-
2
-
-
33748560823
-
Plan to be flexible: a commentary on adaptive designs
-
Shih WJ. Plan to be flexible: a commentary on adaptive designs. Biometrical J. 2006; 48:656-9.
-
(2006)
Biometrical J
, vol.48
, pp. 656-659
-
-
Shih, W.J.1
-
3
-
-
85042556950
-
What is adaptive design?
-
Accessed 7 Jul 2017.
-
Berry Consultants. What is adaptive design? 2016. http://www.berryconsultants.com/adaptive-designs. Accessed 7 Jul 2017.
-
(2016)
-
-
-
4
-
-
84889662412
-
Similarities and differences of Bayesian designs and adaptive designs for medical devices: a regulatory view
-
Campbell G. Similarities and differences of Bayesian designs and adaptive designs for medical devices: a regulatory view. Stat Biopharm Res. 2013; 5:356-68.
-
(2013)
Stat Biopharm Res
, vol.5
, pp. 356-368
-
-
Campbell, G.1
-
6
-
-
0348149055
-
Sample size re-estimation in group-sequential response-adaptive clinical trials
-
Morgan CC. Sample size re-estimation in group-sequential response-adaptive clinical trials. Stat Med. 2003; 22:3843-57.
-
(2003)
Stat Med
, vol.22
, pp. 3843-3857
-
-
Morgan, C.C.1
-
7
-
-
51749123391
-
Speeding up the evaluation of new agents in cancer
-
Parmar MKB, Barthel FMS, Sydes M, Langley R, Kaplan R, Eisenhauer E, et al.Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst. 2008; 100:1204-14.
-
(2008)
J Natl Cancer Inst
, vol.100
, pp. 1204-1214
-
-
Parmar, M.K.B.1
Barthel, F.M.S.2
Sydes, M.3
Langley, R.4
Kaplan, R.5
Eisenhauer, E.6
-
8
-
-
36248945137
-
Recent developments in adaptive designs for phase I/II dose-finding studies
-
Zohar S, Chevret S. Recent developments in adaptive designs for phase I/II dose-finding studies. J Biopharm Stat. 2007; 17:1071-83.
-
(2007)
J Biopharm Stat
, vol.17
, pp. 1071-1083
-
-
Zohar, S.1
Chevret, S.2
-
9
-
-
84910057278
-
Novel statistical designs for phase I/II and phase II clinical trials with dose-finding objectives
-
Sverdlov O, Wong WK. Novel statistical designs for phase I/II and phase II clinical trials with dose-finding objectives. Ther Innov Regul Sci. 2014; 48:601-12.
-
(2014)
Ther Innov Regul Sci
, vol.48
, pp. 601-612
-
-
Sverdlov, O.1
Wong, W.K.2
-
10
-
-
33750854113
-
Adaptive seamless phase II/III designs-background, operational aspects, and examples
-
Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. Adaptive seamless phase II/III designs-background, operational aspects, and examples. Drug Inf J. 2006; 40:463-73.
-
(2006)
Drug Inf J
, vol.40
, pp. 463-473
-
-
Maca, J.1
Bhattacharya, S.2
Dragalin, V.3
Gallo, P.4
Krams, M.5
-
12
-
-
22044434097
-
Statistical consideration of adaptive methods in clinical development
-
Chow SC, Chang M, Pong A. Statistical consideration of adaptive methods in clinical development. J Biopharm Stat. 2005; 15:575-91.
-
(2005)
J Biopharm Stat
, vol.15
, pp. 575-591
-
-
Chow, S.C.1
Chang, M.2
Pong, A.3
-
13
-
-
43649105816
-
Maintaining confidentiality of interim data to enhance trial integrity and credibility
-
Fleming TR, Sharples K, McCall J, Moore A, Rodgers A, Stewart R. Maintaining confidentiality of interim data to enhance trial integrity and credibility. Clin Trials. 2008; 5:157-67.
-
(2008)
Clin Trials
, vol.5
, pp. 157-167
-
-
Fleming, T.R.1
Sharples, K.2
McCall, J.3
Moore, A.4
Rodgers, A.5
Stewart, R.6
-
15
-
-
78249253755
-
Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim
-
Posch M, Maurer W, Bretz F. Type I error rate control in adaptive designs for confirmatory clinical trials with treatment selection at interim. Pharm Stat. 2011; 10:96-104.
-
(2011)
Pharm Stat
, vol.10
, pp. 96-104
-
-
Posch, M.1
Maurer, W.2
Bretz, F.3
-
16
-
-
79957950338
-
Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre-planned interim look
-
Graf AC, Bauer P. Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre-planned interim look. Stat Med. 2011; 30:1637-47.
-
(2011)
Stat Med
, vol.30
, pp. 1637-1647
-
-
Graf, A.C.1
Bauer, P.2
-
17
-
-
84903637900
-
Maximum type 1 error rate inflation in multiarmed clinical trials with adaptive interim sample size modifications
-
Graf AC, Bauer P, Glimm E, Koenig F. Maximum type 1 error rate inflation in multiarmed clinical trials with adaptive interim sample size modifications. Biometrical J. 2014; 56:614-30.
-
(2014)
Biometrical J
, vol.56
, pp. 614-630
-
-
Graf, A.C.1
Bauer, P.2
Glimm, E.3
Koenig, F.4
-
18
-
-
84890421989
-
Simultaneous confidence intervals that are compatible with closed testing in adaptive designs
-
Magirr D, Jaki T, Posch M, Klinglmueller F. Simultaneous confidence intervals that are compatible with closed testing in adaptive designs. Biometrika. 2013; 100:985-96.
-
(2013)
Biometrika
, vol.100
, pp. 985-996
-
-
Magirr, D.1
Jaki, T.2
Posch, M.3
Klinglmueller, F.4
-
19
-
-
84891382810
-
A comparison of methods for constructing confidence intervals after phase II/III clinical trials
-
Kimani PK, Todd S, Stallard N. A comparison of methods for constructing confidence intervals after phase II/III clinical trials. Biometrical J. 2014; 56:107-28.
-
(2014)
Biometrical J
, vol.56
, pp. 107-128
-
-
Kimani, P.K.1
Todd, S.2
Stallard, N.3
-
20
-
-
84864278404
-
The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings
-
Lorch U, Berelowitz K, Ozen C, Naseem A, Akuffo E, Taubel J. The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings. Eur J Clin Pharmacol. 2012; 68:543-51.
-
(2012)
Eur J Clin Pharmacol
, vol.68
, pp. 543-551
-
-
Lorch, U.1
Berelowitz, K.2
Ozen, C.3
Naseem, A.4
Akuffo, E.5
Taubel, J.6
-
21
-
-
84954167098
-
Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls
-
Bauer P, Bretz F, Dragalin V, König F, Wassmer G. Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls. Stat Med. 2016; 35:325-47.
-
(2016)
Stat Med
, vol.35
, pp. 325-347
-
-
Bauer, P.1
Bretz, F.2
Dragalin, V.3
König, F.4
Wassmer, G.5
-
22
-
-
66849118694
-
Dose escalation methods in phase I cancer clinical trials
-
Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009; 101:708-20.
-
(2009)
J Natl Cancer Inst
, vol.101
, pp. 708-720
-
-
Lee, J.J.1
Siu, L.L.2
-
23
-
-
84861200623
-
Bayesian adaptive clinical trials: a dream for statisticians only?
-
Chevret S. Bayesian adaptive clinical trials: a dream for statisticians only?Stat Med. 2012; 31:1002-13.
-
(2012)
Stat Med
, vol.31
, pp. 1002-1013
-
-
Chevret, S.1
-
24
-
-
84876557281
-
Uptake of novel statistical methods for early-phase clinical studies in the UK public sector
-
Jaki T. Uptake of novel statistical methods for early-phase clinical studies in the UK public sector. Clin Trials. 2013; 10:344-6.
-
(2013)
Clin Trials
, vol.10
, pp. 344-346
-
-
Jaki, T.1
-
25
-
-
84903529904
-
Adaptive design: results of 2012 survey on perception and use
-
Morgan CC, Huyck S, Jenkins M, Chen L, Bedding A, Coffey CS, et al.Adaptive design: results of 2012 survey on perception and use. Ther Innov Regul Sci. 2014; 48:473-81.
-
(2014)
Ther Innov Regul Sci
, vol.48
, pp. 473-481
-
-
Morgan, C.C.1
Huyck, S.2
Jenkins, M.3
Chen, L.4
Bedding, A.5
Coffey, C.S.6
-
26
-
-
84942308496
-
Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials
-
Dimairo M, Boote J, Julious SA, Nicholl JP, Todd S. Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials. Trials. 2015; 16:430.
-
(2015)
Trials
, vol.16
, pp. 430
-
-
Dimairo, M.1
Boote, J.2
Julious, S.A.3
Nicholl, J.P.4
Todd, S.5
-
27
-
-
84951808541
-
Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials
-
Dimairo M, Julious SA, Todd S, Nicholl JP, Boote J. Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials. Trials. 2015; 16:585.
-
(2015)
Trials
, vol.16
, pp. 585
-
-
Dimairo, M.1
Julious, S.A.2
Todd, S.3
Nicholl, J.P.4
Boote, J.5
-
28
-
-
84961201800
-
Adaptive designs undertaken in clinical research: a review of registered clinical trials
-
Hatfield I, Allison A, Flight L, Julious SA, Dimairo M. Adaptive designs undertaken in clinical research: a review of registered clinical trials. Trials. 2016; 17:150.
-
(2016)
Trials
, vol.17
, pp. 150
-
-
Hatfield, I.1
Allison, A.2
Flight, L.3
Julious, S.A.4
Dimairo, M.5
-
29
-
-
84979680959
-
Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project
-
Meurer WJ, Legocki L, Mawocha S, Frederiksen SM, Guetterman TC, Barsan W, et al.Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project. Trials. 2016; 17:373.
-
(2016)
Trials
, vol.17
, pp. 373
-
-
Meurer, W.J.1
Legocki, L.2
Mawocha, S.3
Frederiksen, S.M.4
Guetterman, T.C.5
Barsan, W.6
-
30
-
-
0348129532
-
Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial
-
Chaitman BR, Pepine CJ, Parker JO, Skopal J, Chumakova G, Kuch J, et al.Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina: a randomized controlled trial. J Am Med Assoc. 2004; 291:309-16.
-
(2004)
J Am Med Assoc
, vol.291
, pp. 309-316
-
-
Chaitman, B.R.1
Pepine, C.J.2
Parker, J.O.3
Skopal, J.4
Chumakova, G.5
Kuch, J.6
-
31
-
-
84945584299
-
Telmisartan and insulin resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy
-
Pushpakom SP, Taylor C, Kolamunnage-Dona R, Spowart C, Vora J, García-Fiñana M, et al. Telmisartan and insulin resistance in HIV (TAILoR): protocol for a dose-ranging phase II randomised open-labelled trial of telmisartan as a strategy for the reduction of insulin resistance in HIV-positive individuals on combination antiretroviral therapy. BMJ Open. 2015; 5:e009566.
-
(2015)
BMJ Open
, vol.5
-
-
Pushpakom, S.P.1
Taylor, C.2
Kolamunnage-Dona, R.3
Spowart, C.4
García-Fiñana, M.5
-
32
-
-
84861646016
-
A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection
-
Magirr D, Jaki T, Whitehead J. A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection. Biometrika. 2012; 99:494-501.
-
(2012)
Biometrika
, vol.99
, pp. 494-501
-
-
Magirr, D.1
Jaki, T.2
Whitehead, J.3
-
33
-
-
0038811777
-
Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia
-
Giles FJ, Kantarjian HM, Cortes JE, Garcia-Manero G, Verstovsek S, Faderl S, et al.Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia. J Clin Oncol. 2003; 21:1722-7.
-
(2003)
J Clin Oncol
, vol.21
, pp. 1722-1727
-
-
Giles, F.J.1
Kantarjian, H.M.2
Cortes, J.E.3
Garcia-Manero, G.4
Verstovsek, S.5
Faderl, S.6
-
34
-
-
82055200248
-
Adaptive increase in sample size when interim results are promising: a practical guide with examples
-
Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med. 2011; 30:3267-84.
-
(2011)
Stat Med
, vol.30
, pp. 3267-3284
-
-
Mehta, C.R.1
Pocock, S.J.2
-
35
-
-
84945978676
-
Adaptive sample size modification in clinical trials: start small then ask for more?
-
Jennison C, Turnbull BW. Adaptive sample size modification in clinical trials: start small then ask for more?Stat Med. 2015; 34:3793-810.
-
(2015)
Stat Med
, vol.34
, pp. 3793-3810
-
-
Jennison, C.1
Turnbull, B.W.2
-
36
-
-
84891827000
-
Empirical Bayes estimation of the selected treatment mean for two-stage drop-the-loser trials: a meta-analytic approach
-
Bowden J, Brannath W, Glimm E. Empirical Bayes estimation of the selected treatment mean for two-stage drop-the-loser trials: a meta-analytic approach. Stat Med. 2014; 33:388-400.
-
(2014)
Stat Med
, vol.33
, pp. 388-400
-
-
Bowden, J.1
Brannath, W.2
Glimm, E.3
-
37
-
-
85006010367
-
Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment
-
Mason AJ, Gonzalez-Maffe J, Quinn K, Doyle N, Legg K, Norsworthy P, et al.Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment. Stat Med. 2017; 36:754-71.
-
(2017)
Stat Med
, vol.36
, pp. 754-771
-
-
Mason, A.J.1
Gonzalez-Maffe, J.2
Quinn, K.3
Doyle, N.4
Legg, K.5
Norsworthy, P.6
-
38
-
-
85042561918
-
-
Accessed 7 Jul 2017.
-
Wellcome Trust. Joint Global Health Trials scheme. 2017. https://wellcome.ac.uk/funding/joint-global-health-trials-scheme. Accessed 7 Jul 2017.
-
(2017)
Joint Global Health Trials scheme
-
-
-
39
-
-
85042556617
-
-
Accessed 7 Jul 2017.
-
National Institutes of Health. NIH Planning Grant Program (R34). 2014. https://grants.nih.gov/grants/funding/r34.htm. Accessed 7 Jul 2017.
-
(2014)
NIH Planning Grant Program (R34)
-
-
-
40
-
-
70449645866
-
Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design
-
Accessed 7 Jul 2017.
-
European Medicines Agency. Reflection paper on methodological issues in confirmatory clinical trials planned with an adaptive design. 2007. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003616.pdf. Accessed 7 Jul 2017.
-
(2007)
-
-
-
41
-
-
78249234519
-
Adaptive design clinical trials for drugs and biologics: guidance for industry (draft)
-
Accessed 7 Jul 2017.
-
US Food & Drug Administration. Adaptive design clinical trials for drugs and biologics: guidance for industry (draft). 2010. https://www.fda.gov/downloads/drugs/guidances/ucm201790.pdf. Accessed 7 Jul 2017.
-
(2010)
-
-
-
42
-
-
85021428107
-
Adaptive designs for medical device clinical studies: guidance for industry and Food and Drug Administration staff
-
Accessed 7 Jul 2017.
-
Food US & Drug Administration. Adaptive designs for medical device clinical studies: guidance for industry and Food and Drug Administration staff.2016. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm446729.pdf. Accessed 7 Jul 2017.
-
(2016)
-
-
-
43
-
-
84891486765
-
Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance-where are we now?
-
Gaydos B, Koch A, Miller F, Posch M, Vandemeulebroecke M, Wang SJ. Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance-where are we now?Clin Investig. 2012; 2:235-40.
-
(2012)
Clin Investig
, vol.2
, pp. 235-240
-
-
Gaydos, B.1
Koch, A.2
Miller, F.3
Posch, M.4
Vandemeulebroecke, M.5
Wang, S.J.6
-
44
-
-
84907946289
-
Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
-
Elsäßer A, Regnstrom J, Vetter T, Koenig F, Hemmings RJ, Greco M, et al.Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency. Trials. 2014; 15:383.
-
(2014)
Trials
, vol.15
, pp. 383
-
-
Elsäßer, A.1
Regnstrom, J.2
Vetter, T.3
Koenig, F.4
Hemmings, R.J.5
Greco, M.6
-
45
-
-
2442667708
-
The independent statistician for data monitoring committees
-
DeMets DL, Fleming TR. The independent statistician for data monitoring committees. Stat Med. 2004; 23:1513-17.
-
(2004)
Stat Med
, vol.23
, pp. 1513-1517
-
-
DeMets, D.L.1
Fleming, T.R.2
-
46
-
-
33745175516
-
Operational challenges in adaptive design implementation
-
Gallo P. Operational challenges in adaptive design implementation. Pharm Stat. 2006; 5:119-24.
-
(2006)
Pharm Stat
, vol.5
, pp. 119-124
-
-
Gallo, P.1
-
47
-
-
13844318810
-
A proposed charter for clinical trial data monitoring committees: helping them to do their job well
-
Grant AM, Altman DG, Babiker AG, Campbell MK, Clemens F, Darbyshire JH, et al.A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005; 365:711-22.
-
(2005)
Lancet
, vol.365
, pp. 711-722
-
-
Grant, A.M.1
Altman, D.G.2
Babiker, A.G.3
Campbell, M.K.4
Clemens, F.5
Darbyshire, J.H.6
-
48
-
-
84879519364
-
Views on emerging issues pertaining to data monitoring committees for adaptive trials
-
Antonijevic Z, Gallo P, Chuang-Stein C, Dragalin V, Loewy J, Menon S, et al.Views on emerging issues pertaining to data monitoring committees for adaptive trials. Ther Innov Regul Sci. 2013; 47:495-502.
-
(2013)
Ther Innov Regul Sci
, vol.47
, pp. 495-502
-
-
Antonijevic, Z.1
Gallo, P.2
Chuang-Stein, C.3
Dragalin, V.4
Loewy, J.5
Menon, S.6
-
49
-
-
84905101394
-
A practical guide to data monitoring committees in adaptive trials
-
Sanchez-Kam M, Gallo P, Loewy J, Menon S, Antonijevic Z, Christensen J, et al.A practical guide to data monitoring committees in adaptive trials. Ther Innov Regul Sci. 2014; 48:316-26.
-
(2014)
Ther Innov Regul Sci
, vol.48
, pp. 316-326
-
-
Sanchez-Kam, M.1
Gallo, P.2
Loewy, J.3
Menon, S.4
Antonijevic, Z.5
Christensen, J.6
-
50
-
-
84990043625
-
Data monitoring committees-expect the unexpected
-
DeMets DL, Ellenberg SS. Data monitoring committees-expect the unexpected. N Engl J Med. 2016; 375:1365-71.
-
(2016)
N Engl J Med
, vol.375
, pp. 1365-1371
-
-
DeMets, D.L.1
Ellenberg, S.S.2
-
51
-
-
85026442641
-
Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
-
Calis KA, Archdeacon P, Bain R, DeMets D, Donohue M, Elzarrad MK, et al.Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative. Clin Trials. 2017; 14:342-8.
-
(2017)
Clin Trials
, vol.14
, pp. 342-348
-
-
Calis, K.A.1
Archdeacon, P.2
Bain, R.3
DeMets, D.4
Donohue, M.5
Elzarrad, M.K.6
-
52
-
-
84947076569
-
Trial steering committees in randomised controlled trials: a survey of registered clinical trials units to establish current practice and experiences
-
Conroy EJ, Harman NL, Lane JA, Lewis SC, Murray G, Norrie J, et al.Trial steering committees in randomised controlled trials: a survey of registered clinical trials units to establish current practice and experiences. Clin Trials. 2015; 12:664-76.
-
(2015)
Clin Trials
, vol.12
, pp. 664-676
-
-
Conroy, E.J.1
Harman, N.L.2
Lane, J.A.3
Lewis, S.C.4
Murray, G.5
Norrie, J.6
-
53
-
-
84953379166
-
Exploring the role and function of trial steering committees: results of an expert panel meeting
-
Harman NL, Conroy EJ, Lewis SC, Murray G, Norrie J, Sydes MR, et al.Exploring the role and function of trial steering committees: results of an expert panel meeting. Trials. 2015; 16:597.
-
(2015)
Trials
, vol.16
, pp. 597
-
-
Harman, N.L.1
Conroy, E.J.2
Lewis, S.C.3
Murray, G.4
Norrie, J.5
Sydes, M.R.6
-
54
-
-
84977073551
-
What are the roles and valued attributes of a trial steering committee? Ethnographic study of eight clinical trials facing challenges
-
Daykin A, Selman LE, Cramer H, McCann S, Shorter GW, Sydes MR, et al.What are the roles and valued attributes of a trial steering committee? Ethnographic study of eight clinical trials facing challenges. Trials. 2016; 17:307.
-
(2016)
Trials
, vol.17
, pp. 307
-
-
Daykin, A.1
Selman, L.E.2
Cramer, H.3
McCann, S.4
Shorter, G.W.5
Sydes, M.R.6
-
55
-
-
85009444691
-
Addressing challenges and opportunities of 'less well-understood' adaptive designs
-
He W, Gallo P, Miller E, Jemiai Y, Maca J, Koury K, et al.Addressing challenges and opportunities of 'less well-understood' adaptive designs. Ther Innov Regul Sci. 2017; 51:60-8.
-
(2017)
Ther Innov Regul Sci
, vol.51
, pp. 60-68
-
-
He, W.1
Gallo, P.2
Miller, E.3
Jemiai, Y.4
Maca, J.5
Koury, K.6
-
56
-
-
79960950486
-
Group sequential methods and software applications
-
Zhu L, Ni L, Yao B. Group sequential methods and software applications. Am Stat. 2011; 65:127-35.
-
(2011)
Am Stat
, vol.65
, pp. 127-135
-
-
Zhu, L.1
Ni, L.2
Yao, B.3
-
57
-
-
84954366072
-
A review of available software and capabilities for adaptive designs
-
In: He W, Pinheiro J, Kuznetsova OM, editors. Practical considerations for adaptive trial design and implementation. New York: Springer
-
Tymofyeyev Y. A review of available software and capabilities for adaptive designs In: He W, Pinheiro J, Kuznetsova OM, editors. Practical considerations for adaptive trial design and implementation. New York: Springer: 2014. p. 139-55.
-
(2014)
, pp. 139-155
-
-
Tymofyeyev, Y.1
-
58
-
-
33646245937
-
Adaptive designs in clinical drug development-an executive summary of the PhRMA Working Group
-
Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Adaptive designs in clinical drug development-an executive summary of the PhRMA Working Group. J Biopharm Stat. 2006; 16:275-83.
-
(2006)
J Biopharm Stat
, vol.16
, pp. 275-283
-
-
Gallo, P.1
Chuang-Stein, C.2
Dragalin, V.3
Gaydos, B.4
Krams, M.5
Pinheiro, J.6
-
59
-
-
33750893179
-
Implementing adaptive designs: logistical and operational considerations
-
Quinlan J, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Inf J. 2006; 40:437-44.
-
(2006)
Drug Inf J
, vol.40
, pp. 437-444
-
-
Quinlan, J.1
Krams, M.2
-
60
-
-
44949171503
-
Adaptive design methods in clinical trials-a review
-
Chow SC, Chang M. Adaptive design methods in clinical trials-a review. Orphanet J Rare Dis. 2008; 3:11.
-
(2008)
Orphanet J Rare Dis
, vol.3
, pp. 11
-
-
Chow, S.C.1
Chang, M.2
-
61
-
-
65649093620
-
Adaptive designs for confirmatory clinical trials
-
Bretz F, Koenig F, Brannath W, Glimm E, Posch M. Adaptive designs for confirmatory clinical trials. Stat Med. 2009; 28:1181-217.
-
(2009)
Stat Med
, vol.28
, pp. 1181-1217
-
-
Bretz, F.1
Koenig, F.2
Brannath, W.3
Glimm, E.4
Posch, M.5
-
62
-
-
77953666447
-
Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development
-
Quinlan J, Gaydos B, Maca J, Krams M. Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development. Clin Trials. 2010; 7:167-73.
-
(2010)
Clin Trials
, vol.7
, pp. 167-173
-
-
Quinlan, J.1
Gaydos, B.2
Maca, J.3
Krams, M.4
-
63
-
-
84864798414
-
Practical considerations and strategies for executing adaptive clinical trials
-
He W, Kuznetsova OM, Harmer M, Leahy C, Anderson K, Dossin N, et al.Practical considerations and strategies for executing adaptive clinical trials. Ther Innov Regul Sci. 2012; 46:160-74.
-
(2012)
Ther Innov Regul Sci
, vol.46
, pp. 160-174
-
-
He, W.1
Kuznetsova, O.M.2
Harmer, M.3
Leahy, C.4
Anderson, K.5
Dossin, N.6
-
64
-
-
84987938831
-
Practical considerations for adaptive trial design and implementation
-
New York: Springer
-
He W, Pinheiro J, Kuznetsova OM. Practical considerations for adaptive trial design and implementation. New York: Springer; 2014.
-
(2014)
-
-
He, W.1
Pinheiro, J.2
Kuznetsova, O.M.3
-
65
-
-
85021098083
-
The role of adaptive trial designs in drug development
-
Curtin F, Heritier S. The role of adaptive trial designs in drug development. Expert Rev Clin Pharmacol. 2017; 10:727-36.
-
(2017)
Expert Rev Clin Pharmacol
, vol.10
, pp. 727-736
-
-
Curtin, F.1
Heritier, S.2
-
66
-
-
84959515785
-
Implementation of adaptive methods in early-phase clinical trials
-
Petroni GR, Wages NA, Paux G, Dubois F. Implementation of adaptive methods in early-phase clinical trials. Stat Med. 2017; 36:215-24.
-
(2017)
Stat Med
, vol.36
, pp. 215-224
-
-
Petroni, G.R.1
Wages, N.A.2
Paux, G.3
Dubois, F.4
-
67
-
-
67650216185
-
Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial
-
Sydes MR, Parmar MKB, James ND, Clarke NW, Dearnaley DP, Mason MD, et al.Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials. 2009; 10:39.
-
(2009)
Trials
, vol.10
, pp. 39
-
-
Sydes, M.R.1
Parmar, M.K.B.2
James, N.D.3
Clarke, N.W.4
Dearnaley, D.P.5
Mason, M.D.6
-
68
-
-
84883027307
-
Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study
-
Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, et al.Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012; 6:1296-304.
-
(2012)
J Diabetes Sci Technol
, vol.6
, pp. 1296-1304
-
-
Spencer, K.1
Colvin, K.2
Braunecker, B.3
Brackman, M.4
Ripley, J.5
Hines, P.6
-
69
-
-
85009465989
-
DIA's Adaptive Design Scientific Working Group (ADSWG): best practices case studies for 'less well-understood' adaptive designs
-
Miller E, Gallo P, He W, Kammerman LA, Koury K, Maca J, et al.DIA's Adaptive Design Scientific Working Group (ADSWG): best practices case studies for 'less well-understood' adaptive designs. Ther Innov Regul Sci. 2017; 51:77-88.
-
(2017)
Ther Innov Regul Sci
, vol.51
, pp. 77-88
-
-
Miller, E.1
Gallo, P.2
He, W.3
Kammerman, L.A.4
Koury, K.5
Maca, J.6
-
70
-
-
33748560148
-
An overview of statistical approaches for adaptive designs and design modifications
-
Schäfer H, Timmesfeld N, Müller HH. An overview of statistical approaches for adaptive designs and design modifications. Biom J. 2006; 48:507-20.
-
(2006)
Biom J
, vol.48
, pp. 507-520
-
-
Schäfer, H.1
Timmesfeld, N.2
Müller, H.H.3
-
73
-
-
85042565901
-
-
In: Group sequential methods with applications to clinical trials. Boca Raton: Chapman & Hall/CRC
-
Jennison C, Turnbull BW. Analysis following a sequential test. In: Group sequential methods with applications to clinical trials. Boca Raton: Chapman & Hall/CRC: 2000. p. 171-87.
-
(2000)
Analysis following a sequential test
, pp. 171-187
-
-
Jennison, C.1
Turnbull, B.W.2
-
74
-
-
0001136460
-
Parameter estimation following group sequential hypothesis testing
-
Emerson SS, Fleming TR. Parameter estimation following group sequential hypothesis testing. Biometrika. 1990; 77:875-92.
-
(1990)
Biometrika
, vol.77
, pp. 875-892
-
-
Emerson, S.S.1
Fleming, T.R.2
-
75
-
-
0000949287
-
Unbiased estimation following a group sequential test
-
Liu A, Hall WJ. Unbiased estimation following a group sequential test. Biometrika. 1999; 86:71-8.
-
(1999)
Biometrika
, vol.86
, pp. 71-78
-
-
Liu, A.1
Hall, W.J.2
-
76
-
-
54349104178
-
Unbiased estimation of selected treatment means in two-stage trials
-
Bowden J, Glimm E. Unbiased estimation of selected treatment means in two-stage trials. Biometrical J. 2008; 50:515-27.
-
(2008)
Biometrical J
, vol.50
, pp. 515-527
-
-
Bowden, J.1
Glimm, E.2
-
77
-
-
84894522079
-
Conditionally unbiased and near unbiased estimation of the selected treatment mean for multistage drop-the-losers trials
-
Bowden J, Glimm E. Conditionally unbiased and near unbiased estimation of the selected treatment mean for multistage drop-the-losers trials. Biometrical J. 2014; 56:332-49.
-
(2014)
Biometrical J
, vol.56
, pp. 332-349
-
-
Bowden, J.1
Glimm, E.2
-
78
-
-
0001547530
-
On the bias of maximum likelihood estimation following a sequential test
-
Whitehead J. On the bias of maximum likelihood estimation following a sequential test. Biometrika. 1986; 73:573-81.
-
(1986)
Biometrika
, vol.73
, pp. 573-581
-
-
Whitehead, J.1
-
79
-
-
78650239326
-
An exact method for analysis following a two-stage phase II cancer clinical trial
-
Jovic G, Whitehead J. An exact method for analysis following a two-stage phase II cancer clinical trial. Stat Med. 2010; 29:3118-25.
-
(2010)
Stat Med
, vol.29
, pp. 3118-3125
-
-
Jovic, G.1
Whitehead, J.2
-
80
-
-
84876448156
-
Shrinkage estimation in two-stage adaptive designs with midtrial treatment selection
-
Carreras M, Brannath W. Shrinkage estimation in two-stage adaptive designs with midtrial treatment selection. Stat Med. 2013; 32:1677-90.
-
(2013)
Stat Med
, vol.32
, pp. 1677-1690
-
-
Carreras, M.1
Brannath, W.2
-
81
-
-
85020407913
-
Estimation in multi-arm two-stage trials with treatment selection and time-to-event endpoint
-
Brueckner M, Titman A, Jaki T. Estimation in multi-arm two-stage trials with treatment selection and time-to-event endpoint. Stat Med. 2017; 36:3137-53.
-
(2017)
Stat Med
, vol.36
, pp. 3137-3153
-
-
Brueckner, M.1
Titman, A.2
Jaki, T.3
-
82
-
-
84870060247
-
Identifying combined design and analysis procedures in two-stage trials with a binary end point
-
Bowden J, Wason J. Identifying combined design and analysis procedures in two-stage trials with a binary end point. Stat Med. 2012; 31:3874-84.
-
(2012)
Stat Med
, vol.31
, pp. 3874-3884
-
-
Bowden, J.1
Wason, J.2
-
83
-
-
84872592627
-
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. Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome. Trials. 2013; 14:23.
-
(2013)
Trials
, vol.14
, pp. 23
-
-
Choodari-Oskooei, B.1
Parmar, M.K.2
Royston, P.3
Bowden, J.4
-
85
-
-
84884703868
-
Exact inference for adaptive group sequential designs
-
Gao P, Liu L, Mehta C. Exact inference for adaptive group sequential designs. Stat Med. 2013; 32:3991-4005.
-
(2013)
Stat Med
, vol.32
, pp. 3991-4005
-
-
Gao, P.1
Liu, L.2
Mehta, C.3
-
86
-
-
84935687765
-
Estimation after subpopulation selection in adaptive seamless trials
-
Kimani PK, Todd S, Stallard N. Estimation after subpopulation selection in adaptive seamless trials. Stat Med. 2015; 34:2581-601.
-
(2015)
Stat Med
, vol.34
, pp. 2581-2601
-
-
Kimani, P.K.1
Todd, S.2
Stallard, N.3
-
88
-
-
0029589385
-
Designed extension of studies based on conditional power
-
Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics. 1995; 51:1315-24.
-
(1995)
Biometrics
, vol.51
, pp. 1315-1324
-
-
Proschan, M.A.1
Hunsberger, S.A.2
-
89
-
-
0345329168
-
Simple procedures for blinded sample size adjustment that do not affect the type I error rate
-
Kieser M, Friede T. Simple procedures for blinded sample size adjustment that do not affect the type I error rate. Stat Med. 2003; 22:3571-81.
-
(2003)
Stat Med
, vol.22
, pp. 3571-3581
-
-
Kieser, M.1
Friede, T.2
-
90
-
-
84952701035
-
Maximum type I error rate inflation from sample size reassessment when investigators are blind to treatment labels
-
zebrowska M, Posch M, Magirr D. Maximum type I error rate inflation from sample size reassessment when investigators are blind to treatment labels. Stat Med. 2016; 35:1972-84.
-
(2016)
Stat Med
, vol.35
, pp. 1972-1984
-
-
Zebrowska, M.1
Posch, M.2
Magirr, D.3
-
91
-
-
84976869630
-
Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes
-
Bratton DJ, Parmar MKB, Phillips PPJ, Choodari-Oskooei B. Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes. Trials. 2016; 17:309.
-
(2016)
Trials
, vol.17
, pp. 309
-
-
Bratton, D.J.1
Parmar, M.K.B.2
Phillips, P.P.J.3
Choodari-Oskooei, B.4
-
92
-
-
74749107462
-
Hierarchical testing of multiple endpoints in group-sequential trials
-
Glimm E, Maurer W, Bretz F. Hierarchical testing of multiple endpoints in group-sequential trials. Stat Med. 2010; 29:219-28.
-
(2010)
Stat Med
, vol.29
, pp. 219-228
-
-
Glimm, E.1
Maurer, W.2
Bretz, F.3
-
93
-
-
84874972543
-
A group sequential Holm procedure with multiple primary endpoints
-
Ye Y, Li A, Liu L, Yao B. A group sequential Holm procedure with multiple primary endpoints. Stat Med. 2013; 32:1112-24.
-
(2013)
Stat Med
, vol.32
, pp. 1112-1124
-
-
Ye, Y.1
Li, A.2
Liu, L.3
Yao, B.4
-
94
-
-
85042563633
-
-
In: Dmitrienko A, Tamhane AC, Bretz F, editors. Multiple testing problems in pharmaceutical statistics. Boca Raton: Chapman & Hall/CRC
-
Maurer W, Branson M, Posch M. Adaptive designs and confirmatory hypothesis testing In: Dmitrienko A, Tamhane AC, Bretz F, editors. Multiple testing problems in pharmaceutical statistics. Boca Raton: Chapman & Hall/CRC: 2010.
-
(2010)
Adaptive designs and confirmatory hypothesis testing
-
-
Maurer, W.1
Branson, M.2
Posch, M.3
-
95
-
-
30944469129
-
Testing and estimation in flexible group sequential designs with adaptive treatment selection
-
Posch M, Koenig F, Branson M, Brannath W, Dunger-Baldauf C, Bauer P. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Stat Med. 2005; 24:3697-714.
-
(2005)
Stat Med
, vol.24
, pp. 3697-3714
-
-
Posch, M.1
Koenig, F.2
Branson, M.3
Brannath, W.4
Dunger-Baldauf, C.5
Bauer, P.6
-
96
-
-
84910039155
-
Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?
-
Wason JMS, Stecher L, Mander AP. Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?Trials. 2014; 15:364.
-
(2014)
Trials
, vol.15
, pp. 364
-
-
Wason, J.M.S.1
Stecher, L.2
Mander, A.P.3
-
97
-
-
79957528017
-
Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program
-
Wang SJ, Hung HMJ, O'Neill R. Regulatory perspectives on multiplicity in adaptive design clinical trials throughout a drug development program. J Biopharm Stat. 2011; 21:846-59.
-
(2011)
J Biopharm Stat
, vol.21
, pp. 846-859
-
-
Wang, S.J.1
Hung, H.M.J.2
O'Neill, R.3
-
98
-
-
85034804316
-
-
Accessed 7 Jul 2017.
-
European Medicines Agency. Guideline on multiplicity issues in clinical trials (draft). 2017. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/03/WC500224998.pdf. Accessed 7 Jul 2017.
-
(2017)
Guideline on multiplicity issues in clinical trials (draft)
-
-
-
103
-
-
33847666453
-
Practical Bayesian adaptive randomisation in clinical trials
-
Thall PF, Wathen JK. Practical Bayesian adaptive randomisation in clinical trials. Eur J Cancer. 2007; 43:859-66.
-
(2007)
Eur J Cancer
, vol.43
, pp. 859-866
-
-
Thall, P.F.1
Wathen, J.K.2
-
105
-
-
84864019962
-
Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods
-
Kimani PK, Glimm E, Maurer W, Hutton JL, Stallard N. Practical guidelines for adaptive seamless phase II/III clinical trials that use Bayesian methods. Stat Med. 2012; 31:2068-85.
-
(2012)
Stat Med
, vol.31
, pp. 2068-2085
-
-
Kimani, P.K.1
Glimm, E.2
Maurer, W.3
Hutton, J.L.4
Stallard, N.5
-
106
-
-
84960334957
-
An overview of the design and conduct of the BATTLE trials
-
Liu S, Lee JJ. An overview of the design and conduct of the BATTLE trials. Chin Clin Oncol. 2015; 4:33.
-
(2015)
Chin Clin Oncol
, vol.4
, pp. 33
-
-
Liu, S.1
Lee, J.J.2
-
107
-
-
24144464254
-
Bayesian adaptive designs for clinical trials
-
Cheng Y, Shen Y. Bayesian adaptive designs for clinical trials. Biometrika. 2005; 92:633-46.
-
(2005)
Biometrika
, vol.92
, pp. 633-646
-
-
Cheng, Y.1
Shen, Y.2
-
108
-
-
34250366338
-
Bayesian decision-theoretic group sequential clinical trial design based on a quadratic loss function: a frequentist evaluation
-
Lewis RJ, Lipsky AM, Berry DA. Bayesian decision-theoretic group sequential clinical trial design based on a quadratic loss function: a frequentist evaluation. Clin Trials. 2007; 4:5-14.
-
(2007)
Clin Trials
, vol.4
, pp. 5-14
-
-
Lewis, R.J.1
Lipsky, A.M.2
Berry, D.A.3
-
109
-
-
84926142505
-
Bayesian designs and the control of frequentist characteristics: a practical solution
-
Ventz S, Trippa L. Bayesian designs and the control of frequentist characteristics: a practical solution. Biometrics. 2015; 71:218-26.
-
(2015)
Biometrics
, vol.71
, pp. 218-226
-
-
Ventz, S.1
Trippa, L.2
-
110
-
-
36348967229
-
Frequentist evaluation of group sequential clinical trial designs
-
Emerson SS, Kittelson JM, Gillen DL. Frequentist evaluation of group sequential clinical trial designs. Stat Med. 2007; 26:5047-80.
-
(2007)
Stat Med
, vol.26
, pp. 5047-5080
-
-
Emerson, S.S.1
Kittelson, J.M.2
Gillen, D.L.3
-
111
-
-
33947102564
-
Bayesian evaluation of group sequential clinical trial designs
-
Emerson SS, Kittelson JM, Gillen DL. Bayesian evaluation of group sequential clinical trial designs. Stat Med. 2007; 26:1431-49.
-
(2007)
Stat Med
, vol.26
, pp. 1431-1449
-
-
Emerson, S.S.1
Kittelson, J.M.2
Gillen, D.L.3
-
112
-
-
84908216560
-
A practical guide to Bayesian group sequential designs
-
Gsponer T, Gerber F, Bornkamp B, Ohlssen D, Vandemeulebroecke M, Schmidli H. A practical guide to Bayesian group sequential designs. Pharm Stat. 2014; 13:71-80.
-
(2014)
Pharm Stat
, vol.13
, pp. 71-80
-
-
Gsponer, T.1
Gerber, F.2
Bornkamp, B.3
Ohlssen, D.4
Vandemeulebroecke, M.5
Schmidli, H.6
-
113
-
-
21244466674
-
Decision-making in a phase II clinical trial: a new approach combining Bayesian and frequentist concepts
-
Stallard N, Whitehead J, Cleall S. Decision-making in a phase II clinical trial: a new approach combining Bayesian and frequentist concepts. Pharm Stat. 2005; 4:119-28.
-
(2005)
Pharm Stat
, vol.4
, pp. 119-128
-
-
Stallard, N.1
Whitehead, J.2
Cleall, S.3
-
114
-
-
84864020956
-
A Bayesian-frequentist two-stage single-arm phase II clinical trial design
-
Dong G, Shih WJ, Moore D, Quan H, Marcella S. A Bayesian-frequentist two-stage single-arm phase II clinical trial design. Stat Med. 2012; 31:2055-67.
-
(2012)
Stat Med
, vol.31
, pp. 2055-2067
-
-
Dong, G.1
Shih, W.J.2
Moore, D.3
Quan, H.4
Marcella, S.5
-
115
-
-
84861098716
-
Adaptive blinded sample size adjustment for comparing two normal means-a mostly Bayesian approach
-
Hartley AM. Adaptive blinded sample size adjustment for comparing two normal means-a mostly Bayesian approach. Pharm Stat. 2012; 11:230-40.
-
(2012)
Pharm Stat
, vol.11
, pp. 230-240
-
-
Hartley, A.M.1
-
116
-
-
33750884934
-
Confidentiality and trial integrity issues for adaptive designs
-
Gallo P. Confidentiality and trial integrity issues for adaptive designs. Drug Inf J. 2006; 40:445-50.
-
(2006)
Drug Inf J
, vol.40
, pp. 445-450
-
-
Gallo, P.1
-
117
-
-
84897954467
-
Predicting clinical trial results based on announcements of interim analyses
-
Broglio KR, Stivers DN, Berry DA. Predicting clinical trial results based on announcements of interim analyses. Trials. 2014; 15:73.
-
(2014)
Trials
, vol.15
, pp. 73
-
-
Broglio, K.R.1
Stivers, D.N.2
Berry, D.A.3
-
118
-
-
84863475669
-
On the independence of data monitoring committee in adaptive design clinical trials
-
Chow SC, Corey R, Lin M. On the independence of data monitoring committee in adaptive design clinical trials. J Biopharm Stat. 2012; 22:853-67.
-
(2012)
J Biopharm Stat
, vol.22
, pp. 853-867
-
-
Chow, S.C.1
Corey, R.2
Lin, M.3
-
119
-
-
65649112030
-
Exploring changes in treatment effects across design stages in adaptive trials
-
Friede T, Henderson R. Exploring changes in treatment effects across design stages in adaptive trials. Pharm Stat. 2009; 8:62-72.
-
(2009)
Pharm Stat
, vol.8
, pp. 62-72
-
-
Friede, T.1
Henderson, R.2
-
120
-
-
65649086704
-
What should be the role of homogeneity testing in adaptive trials?
-
Gallo P, Chuang-Stein C. What should be the role of homogeneity testing in adaptive trials?Pharm Stat. 2009; 8:1-4.
-
(2009)
Pharm Stat
, vol.8
, pp. 1-4
-
-
Gallo, P.1
Chuang-Stein, C.2
-
121
-
-
84930399719
-
No solution yet for combining two independent studies in the presence of heterogeneity
-
Gonnermann A, Framke T, Großhennig A, Koch A. No solution yet for combining two independent studies in the presence of heterogeneity. Stat Med. 2015; 34:2476-80.
-
(2015)
Stat Med
, vol.34
, pp. 2476-2480
-
-
Gonnermann, A.1
Framke, T.2
Großhennig, A.3
Koch, A.4
-
122
-
-
74749102937
-
Testing for qualitative interactions between stages in an adaptive study
-
Parker RA. Testing for qualitative interactions between stages in an adaptive study. Stat Med. 2010; 29:210-18.
-
(2010)
Stat Med
, vol.29
, pp. 210-218
-
-
Parker, R.A.1
-
123
-
-
84888137381
-
Unblinded adaptive statistical information design based on clinical endpoint or biomarker
-
Wang SJ, Brannath W, Brückner M, Hung HMJ, Koch A. Unblinded adaptive statistical information design based on clinical endpoint or biomarker. Stat Biopharm Res. 2013; 5:293-310.
-
(2013)
Stat Biopharm Res
, vol.5
, pp. 293-310
-
-
Wang, S.J.1
Brannath, W.2
Brückner, M.3
Hung, H.M.J.4
Koch, A.5
-
124
-
-
0035822324
-
Systematic reviews in health care: assessing the quality of controlled clinical trials
-
Jüni P, Altman DG, Egger M. Systematic reviews in health care: assessing the quality of controlled clinical trials. BMJ. 2001; 323:42-6.
-
(2001)
BMJ
, vol.323
, pp. 42-46
-
-
Jüni, P.1
Altman, D.G.2
Egger, M.3
-
125
-
-
77950189829
-
CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
-
Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340:c332.
-
(2010)
BMJ
, vol.340
-
-
Schulz, K.F.1
Altman, D.G.2
Moher, D.3
-
126
-
-
33646257465
-
Application of adaptive designs-a review
-
Bauer P, Einfalt J. Application of adaptive designs-a review. Biometrical J. 2006; 48:493-506.
-
(2006)
Biometrical J
, vol.48
, pp. 493-506
-
-
Bauer, P.1
Einfalt, J.2
-
127
-
-
84889644506
-
Standards for the design, conduct, and evaluation of adaptive randomized clinical trials
-
Washington: Patient-Centered Outcomes Research Institute, Accessed 7 Jul 2017.
-
Detry MA, Lewis RJ, Broglio KR, Connor JT, Berry SM, Berry DA. Standards for the design, conduct, and evaluation of adaptive randomized clinical trials. Washington: Patient-Centered Outcomes Research Institute; 2012. http://www.pcori.org/assets/Standards-for-the-Design-Conduct-and-Evaluation-of-Adaptive-Randomized-Clinical-Trials.pdf. Accessed 7 Jul 2017.
-
(2012)
-
-
Detry, M.A.1
Lewis, R.J.2
Broglio, K.R.3
Connor, J.T.4
Berry, S.M.5
Berry, D.A.6
-
128
-
-
84903361151
-
Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
-
Lorch U, O'Kane M, Taubel J. Three steps to writing adaptive study protocols in the early phase clinical development of new medicines. BMC Med Res Methodol. 2014; 14:84.
-
(2014)
BMC Med Res Methodol
, vol.14
, pp. 84
-
-
Lorch, U.1
O'Kane, M.2
Taubel, J.3
-
129
-
-
84951133315
-
An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review
-
Stevely A, Dimairo M, Todd S, Julious SA, Nicholl J, Hind D, et al.An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review. PLoS One. 2015; 10:e0141104.
-
(2015)
PLoS One
, vol.10
-
-
Stevely, A.1
Dimairo, M.2
Todd, S.3
Julious, S.A.4
Nicholl, J.5
Hind, D.6
-
131
-
-
84971508133
-
Rendering the 3 + 3 design to rest: more efficient approaches to oncology dose-finding trials in the era of targeted therapy
-
Nie L, Rubin EH, Mehrotra N, Pinheiro J, Fernandes LL, Roy A, et al.Rendering the 3 + 3 design to rest: more efficient approaches to oncology dose-finding trials in the era of targeted therapy. Clin Cancer Res. 2016; 22:2623-9.
-
(2016)
Clin Cancer Res
, vol.22
, pp. 2623-2629
-
-
Nie, L.1
Rubin, E.H.2
Mehrotra, N.3
Pinheiro, J.4
Fernandes, L.L.5
Roy, A.6
-
132
-
-
85042564335
-
A quick guide why not to use A+B designs
-
Accessed 7 Jul 2017.
-
Adaptive Designs Working Group of the MRC Network of Hubs for Trials Methodology Research. A quick guide why not to use A+B designs. 2016. https://www.methodologyhubs.mrc.ac.uk/files/6814/6253/2385/A_quick_guide_why_not_to_use_AB_designs.pdf. Accessed 7 Jul 2017.
-
(2016)
-
-
-
133
-
-
84904500274
-
When is a seamless study desirable? Case studies from different pharmaceutical sponsors
-
Cuffe RL, Lawrence D, Stone A, Vandemeulebroecke M. When is a seamless study desirable? Case studies from different pharmaceutical sponsors. Pharm Stat. 2014; 13:229-37.
-
(2014)
Pharm Stat
, vol.13
, pp. 229-237
-
-
Cuffe, R.L.1
Lawrence, D.2
Stone, A.3
Vandemeulebroecke, M.4
-
134
-
-
84999532085
-
Multi-arm clinical trials with treatment selection: what can be gained and at what price?
-
Jaki T. Multi-arm clinical trials with treatment selection: what can be gained and at what price?Clin Investig. 2015; 5:393-9.
-
(2015)
Clin Investig
, vol.5
, pp. 393-399
-
-
Jaki, T.1
-
135
-
-
46349091495
-
Adaptive clinical trials: progress and challenges
-
Coffey CS, Kairalla JA. Adaptive clinical trials: progress and challenges. Drugs R D. 2008; 9:229-42.
-
(2008)
Drugs R D
, vol.9
, pp. 229-242
-
-
Coffey, C.S.1
Kairalla, J.A.2
-
136
-
-
85038437325
-
A pragmatic approach to the design and calibration of a Bayesian CRM dose finding trial
-
Cole M, Stocken D, Yap C. A pragmatic approach to the design and calibration of a Bayesian CRM dose finding trial. Trials. 2015;16 Suppl2:P210.
-
(2015)
Trials
, vol.16
-
-
Cole, M.1
Stocken, D.2
Yap, C.3
-
137
-
-
85038438739
-
Dose transition pathways: the missing link between complex dose-finding designs and simple decision making
-
Yap C, Billingham LJ, Cheung YK, Craddock C, O'Quigley J. Dose transition pathways: the missing link between complex dose-finding designs and simple decision making. Clin Cancer Res. 2017; 23:7440-7.
-
(2017)
Clin Cancer Res
, vol.23
, pp. 7440-7447
-
-
Yap, C.1
Billingham, L.J.2
Cheung, Y.K.3
Craddock, C.4
O'Quigley, J.5
-
138
-
-
85038419303
-
Implementation of adaptive dose-finding designs in two early phase haematological trials: clinical, operational, and methodological challenges
-
Yap C, Craddock C, Collins G, Khan J, Siddique S, Billingham L. Implementation of adaptive dose-finding designs in two early phase haematological trials: clinical, operational, and methodological challenges. Trials. 2013;14 Suppl 1:O75.
-
(2013)
Trials
, vol.14
-
-
Yap, C.1
Craddock, C.2
Collins, G.3
Khan, J.4
Siddique, S.5
Billingham, L.6
-
139
-
-
85042560303
-
A study of donor ex-vivo lung perfusion in UK lung transplantation (DEVELOP-UK)
-
Fisher AJ, Yonan N, Mascaro J, Marczin N, Tsui S, Simon A, et al. A study of donor ex-vivo lung perfusion in UK lung transplantation (DEVELOP-UK). J Heart Lung Transplant. 2016;35 Suppl 4:S80.
-
(2016)
J Heart Lung Transplant
, vol.35
-
-
Fisher, A.J.1
Yonan, N.2
Mascaro, J.3
Marczin, N.4
Tsui, S.5
Simon, A.6
-
140
-
-
84866145248
-
Flexible trial design in practice-stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial
-
Sydes MR, Parmar MKB, Mason MD, Clarke NW, Amos C, Anderson J, et al.Flexible trial design in practice-stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials. 2012; 13:168.
-
(2012)
Trials
, vol.13
, pp. 168
-
-
Sydes, M.R.1
Parmar, M.K.B.2
Mason, M.D.3
Clarke, N.W.4
Amos, C.5
Anderson, J.6
-
141
-
-
85042558588
-
The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental arm
-
Gaunt P, Mehanna H, Yap C. The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental arm. Trials. 2015;16 Suppl 2:O16.
-
(2015)
Trials
, vol.16
-
-
Gaunt, P.1
Mehanna, H.2
Yap, C.3
-
142
-
-
84943753935
-
Prospective study evaluating the relative sensitivity of 18F-NaF PET/CT for detecting skeletal metastases from renal cell carcinoma in comparison to multidetector CT and 99mTc-MDP bone scintigraphy, using an adaptive trial design
-
Gerety EL, Lawrence EM, Wason J, Yan H, Hilborne S, Buscombe J, et al.Prospective study evaluating the relative sensitivity of 18F-NaF PET/CT for detecting skeletal metastases from renal cell carcinoma in comparison to multidetector CT and 99mTc-MDP bone scintigraphy, using an adaptive trial design. Ann Oncol. 2015; 26:2113-8.
-
(2015)
Ann Oncol
, vol.26
, pp. 2113-2118
-
-
Gerety, E.L.1
Lawrence, E.M.2
Wason, J.3
Yan, H.4
Hilborne, S.5
Buscombe, J.6
-
143
-
-
84864238949
-
Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design
-
Ho TW, Pearlman E, Lewis D, Hämäläinen M, Connor K, Michelson D, et al.Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. Cephalalgia. 2012; 32:750-65.
-
(2012)
Cephalalgia
, vol.32
, pp. 750-765
-
-
Ho, T.W.1
Pearlman, E.2
Lewis, D.3
Hämäläinen, M.4
Connor, K.5
Michelson, D.6
-
144
-
-
84888132560
-
Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations
-
Wang SJ, Hung HMJ. Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations. Contemp Clin Trials. 2013; 36:673-81.
-
(2013)
Contemp Clin Trials
, vol.36
, pp. 673-681
-
-
Wang, S.J.1
Hung, H.M.J.2
-
145
-
-
84894477310
-
Evaluating many treatments and biomarkers in oncology: a new design
-
Kaplan R, Maughan T, Crook A, Fisher D, Wilson R, Brown L, et al.Evaluating many treatments and biomarkers in oncology: a new design. J Clin Oncol. 2013; 31:4562-8.
-
(2013)
J Clin Oncol
, vol.31
, pp. 4562-4568
-
-
Kaplan, R.1
Maughan, T.2
Crook, A.3
Fisher, D.4
Wilson, R.5
Brown, L.6
-
146
-
-
84901931670
-
Rationale and study design of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D): a non-randomised, open label, adaptive dose finding trial
-
Waldron-Lynch F, Kareclas P, Irons K, Walker NM, Mander A, Wicker LS, et al. Rationale and study design of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D): a non-randomised, open label, adaptive dose finding trial. BMJ Open. 2014; 4:e005559.
-
(2014)
BMJ Open
, vol.4
-
-
Waldron-Lynch, F.1
Kareclas, P.2
Irons, K.3
Walker, N.M.4
Mander, A.5
Wicker, L.S.6
-
147
-
-
84944316022
-
Patient-centric trials for therapeutic development in precision oncology
-
Biankin AV, Piantadosi S, Hollingsworth SJ. Patient-centric trials for therapeutic development in precision oncology. Nature. 2015; 526:361-70.
-
(2015)
Nature
, vol.526
, pp. 361-370
-
-
Biankin, A.V.1
Piantadosi, S.2
Hollingsworth, S.J.3
-
148
-
-
84977650991
-
Biomarker-guided adaptive trial designs in phase II and phase III: a methodological review
-
Antoniou M, Jorgensen AL, Kolamunnage-Dona R. Biomarker-guided adaptive trial designs in phase II and phase III: a methodological review. PLoS One. 2016; 11:e0149803.
-
(2016)
PLoS One
, vol.11
-
-
Antoniou, M.1
Jorgensen, A.L.2
-
149
-
-
84921847585
-
Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM)
-
Warner P, Weir CJ, Hansen CH, Douglas A, Madhra M, Hillier SG, et al. Low-dose dexamethasone as a treatment for women with heavy menstrual bleeding: protocol for response-adaptive randomised placebo-controlled dose-finding parallel group trial (DexFEM). BMJ Open. 2015; 5:e006837.
-
(2015)
BMJ Open
, vol.5
-
-
Warner, P.1
Weir, C.J.2
Hansen, C.H.3
Douglas, A.4
Madhra, M.5
Hillier, S.G.6
-
150
-
-
72149134613
-
Planning and executing response-adaptive learn-phase clinical trials: 2. case studies
-
Fardipour P, Littman G, Burns DD, Dragalin V, Padmanabhan SK, Parke T, et al.Planning and executing response-adaptive learn-phase clinical trials: 2. case studies. Drug Inf J. 2009; 43:725-34.
-
(2009)
Drug Inf J
, vol.43
, pp. 725-734
-
-
Fardipour, P.1
Littman, G.2
Burns, D.D.3
Dragalin, V.4
Padmanabhan, S.K.5
Parke, T.6
-
151
-
-
84991273589
-
Response-adaptive clinical trials: case studies in the medical literature
-
Grieve AP. Response-adaptive clinical trials: case studies in the medical literature. Pharm Stat. 2017; 16:64-86.
-
(2017)
Pharm Stat
, vol.16
, pp. 64-86
-
-
Grieve, A.P.1
-
152
-
-
84864022490
-
A novel phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer
-
Whitehead J, Thygesen H, Jaki T, Davies S, Halford S, Turner H, et al.A novel phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer. Stat Med. 2012; 31:1931-43.
-
(2012)
Stat Med
, vol.31
, pp. 1931-1943
-
-
Whitehead, J.1
Thygesen, H.2
Jaki, T.3
Davies, S.4
Halford, S.5
Turner, H.6
-
153
-
-
85042557717
-
Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design
-
Khan J, Yap C, Clark R, Fenwick N, Marin D. Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design. Trials. 2013;14 Suppl 1:P20.
-
(2013)
Trials
, vol.14
-
-
Khan, J.1
Yap, C.2
Clark, R.3
Fenwick, N.4
Marin, D.5
-
154
-
-
85025069055
-
Implementing the EffTox dose-finding design in the Matchpoint trial
-
Brock K, Billingham L, Copland M, Siddique S, Sirovica M, Yap C. Implementing the EffTox dose-finding design in the Matchpoint trial. BMC Med Res Methodol. 2017; 17:112.
-
(2017)
BMC Med Res Methodol
, vol.17
, pp. 112
-
-
Brock, K.1
Billingham, L.2
Copland, M.3
Siddique, S.4
Sirovica, M.5
Yap, C.6
|