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"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. Among authors: brown j. 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. Among authors: brown j. 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.
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. Among authors: brown j. 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.
The next frontier: Fostering innovation by improving health data access and utilization.
Oye KA, Jain G, Amador M, Arnaout R, Brown JS, Crown W, Ferguson J, Pezalla E, Rassen JA, Selker HP, Trusheim M, Hirsch G. Oye KA, et al. Among authors: brown js. Clin Pharmacol Ther. 2015 Nov;98(5):514-21. doi: 10.1002/cpt.191. Epub 2015 Sep 10. Clin Pharmacol Ther. 2015. PMID: 26234275 Free PMC article. Review. No abstract available.
Reporting to Improve Reproducibility and Facilitate Validity Assessment for Healthcare Database Studies V1.0.
Wang SV, Schneeweiss S, Berger ML, Brown J, de Vries F, Douglas I, Gagne JJ, Gini R, Klungel O, Mullins CD, Nguyen MD, Rassen JA, Smeeth L, Sturkenboom M; joint ISPE-ISPOR Special Task Force on Real World Evidence in Health Care Decision Making. Wang SV, et al. Among authors: brown j. Pharmacoepidemiol Drug Saf. 2017 Sep;26(9):1018-1032. doi: 10.1002/pds.4295. Pharmacoepidemiol Drug Saf. 2017. PMID: 28913963 Free PMC article.
Sex Differences in Long COVID.
Shah DP, Thaweethai T, Karlson EW, Bonilla H, Horne BD, Mullington JM, Wisnivesky JP, Hornig M, Shinnick DJ, Klein JD, Erdmann NB, Brosnahan SB, Lee-Iannotti JK, Metz TD, Maughan C, Ofotokun I, Reeder HT, Stiles LE, Shaukat A, Hess R, Ashktorab H, Bartram L, Bassett IV, Becker JH, Brim H, Charney AW, Chopra T, Clifton RG, Deeks SG, Erlandson KM, Fierer DS, Flaherman VJ, Fonseca V, Gander JC, Hodder SL, Jacoby VL, Kotini-Shah P, Krishnan JA, Kumar A, Levy BD, Lieberman D, Lin JJ, Martin JN, McComsey GA, Moukabary T, Okumura MJ, Peluso MJ, Rosen CJ, Saade G, Shah PK, Sherif ZA, Taylor BS, Tuttle KR, Urdaneta AE, Wallick JA, Wiley Z, Zhang D, Horwitz LI, Foulkes AS, Singer NG; RECOVER Consortium. Shah DP, et al. JAMA Netw Open. 2025 Jan 2;8(1):e2455430. doi: 10.1001/jamanetworkopen.2024.55430. JAMA Netw Open. 2025. PMID: 39841477
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