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Real World Data in Adaptive Biomedical Innovation: A Framework for Generating Evidence Fit for Decision-Making.
Schneeweiss S, Eichler HG, Garcia-Altes A, Chinn C, Eggimann AV, Garner S, Goettsch W, Lim R, Löbker W, Martin D, Müller T, Park BJ, Platt R, Priddy S, Ruhl M, Spooner A, Vannieuwenhuyse B, Willke RJ. Schneeweiss S, et al. Among authors: garner s. Clin Pharmacol Ther. 2016 Dec;100(6):633-646. doi: 10.1002/cpt.512. Epub 2016 Oct 19. Clin Pharmacol Ther. 2016. PMID: 27627027
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: garner s. 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: garner s. 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.
Corrigendum: Adaptive biomedical innovation: Evolving our global system to sustainably and safely bring new medicines to patients in need.
Hirsch G, Trusheim M, Cobbs E, Bala M, Garner S, Hartman D, Isaacs K, Lumpkin M, Lim R, Oye K, Pezalla E, Saltonstall P, Selker H. Hirsch G, et al. Among authors: garner s. Clin Pharmacol Ther. 2017 Apr;101(4):542. doi: 10.1002/cpt.643. Clin Pharmacol Ther. 2017. PMID: 28318021 Free PMC article. No abstract available.
10 years of NICE: still growing and still controversial.
Littlejohns P, Garner S, Doyle N, Macbeth F, Barnett D, Longson C. Littlejohns P, et al. Among authors: garner s. Lancet Oncol. 2009 Apr;10(4):417-24. doi: 10.1016/S1470-2045(09)70077-4. Lancet Oncol. 2009. PMID: 19341973 Review.
Evidence informed decision making: the use of "colloquial evidence" at nice.
Sharma T, Choudhury M, Kaur B, Naidoo B, Garner S, Littlejohns P, Staniszewska S. Sharma T, et al. Among authors: garner s. Int J Technol Assess Health Care. 2015 Jan;31(3):138-46. doi: 10.1017/S0266462314000749. Epub 2015 May 20. Int J Technol Assess Health Care. 2015. PMID: 25991028
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