr. Selker HP, et al. Among authors: honig pk. Clin Pharmacol Ther. 2019 Apr;105(4):857-866. doi: 10.1002/cpt.1347. Epub 2019 Feb 12. Clin Pharmacol Ther. 2019. PMID: 30610746 Free PMC article.
A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials.
Selker HP, Oye KA, Eichler HG, Stockbridge NL, Mehta CR, Kaitin KI, McElwee NE, Honig PK, Erban JK, D'Agostino RB. Selker HP, et al. Among authors: honig pk. Clin Pharmacol Ther. 2014 Feb;95(2):147-53. doi: 10.1038/clpt.2013.177. Epub 2013 Sep 23. Clin Pharmacol Ther. 2014. PMID: 24060819 Free PMC article.
"Threshold-crossing": A Useful Way to Establish the Counterfactual in Clinical Trials?
Eichler HG, Bloechl-Daum B, Bauer P, Bretz F, Brown J, Hampson LV, Honig P, Krams M, Leufkens H, Lim R, Lumpkin MM, Murphy MJ, Pignatti F, Posch M, Schneeweiss S, Trusheim M, Koenig F. Eichler HG, et al. Clin Pharmacol Ther. 2016 Dec;100(6):699-712. doi: 10.1002/cpt.515. Epub 2016 Oct 19. Clin Pharmacol Ther. 2016. PMID: 27650716 Free PMC article.
Adaptive licensing: taking the next step in the evolution of drug approval.
Eichler HG, Oye K, Baird LG, Abadie E, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JC, Lim R, Lumpkin MM, Neil G, O'Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF, Hirsch G. Eichler HG, et al. Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Clin Pharmacol Ther. 2012. PMID: 22336591 Review.
Reinventing bioinnovation.
Kaitin KI, Honig PK. Kaitin KI, et al. Among authors: honig pk. Clin Pharmacol Ther. 2013 Sep;94(3):279-83. doi: 10.1038/clpt.2013.129. Clin Pharmacol Ther. 2013. PMID: 23963211
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
Adaptive Biomedical Innovation.
Honig PK, Hirsch G. Honig PK, et al. Clin Pharmacol Ther. 2016 Dec;100(6):574-578. doi: 10.1002/cpt.513. Clin Pharmacol Ther. 2016. PMID: 27859144
67 results