-
1
-
-
84973309295
-
Assessing the gold standard-lessons from the history of RCTs
-
Bothwell LE, Greene JA, Podolsky SH, et al. Assessing the gold standard-lessons from the history of RCTs. N Engl J Med 2016;374:2175-81
-
(2016)
N Engl J Med
, vol.374
, pp. 2175-2181
-
-
Bothwell, L.E.1
Greene, J.A.2
Podolsky, S.H.3
-
2
-
-
85053152920
-
-
United States Government R. 34, Tsunami Warning, Education, and Research Act of 2015. 114th Congress.
-
United States Government. Rules committee print 114-67, text of House amendment to the Senate, amendment to H. R. 34, Tsunami Warning, Education, and Research Act of 2015, 2016:162-3. 114th Congress. http:// docs. house. gov/ billsthisweek/ 20161128/ CPRT-114-HPRT-RU00-SAHR34. pdf
-
(2016)
Rules Committee Print 114-67, Text of House Amendment to the Senate, Amendment to H
, pp. 162-163
-
-
-
3
-
-
0017743105
-
Adaptive treatment assignment methods and clinical trials
-
Simon R. Adaptive treatment assignment methods and clinical trials. Biometrics 1977;33:743-9
-
(1977)
Biometrics
, vol.33
, pp. 743-749
-
-
Simon, R.1
-
4
-
-
0001798066
-
A survey of adaptive sampling for clinical trials
-
In: Elashoff RM, eds. New York: Academic Press
-
Hoel DG, Sobel M, Weiss GH. A survey of adaptive sampling for clinical trials. In: Elashoff RM, eds. Perspectives in Biometrics. New York: Academic Press, 1975:30
-
(1975)
Perspectives in Biometrics
, pp. 30
-
-
Hoel, D.G.1
Sobel, M.2
Weiss, G.H.3
-
5
-
-
77954875817
-
-
U. S. Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. MD: Silver Spring
-
U. S. Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: Adaptive design clinical trials for drugs and biologics (Draft Guidance). MD: Silver Spring, 2010
-
(2010)
Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (Draft Guidance)
-
-
-
6
-
-
0018346971
-
Allocation of patients to treatment in clinical trials
-
Pocock SJ. Allocation of patients to treatment in clinical trials. Biometrics 1979;35:183-97
-
(1979)
Biometrics
, vol.35
, pp. 183-197
-
-
Pocock, S.J.1
-
7
-
-
0026347876
-
A decade of progress in statistical methodology for clinical trials
-
Simon R. A decade of progress in statistical methodology for clinical trials. Stat Med 1991;10:1789-817
-
(1991)
Stat Med
, vol.10
, pp. 1789-1817
-
-
Simon, R.1
-
8
-
-
33749332508
-
Issues in the use of adaptive clinical trial designs
-
Emerson SS. Issues in the use of adaptive clinical trial designs. Stat Med 2006;25:3270-96
-
(2006)
Stat Med
, vol.25
, pp. 3270-3296
-
-
Emerson, S.S.1
-
9
-
-
84866735197
-
An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project
-
Meurer WJ, Lewis RJ, Tagle D, et al. An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project. Ann Emerg Med 2012;60:451-7
-
(2012)
Ann Emerg Med
, vol.60
, pp. 451-457
-
-
Meurer, W.J.1
Lewis, R.J.2
Tagle, D.3
-
12
-
-
78249272973
-
Adaptive methods: Telling "the rest of the story"
-
Emerson SS, Fleming TR. Adaptive methods: Telling "the rest of the story". J Biopharm Stat 2010;20:1150-65
-
(2010)
J Biopharm Stat
, vol.20
, pp. 1150-1165
-
-
Emerson, S.S.1
Fleming, T.R.2
-
13
-
-
33646245937
-
Adaptive designs in clinical drug development-an executive summary of the PhRMA Working Group
-
Gallo P, Chuang-Stein C, Dragalin V, et al. 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
-
14
-
-
44949171503
-
Adaptive design methods in clinical trials-a review
-
Chow S-C, Chang M. Adaptive design methods in clinical trials-a review. Orphanet J Rare Dis 2008;3:11-13
-
(2008)
Orphanet J Rare Dis
, vol.3
, pp. 11-13
-
-
Chow, S.-C.1
Chang, M.2
-
15
-
-
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, 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
-
16
-
-
84978064544
-
Adaptive designs for clinical trials
-
Bhatt DL, Mehta C. Adaptive designs for clinical trials. N Engl J Med 2016;375:65-74
-
(2016)
N Engl J Med
, vol.375
, pp. 65-74
-
-
Bhatt, D.L.1
Mehta, C.2
-
17
-
-
84903529904
-
Adaptive design: Results of 2012 survey on perception and use
-
Morgan CC, Huyck S, Jenkins M, et al. Adaptive design: results of 2012 survey on perception and use. Therap Innov Reg Sci 2014;48:473-81
-
(2014)
Therap Innov Reg Sci
, vol.48
, pp. 473-481
-
-
Morgan, C.C.1
Huyck, S.2
Jenkins, M.3
-
18
-
-
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, et al. 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
-
19
-
-
84961201800
-
Adaptive designs undertaken in clinical research: A review of registered clinical trials
-
Hatfield I, Allison A, Flight L, et al. 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
-
20
-
-
84959146839
-
CBER's experience with adaptive design clinical trials
-
Lin M, Lee S, Zhen B, et al. CBER's experience with adaptive design clinical trials. Therap Innov Reg Sci 2016;50:195-203
-
(2016)
Therap Innov Reg Sci
, vol.50
, pp. 195-203
-
-
Lin, M.1
Lee, S.2
Zhen, B.3
-
21
-
-
84992453953
-
Adaptive design practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013
-
Yang X, Thompson L, Chu J, et al. Adaptive design practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013. Therap Innov Reg Sci 2016:50: 710-717
-
(2016)
Therap Innov Reg Sci
, vol.50
, pp. 710-717
-
-
Yang, X.1
Thompson, L.2
Chu, J.3
-
23
-
-
84899999885
-
Adaptive clinical trial design
-
Chow S-C. Adaptive clinical trial design. Annu Rev Med 2014;65:405-15
-
(2014)
Annu Rev Med
, vol.65
, pp. 405-415
-
-
Chow, S.-C.1
-
24
-
-
85053169025
-
-
U. S. Food & Drug Administration. Drugs@FDA: FDA Approved Drug Products
-
U. S. Food & Drug Administration. Drugs@FDA: FDA Approved Drug Products. 2016 http://www. accessdata. fda. gov/ scripts/ cder/ drugsatfda
-
(2016)
-
-
-
25
-
-
0008348082
-
-
European Medicines Agency London: EMA
-
European Medicines Agency. European public assessment reports [Internet]. London: EMA, 2016. http://www. ema. europa. edu/ ema/ index. jsp? curl= pages/ medicines/ landing/ epar- search. jsp& mid= WC0b01ac058001d124
-
(2016)
European Public Assessment Reports [Internet]
-
-
-
26
-
-
79851493216
-
Biomedical publication trends by geographic area
-
Karlberg JPE. Biomedical publication trends by geographic area. Clin Trial Mag 2010;2:682-701
-
(2010)
Clin Trial Mag
, vol.2
, pp. 682-701
-
-
Karlberg, J.P.E.1
-
29
-
-
73949089207
-
Funding of US biomedical research, 2003-2008
-
Dorsey ER, de Roulet J, Thompson JP, et al. Funding of US biomedical research, 2003-2008. JAMA 2010;303:137-43
-
(2010)
JAMA
, vol.303
, pp. 137-143
-
-
Dorsey, E.R.1
De Roulet, J.2
Thompson, J.P.3
-
30
-
-
85053107482
-
CDER new drug review: 2015 update [Internet]
-
(cited 2016 Jun 26)
-
Jenkins JK. CDER new drug review: 2015 update [Internet]. [Place unknown]: FDA center for drug evaluation and research. 2015 http: //www. fda. gov/d ownl oads /Abo utFD A/Ce nter sOff?ices/ OfficeofMedicalProdu ctsa ndTo bacco/ CDE R/ UCM477020. pdf (cited 2016 Jun 26)
-
(2015)
[Place Unknown]: FDA Center for Drug Evaluation and Research
-
-
Jenkins, J.K.1
-
31
-
-
84862239891
-
Regulatory review of novel therapeutics-comparison of three regulatory agencies
-
Downing NS, Aminawung JA, Shah ND, et al. Regulatory review of novel therapeutics-comparison of three regulatory agencies. N Engl J Med 2012;366:2284-93
-
(2012)
N Engl J Med
, vol.366
, pp. 2284-2293
-
-
Downing, N.S.1
Aminawung, J.A.2
Shah, N.D.3
-
32
-
-
77950340063
-
Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design
-
Barnes PJ, Pocock SJ, Magnussen H, et al. Integrating indacaterol dose selection in a clinical study in COPD using an adaptive seamless design. Pulm Pharmacol Ther 2010;23:165-71
-
(2010)
Pulm Pharmacol Ther
, vol.23
, pp. 165-171
-
-
Barnes, P.J.1
Pocock, S.J.2
Magnussen, H.3
-
34
-
-
33646257465
-
Application of adaptive designs-a review
-
Bauer P, Einfalt J. Application of adaptive designs-a review. Biom J 2006;48:493-506
-
(2006)
Biom J
, vol.48
, pp. 493-506
-
-
Bauer, P.1
Einfalt, J.2
-
35
-
-
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, 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
-
36
-
-
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, 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
, pp. e0141104
-
-
Stevely, A.1
Dimairo, M.2
Todd, S.3
-
37
-
-
85024493564
-
A literature review of applied adaptive design methodology within the field of oncology in randomized controlled trials and a proposed extension to the CONSORT guidelines
-
Mistry P, Dunn JA, Marshall A. A literature review of applied adaptive design methodology within the field of oncology in randomized controlled trials and a proposed extension to the CONSORT guidelines. BMC Med Res Methodol 2017;17:108
-
(2017)
BMC Med Res Methodol
, vol.17
, pp. 108
-
-
Mistry, P.1
Dunn, J.A.2
Marshall, A.3
-
38
-
-
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, et al. 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
-
39
-
-
84863475669
-
On the independence of data monitoring committee in adaptive design clinical trials
-
Chow S-C, 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
-
41
-
-
78249249606
-
Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group
-
Gallo P, Anderson K, Chuang-Stein C, et al. Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group. J Biopharm Stat 2010;20:1115-24
-
(2010)
J Biopharm Stat
, vol.20
, pp. 1115-1124
-
-
Gallo, P.1
Anderson, K.2
Chuang-Stein, C.3
-
42
-
-
33748519263
-
A regulatory view on adaptive/ flexible clinical trial design
-
Hung HM, O'Neill RT, Wang SJ, et al. A regulatory view on adaptive/ flexible clinical trial design. Biom J 2006;48:565-73
-
(2006)
Biom J
, vol.48
, pp. 565-573
-
-
Hung, H.M.1
O'Neill, R.T.2
Wang, S.J.3
-
43
-
-
84865271518
-
Adaptive trial designs: A review of barriers and opportunities
-
Kairalla JA, Coffey CS, Thomann MA, et al. Adaptive trial designs: A review of barriers and opportunities. Trials 2012;13:145
-
(2012)
Trials
, vol.13
, pp. 145
-
-
Kairalla, J.A.1
Coffey, C.S.2
Thomann, M.A.3
-
44
-
-
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:e0149803-30
-
(2016)
PLoS One
, vol.11
, pp. e0149803-e0149830
-
-
Antoniou, M.1
Jorgensen, A.L.2
Kolamunnage-Dona, R.3
-
45
-
-
79955631914
-
Exploring the benefits of adaptive sequential designs in time-to-event endpoint settings
-
Emerson SC, Rudser KD, Emerson SS. Exploring the benefits of adaptive sequential designs in time-to-event endpoint settings. Stat Med 2011;30:1199-217
-
(2011)
Stat Med
, vol.30
, pp. 1199-1217
-
-
Emerson, S.C.1
Rudser, K.D.2
Emerson, S.S.3
|