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Items: 1 to 20 of 111

1.

Adaptive designs for confirmatory clinical trials with subgroup selection.

Stallard N, Hamborg T, Parsons N, Friede T.

J Biopharm Stat. 2014;24(1):168-87. doi: 10.1080/10543406.2013.857238. Review.

PMID:
24392984
2.

On sample size determination in multi-armed confirmatory adaptive designs.

Wassmer G.

J Biopharm Stat. 2011 Jul;21(4):802-17. doi: 10.1080/10543406.2011.551336.

PMID:
21516570
3.

Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program.

Wang SJ, Hung HM, O'Neill R.

J Biopharm Stat. 2011 Jul;21(4):846-59. doi: 10.1080/10543406.2011.552878.

PMID:
21516573
4.

Designing Issues in Confirmatory Adaptive Population Enrichment Trials.

Wassmer G, Dragalin V.

J Biopharm Stat. 2015;25(4):651-69. doi: 10.1080/10543406.2014.920869.

PMID:
24905739
5.
6.
7.

Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls.

Bauer P, Bretz F, Dragalin V, König F, Wassmer G.

Stat Med. 2016 Feb 10;35(3):325-47. doi: 10.1002/sim.6472. Epub 2015 Mar 16.

PMID:
25778935
8.

Adaptive methods: when and how should they be used in clinical trials?

Porcher R, Lecocq B, Vray M; participants of Round Table N° 2 de Giens XXVI.

Therapie. 2011 Jul-Aug;66(4):319-26, 309-17. doi: 10.2515/therapie/2011042. Epub 2011 Aug 19. English, French.

9.

A consultant's perspective on the regulatory hurdles to adaptive trials.

Mehta CR, Jemiai Y.

Biom J. 2006 Aug;48(4):604-8; discussion 613-22.

PMID:
16972712
10.

A simple and flexible graphical approach for adaptive group-sequential clinical trials.

Sugitani T, Bretz F, Maurer W.

J Biopharm Stat. 2016;26(2):202-16. doi: 10.1080/10543406.2014.972509. Epub 2014 Nov 5.

11.

A Bayesian predictive sample size selection design for single-arm exploratory clinical trials.

Teramukai S, Daimon T, Zohar S.

Stat Med. 2012 Dec 30;31(30):4243-54. doi: 10.1002/sim.5505. Epub 2012 Jul 16.

PMID:
22807115
12.

Adaptive methods: telling "the rest of the story".

Emerson SS, Fleming TR.

J Biopharm Stat. 2010 Nov;20(6):1150-65. doi: 10.1080/10543406.2010.514457.

PMID:
21058111
13.

Survival endpoints and adaptive designs.

Bauer P.

Biom J. 2006 Aug;48(4):730-1.

PMID:
16972725
14.

A conditional error function approach for subgroup selection in adaptive clinical trials.

Friede T, Parsons N, Stallard N.

Stat Med. 2012 Dec 30;31(30):4309-20. doi: 10.1002/sim.5541. Epub 2012 Aug 3. Erratum in: Stat Med. 2013 Jun 30;32(14):2513-4.

PMID:
22865774
15.

A novel adaptive design strategy increases the efficiency of clinical trials in secondary progressive multiple sclerosis.

Chataway J, Nicholas R, Todd S, Miller DH, Parsons N, Valdés-Márquez E, Stallard N, Friede T.

Mult Scler. 2011 Jan;17(1):81-8. doi: 10.1177/1352458510382129. Epub 2010 Aug 26.

PMID:
20798135
16.

Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit.

Royston P, Barthel FM, Parmar MK, Choodari-Oskooei B, Isham V.

Trials. 2011 Mar 18;12:81. doi: 10.1186/1745-6215-12-81.

17.

Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review.

Ondra T, Dmitrienko A, Friede T, Graf A, Miller F, Stallard N, Posch M.

J Biopharm Stat. 2016;26(1):99-119. doi: 10.1080/10543406.2015.1092034. Review.

18.

Improving Probabilities of Correct Interim Decision in Population Enrichment Designs.

Götte H, Donica M, Mordenti G.

J Biopharm Stat. 2015;25(5):1020-38. doi: 10.1080/10543406.2014.929583. Epub 2014 Jun 10.

PMID:
24914474
19.

Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome.

Choodari-Oskooei B, Parmar MK, Royston P, Bowden J.

Trials. 2013 Jan 23;14:23. doi: 10.1186/1745-6215-14-23.

20.

Some Issues of Sample Size Calculation for Time-to-Event Endpoints Using the Freedman and Schoenfeld Formulas.

Abel UR, Jensen K, Karapanagiotou-Schenkel I, Kieser M.

J Biopharm Stat. 2015;25(6):1285-311. doi: 10.1080/10543406.2014.1000546. Epub 2015 Jan 28.

PMID:
25629760

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