-
1
-
-
52649109250
-
The impact of missing data and how it is handled on the rate of false-positive results in drug development
-
Barnes SA, Mallinckrodt CH, Lindborg SR, Carter KM. The impact of missing data and how it is handled on the rate of false-positive results in drug development. Pharm Stats 2008;7:215-25.
-
(2008)
Pharm Stats
, vol.7
, pp. 215-225
-
-
Barnes, S.A.1
Mallinckrodt, C.H.2
Lindborg, S.R.3
Carter, K.M.4
-
2
-
-
84878986011
-
Analyzing weight loss intervention studies with missing data: Which methods should be used
-
Batterham MJ, Tapsell LC, Charlton KE. Analyzing weight loss intervention studies with missing data: which methods should be used? Nutrition 2013;29:1024-9.
-
(2013)
Nutrition
, vol.29
, pp. 1024-1029
-
-
Batterham, M.J.1
Tapsell, L.C.2
Charlton, K.E.3
-
3
-
-
9444255722
-
Improving the quality of reporting of randomized controlled trials: The CONSORT statement
-
Begg C, Cho M, Eastwood, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials: The CONSORT statement. JAMA 1996;276:637-9.
-
(1996)
JAMA
, vol.276
, pp. 637-639
-
-
Begg, C.1
Cho, M.2
Eastwood3
Horton, R.4
Moher, D.5
Olkin, I.6
Pitkin, R.7
Rennie, D.8
Schulz, K.F.9
Simel, D.10
Stroup, D.F.11
-
5
-
-
84886307868
-
Interventional management of neuropathic pain: NeuPSIG recommendations
-
Dworkin RH, O'Connor AB, Kent J, Mackev, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke, H, Loser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. PAIN 2013;154:2249-2261.
-
(2013)
PAIN
, vol.154
, pp. 2249-2261
-
-
Dworkin, R.H.1
Oconnor, A.B.2
Kent, J.3
Mackev4
Raja, S.N.5
Stacey, B.R.6
Levy, R.M.7
Backonja, M.8
Baron, R.9
Harke, H.10
Loser, J.D.11
Treede, R.D.12
Turk, D.C.13
Wells, C.D.14
-
6
-
-
68949163883
-
Missing data in randomized clinical trials for weight loss: Scope of the problem, state of the field, and performance of statistical methods
-
Elobeid MA, Padilla MA, Mcvie T, Thomas O, Brock DW, Musser B, Lu K, Coffey CS, Desmond RA, St-Onge MP, Gadde KM, Heymsfield SB, Allison DB. Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods. PLoS One 2009;4:e6624.
-
(2009)
PLoS One
, vol.4
, pp. e6624
-
-
Elobeid, M.A.1
Padilla, M.A.2
McVie, T.3
Thomas, O.4
Brock, D.W.5
Musser, B.6
Lu, K.7
Coffey, C.S.8
Desmond, R.A.9
St-Onge, M.P.10
Gadde, K.M.11
Heymsfield, S.B.12
Allison, D.B.13
-
7
-
-
78649584235
-
-
European Medicines Agency. [accessed July 9, 2014]
-
European Medicines Agency. Guideline on missing data in confirmatory clinical trials; 2010. Available at: http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2010/09/WC500096793.pdf. [accessed July 9, 2014].
-
(2010)
Guideline on Missing Data in Confirmatory Clinical Trials
-
-
-
8
-
-
79551622288
-
Addressing missing data in clinical trials
-
Fleming TR. Addressing missing data in clinical trials. Ann Intern Med 2011;154:113-7.
-
(2011)
Ann Intern Med
, vol.154
, pp. 113-117
-
-
Fleming, T.R.1
-
9
-
-
84894265334
-
Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations
-
Gewandter JS, Smith SM, McKeown A, Burke LB, Hertz SH, Hunsinger M, Katz NP, Lin AH, McDermott MP, Rappaport BA, Williams MR, Turk DC, Dworkin RH. Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. PAIN 2014;155:461-6.
-
(2014)
PAIN
, vol.155
, pp. 461-466
-
-
Gewandter, J.S.1
Smith, S.M.2
McKeown, A.3
Burke, L.B.4
Hertz, S.H.5
Hunsinger, M.6
Katz, N.P.7
Lin, A.H.8
McDermott, M.P.9
Rappaport, B.A.10
Williams, M.R.11
Turk, D.C.12
Dworkin, R.H.13
-
10
-
-
0027265386
-
Some conceptual and statistical issues in analysis of longitudinal psychiatric data
-
Gibbons RD, Hedeker D, Waternaux D, Kraemer HC, Greenhouse JB, Shea MT, Imber SD, Sotsky SM, Watkins JT. Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Arch Gen Psych 1993;50:739-50.
-
(1993)
Arch Gen Psych
, vol.50
, pp. 739-750
-
-
Gibbons, R.D.1
Hedeker, D.2
Waternaux, D.3
Kraemer, H.C.4
Greenhouse, J.B.5
Shea, M.T.6
Imber, S.D.7
Sotsky, S.M.8
Watkins, J.T.9
-
11
-
-
70349231475
-
Intention-to-treat analysis and accounting for missing data in orthopedic randomized clinical trials
-
Herman A, Botser IB, Tenenbaum S, Chechick A. Intention-to-treat analysis and accounting for missing data in orthopedic randomized clinical trials. J Bone Joint Surg Am 2009;91:2137-43.
-
(2009)
J Bone Joint Surg Am
, vol.91
, pp. 2137-2143
-
-
Herman, A.1
Botser, I.B.2
Tenenbaum, S.3
Chechick, A.4
-
12
-
-
0027090197
-
Statistical handling of drop-outs in longitudinal clinical trials
-
Heyting A, Tolboom JTBM, Essers JGA. Statistical handling of drop-outs in longitudinal clinical trials. Stats Med 1992;11:2043-61.
-
(1992)
Stats Med
, vol.11
, pp. 2043-2061
-
-
Heyting, A.1
Tolboom, J.T.B.M.2
Essers, J.G.A.3
-
13
-
-
33645062724
-
Methodological issues in clinical trials of opioids for chronic pain
-
Katz NP. Methodological issues in clinical trials of opioids for chronic pain. Neurology 2005;65:S32-49.
-
(2005)
Neurology
, vol.65
, pp. S32-49
-
-
Katz, N.P.1
-
14
-
-
79952600996
-
Missing data handling in chronic pain trials
-
Kim Y. Missing data handling in chronic pain trials. J Biopharm Stat 2011;21:311-25.
-
(2011)
J Biopharm Stat
, vol.21
, pp. 311-325
-
-
Kim, Y.1
-
15
-
-
46449124620
-
Handling drop-out in longitudinal clincal trials: A comparison of the LOCF and MMRM approaches
-
Lane P. Handling drop-out in longitudinal clincal trials: a comparison of the LOCF and MMRM approaches. Pharm Stats 2007;7:93-106.
-
(2007)
Pharm Stats
, vol.7
, pp. 93-106
-
-
Lane, P.1
-
16
-
-
84870235168
-
The design and conduct of clinical trials to limit missing data
-
Little RJ, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Neaton JD, Shih W, Siegel JP, Stern H. The design and conduct of clinical trials to limit missing data. Stat Med 2012;31:3433-43.
-
(2012)
Stat Med
, vol.31
, pp. 3433-3443
-
-
Little, R.J.1
Cohen, M.L.2
Dickersin, K.3
Emerson, S.S.4
Farrar, J.T.5
Neaton, J.D.6
Shih, W.7
Siegel, J.P.8
Stern, H.9
-
17
-
-
84867183673
-
The prevention and treatment of missing data in clinical trials
-
Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, Frangakis C, Hogan JW, Molenberghs G, Murphy SA, Neaton JD, Rotnitzky A, Scharfstein D, Shih WJ, Siegel JP, Stern H. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012;367:1355-60.
-
(2012)
N Engl J Med
, vol.367
, pp. 1355-1360
-
-
Little, R.J.1
D'agostino, R.2
Cohen, M.L.3
Dickersin, K.4
Emerson, S.S.5
Farrar, J.T.6
Frangakis, C.7
Hogan, J.W.8
Molenberghs, G.9
Murphy, S.A.10
Neaton, J.D.11
Rotnitzky, A.12
Scharfstein, D.13
Shih, W.J.14
Siegel, J.P.15
Stern, H.16
-
20
-
-
0038147534
-
Assessing and interpreting treatment effects in longitudinal clinical trials with subject dropout
-
Mallinckrodt CH, Carroll RJ, Debrota DJ, Dube S, Molenberghs G, Potter WZ, Sanger TD, Tollefson GD. Assessing and interpreting treatment effects in longitudinal clinical trials with subject dropout. Biol Psychiatry 2003;53:754-60.
-
(2003)
Biol Psychiatry
, vol.53
, pp. 754-760
-
-
Mallinckrodt, C.H.1
Carroll, R.J.2
Debrota, D.J.3
Dube, S.4
Molenberghs, G.5
Potter, W.Z.6
Sanger, T.D.7
Tollefson, G.D.8
-
21
-
-
0035739468
-
Type i error rates from mixed-effects model repeated measures versus fixed effects analysis of variance with missing values imputed via last observation carried forward
-
Mallinckrodt CH, Clark WS, Stacy RD. Type I error rates from mixed-effects model repeated measures versus fixed effects analysis of variance with missing values imputed via last observation carried forward. Drug Inf J 2001;35:1215-25.
-
(2001)
Drug Inf J
, vol.35
, pp. 1215-1225
-
-
Mallinckrodt, C.H.1
Clark, W.S.2
Stacy, R.D.3
-
23
-
-
84855942037
-
Estimate at your peril: Imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses
-
Moore RA, Straube S, Eccleston C, Derry S, Aldington D, Wiffen P, Bell RF, Hamunen K, Phillips C, McQuay H. Estimate at your peril: imputation methods for patient withdrawal can bias efficacy outcomes in chronic pain trials using responder analyses. PAIN 2012;153:265-8.
-
(2012)
PAIN
, vol.153
, pp. 265-268
-
-
Moore, R.A.1
Straube, S.2
Eccleston, C.3
Derry, S.4
Aldington, D.5
Wiffen, P.6
Bell, R.F.7
Hamunen, K.8
Phillips, C.9
McQuay, H.10
-
24
-
-
79952576381
-
-
National Research Council The National Academies Press. [accessed July 9, 2014]
-
National Research Council. The prevention and treatment of missing data in clinical trials. The National Academies Press; 2010. Available at: http:// www.nap.edu/catalog/12955.html. [accessed July 9, 2014].
-
(2010)
The Prevention and Treatment of Missing Data in Clinical Trials
-
-
-
25
-
-
38349175953
-
Long-term opioid therapy for chonic noncancer pain: A systematic review and meta-analysis of efficacy and safety
-
Noble M, Tregear SJ, Treadwell JR, Schoelles K. Long-term opioid therapy for chonic noncancer pain: a systematic review and meta-analysis of efficacy and safety. J Pain Symptom Manage 20098;35:214-228.
-
(2009)
J Pain Symptom Manage
, vol.35
, pp. 214-228
-
-
Noble, M.1
Tregear, S.J.2
Treadwell, J.R.3
Schoelles, K.4
-
26
-
-
84857231864
-
The prevention and treatment of missing data in clinical trials: An FDA perspective on the importance of dealing with it
-
O'Neill RT, Temple R. The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it. Clin Pharmacol Ther 2012;91:550-4.
-
(2012)
Clin Pharmacol Ther
, vol.91
, pp. 550-554
-
-
O'neill, R.T.1
Temple, R.2
-
27
-
-
77953395873
-
CONSORT, Statement: Updated guidelines for reporting parallel group randomized trials
-
for the CONSORT group
-
Schulz KF, Altman DG, Moher D, for the CONSORT group. CONSORT, Statement: Updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010;2010:726-32.
-
(2010)
Ann Intern Med
, vol.2010
, pp. 726-732
-
-
Schulz, K.F.1
Altman, D.G.2
Moher, D.3
-
28
-
-
79953209006
-
MMRM versus MI in dealing with missing data-a comparison based on 25 NDA data sets
-
Siddiqui O. MMRM versus MI in dealing with missing data-a comparison based on 25 NDA data sets. J Biopharm Stat 2011;21:423-36.
-
(2011)
J Biopharm Stat
, vol.21
, pp. 423-436
-
-
Siddiqui, O.1
-
29
-
-
0031729840
-
A comparison of the random-effects pattern-mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts
-
Siddiqui O, Ali MW. A comparison of the random-effects pattern-mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts. J Biopharm Stat 1998;8:545-63.
-
(1998)
J Biopharm Stat
, vol.8
, pp. 545-563
-
-
Siddiqui, O.1
Ali, M.W.2
-
30
-
-
60749108941
-
MMRM vs. LOCF: A comprehensive comparison based on simulation study and 25 NDA datasets
-
Siddiqui O, Hung HMJ, O'Neill R. MMRM vs. LOCF: a comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stats 2009;19:227-246.
-
(2009)
J Biopharm Stats
, vol.19
, pp. 227-246
-
-
Siddiqui, O.1
Hung, H.M.J.2
O'neill, R.3
-
31
-
-
85067732641
-
-
U.S. Department of Health and Human Services, Food and Drug Administration. [accessed February 9, 2014]
-
U.S. Department of Health and Human Services, Food and Drug Administration. Analgesic indications: developing drug and biological products: draft guidance; 2014. Available at: http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM384691.pdf. [accessed February 9, 2014].
-
(2014)
Analgesic Indications: Developing Drug and Biological Products: Draft Guidance
-
-
-
32
-
-
84880288284
-
Reporting and handling missing values in clinical studies in intensive care units
-
Vesin A, Azoulay E, Ruckly S, Vignoud L, Rusinova K, Benoit D, Soares M, Azeivedo-Maia P, Abroug F, Benbenishty J, Timsit JF. Reporting and handling missing values in clinical studies in intensive care units. Intensive Care Med 2013;39:1396-404.
-
(2013)
Intensive Care Med
, vol.39
, pp. 1396-1404
-
-
Vesin, A.1
Azoulay, E.2
Ruckly, S.3
Vignoud, L.4
Rusinova, K.5
Benoit, D.6
Soares, M.7
Azeivedo-Maia, P.8
Abroug, F.9
Benbenishty, J.10
Timsit, J.F.11
-
33
-
-
75749136125
-
Missing inaction: Preventing missing outcome data in randomized clinical trials
-
Wittes J. Missing inaction: preventing missing outcome data in randomized clinical trials. J Biopharm Stat 2009;19:957-68.
-
(2009)
J Biopharm Stat
, vol.19
, pp. 957-968
-
-
Wittes, J.1
|