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Items: 11


The Value of Addressing Patient Preferences.

Allen JD, Stewart MD, Roberts SA, Sigal EV.

Value Health. 2017 Feb;20(2):283-285. doi: 10.1016/j.jval.2016.11.029.


The 21st Century Cures Act.

McClellan MB, Sigal EV.

N Engl J Med. 2015 Oct 22;373(17):1677-8. doi: 10.1056/NEJMc1509640. No abstract available.


Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.

Herbst RS, Gandara DR, Hirsch FR, Redman MW, LeBlanc M, Mack PC, Schwartz LH, Vokes E, Ramalingam SS, Bradley JD, Sparks D, Zhou Y, Miwa C, Miller VA, Yelensky R, Li Y, Allen JD, Sigal EV, Wholley D, Sigman CC, Blumenthal GM, Malik S, Kelloff GJ, Abrams JS, Blanke CD, Papadimitrakopoulou VA.

Clin Cancer Res. 2015 Apr 1;21(7):1514-24. doi: 10.1158/1078-0432.CCR-13-3473. Epub 2015 Feb 13.


Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.

Fridlyand J, Simon RM, Walrath JC, Roach N, Buller R, Schenkein DP, Flaherty KT, Allen JD, Sigal EV, Scher HI.

Nat Rev Drug Discov. 2013 Oct;12(10):743-55. doi: 10.1038/nrd4101. Epub 2013 Sep 6. Review.


Developing standards for breakthrough therapy designation in oncology.

Horning SJ, Haber DA, Selig WK, Ivy SP, Roberts SA, Allen JD, Sigal EV, Sawyers CL.

Clin Cancer Res. 2013 Aug 15;19(16):4297-304. doi: 10.1158/1078-0432.CCR-13-0523. Epub 2013 May 29.


Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.

Shea MB, Roberts SA, Walrath JC, Allen JD, Sigal EV.

Clin Cancer Res. 2013 Jul 15;19(14):3722-31. doi: 10.1158/1078-0432.CCR-13-0316. Epub 2013 May 10.


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.

Clin Pharmacol Ther. 2012 Mar;91(3):426-37. doi: 10.1038/clpt.2011.345. Epub 2012 Feb 15. Review.


Achieving the goals of effective, safe, and individualized cancer care.

Roberts SA, Karnes EK, Allen JD, Benner JS, Sigal EV, McClellan M.

Clin Cancer Res. 2011 Nov 1;17(21):6632-3. doi: 10.1158/1078-0432.CCR-11-1104. No abstract available.


Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.

Roberts SA, Allen JD, Sigal EV.

Health Aff (Millwood). 2011 Jul;30(7):1375-81. doi: 10.1377/hlthaff.2011.0231. Epub 2011 Jun 16.


Drug safety and drug efficacy: two sides of the same coin.

Young RC, Friedman MA, Schilsky RL, Sigal EV.

Clin Cancer Res. 2007 May 1;13(9):2533-4. No abstract available.


Report from THE MARCH Research Task Force. September 25-26, 1998.

Sigal EV, Barker AD.

Cancer Res. 1998 Dec 1;58(23):5590-627. No abstract available.

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