-
1
-
-
38349049478
-
Selective publication of antidepressant trials and its influence on apparent efficacy
-
Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 2008;358:252-60. doi:10.1056/NEJMsa065779
-
(2008)
N Engl J Med
, vol.358
, pp. 252-260
-
-
Turner, E.H.1
Matthews, A.M.2
Linardatos, E.3
Tell, R.A.4
Rosenthal, R.5
-
2
-
-
56749166123
-
Reporting bias in drug trials submitted to the Food and Drug Administration: Review of publication and presentation
-
discussion e217
-
Rising K, Bacchetti P, Bero L. Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. PLoS Med 2008;5:e217, discussion e217. doi:10.1371/journal.pmed.0050217
-
(2008)
PLoS Med
, vol.5
, pp. e217
-
-
Rising, K.1
Bacchetti, P.2
Bero, L.3
-
3
-
-
54749152234
-
Publication of clinical trials supporting successful new drug applications: A literature analysis
-
Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med 2008;5:e191. doi:10.1371/journal.pmed.0050191
-
(2008)
PLoS Med
, vol.5
, pp. e191
-
-
Lee, K.1
Bacchetti, P.2
Sim, I.3
-
4
-
-
84858996695
-
Effect of reporting bias on meta-analyses of drug trials: Reanalysis of meta-analyses
-
Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ 2012;344:d7202. doi:10.1136/bmj.d7202
-
(2012)
BMJ
, vol.344
, pp. d7202
-
-
Hart, B.1
Lundh, A.2
Bero, L.3
-
5
-
-
0031715866
-
Quinine for nocturnal leg cramps: A meta-analysis including unpublished data
-
Man-Son-Hing M, Wells G, Lau A. Quinine for nocturnal leg cramps: a meta-analysis including unpublished data. J Gen Intern Med 1998;13:600-6. doi:10.1046/j.1525-1497.1998.00182.x
-
(1998)
J Gen Intern Med
, vol.13
, pp. 600-606
-
-
Man-Son-Hing, M.1
Wells, G.2
Lau, A.3
-
6
-
-
84883454261
-
US Food and Drug Administration documents can provide unpublished evidence relevant to systematic reviews
-
McDonagh MS, Peterson K, Balshem H, Helfand M. US Food and Drug Administration documents can provide unpublished evidence relevant to systematic reviews. J Clin Epidemiol 2013;66:1071-81. doi:10.1016/j.jclinepi.2013.05.006
-
(2013)
J Clin Epidemiol
, vol.66
, pp. 1071-1081
-
-
McDonagh, M.S.1
Peterson, K.2
Balshem, H.3
Helfand, M.4
-
7
-
-
0037267022
-
How useful are unpublished data from the Food and Drug Administration in metaanalysis?
-
Southern California Evidence-Based Practice Center
-
MacLean CH, Morton SC, Ofman JJ, Roth EA, Shekelle PG, Southern California Evidence-Based Practice Center. How useful are unpublished data from the Food and Drug Administration in metaanalysis? J Clin Epidemiol 2003;56:44-51. doi:10.1016/S0895-4356(02)00520-6
-
(2003)
J Clin Epidemiol
, vol.56
, pp. 44-51
-
-
MacLean, C.H.1
Morton, S.C.2
Ofman, J.J.3
Roth, E.A.4
Shekelle, P.G.5
-
8
-
-
84990173527
-
Value and usability of unpublished data sources for systematic reviews and network meta-analyses
-
Halfpenny NJA, Quigley JM, Thompson JC, Scott DA. Value and usability of unpublished data sources for systematic reviews and network meta-analyses. Evid Based Med 2016;21:208-13. doi:10.1136/ebmed-2016-110494
-
(2016)
Evid Based Med
, vol.21
, pp. 208-213
-
-
Nja, H.1
Quigley, J.M.2
Thompson, J.C.3
Scott, D.A.4
-
10
-
-
84878739419
-
Searching for unpublished data for Cochrane reviews: Cross sectional study
-
Schroll JB, Bero L, Gøtzsche PC. Searching for unpublished data for Cochrane reviews: cross sectional study. BMJ 2013;346:f2231. doi:10.1136/bmj.f2231
-
(2013)
BMJ
, vol.346
, pp. f2231
-
-
Schroll, J.B.1
Bero, L.2
Gøtzsche, P.C.3
-
11
-
-
84977599952
-
Most systematic reviews of adverse effects did not include unpublished data
-
Golder S, Loke YK, Wright K, Sterrantino C. Most systematic reviews of adverse effects did not include unpublished data. J Clin Epidemiol 2016;77:125-33. doi:10.1016/j.jclinepi.2016.05.003
-
(2016)
J Clin Epidemiol
, vol.77
, pp. 125-133
-
-
Golder, S.1
Loke, Y.K.2
Wright, K.3
Sterrantino, C.4
-
12
-
-
67650106430
-
The need for improved access to FDA reviews
-
O'Connor AB. The need for improved access to FDA reviews. JAMA 2009;302:191-3. doi:10.1001/jama.2009.973
-
(2009)
JAMA
, vol.302
, pp. 191-193
-
-
O'Connor, A.B.1
-
13
-
-
84888778352
-
How to access and process FDA drug approval packages for use in research
-
Turner EH. How to access and process FDA drug approval packages for use in research. BMJ 2013;347:f5992. doi:10.1136/bmj.f5992
-
(2013)
BMJ
, vol.347
, pp. f5992
-
-
Turner, E.H.1
-
14
-
-
84886558979
-
Strategies for obtaining unpublished drug trial data: A qualitative interview study
-
Wolfe N, Gøtzsche PC, Bero L. Strategies for obtaining unpublished drug trial data: a qualitative interview study. Syst Rev 2013;2:31. doi:10.1186/2046-4053-2-31
-
(2013)
Syst Rev
, vol.2
, pp. 31
-
-
Wolfe, N.1
Gøtzsche, P.C.2
Bero, L.3
-
15
-
-
84916208957
-
The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports
-
Schroll JB, Abdel-Sattar M, Bero L. The Food and Drug Administration reports provided more data but were more difficult to use than the European Medicines Agency reports. J Clin Epidemiol 2015;68:102-7. doi:10.1016/j.jclinepi.2014.06.019
-
(2015)
J Clin Epidemiol
, vol.68
, pp. 102-107
-
-
Schroll, J.B.1
Abdel-Sattar, M.2
Bero, L.3
-
16
-
-
85012902279
-
You can now search FDA approval documents easily at fda.opentrials.net
-
Turner EOpenTrials team
-
Goldacre B, Turner EOpenTrials team. You can now search FDA approval documents easily at fda.opentrials.net. BMJ 2017;356:j677. doi:10.1136/bmj.j677
-
(2017)
BMJ
, vol.356
, pp. j677
-
-
Goldacre, B.1
-
17
-
-
84979663025
-
Transparency in drug regulation: Public assessment reports in Europe and Australia
-
Papathanasiou P, Brassart L, Blake P, et al. Transparency in drug regulation: public assessment reports in Europe and Australia. Drug Discov Today 2016;21:1806-13. doi:10.1016/j.drudis.2016.06.025
-
(2016)
Drug Discov Today
, vol.21
, pp. 1806-1813
-
-
Papathanasiou, P.1
Brassart, L.2
Blake, P.3
-
29
-
-
85049825355
-
-
US Food and Drug Administration
-
US Food and Drug Administration. Good review practice: Statistical review template. 2012. www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm313814.pdf.
-
(2012)
Good Review Practice: Statistical Review Template
-
-
-
30
-
-
85049838856
-
-
US Food and Drug Administration
-
US Food and Drug Administration. Regulatory information: Freedom of information. 2018. www.fda.gov/RegulatoryInformation/FOI/default.htm.
-
(2018)
Regulatory Information: Freedom of Information
-
-
-
31
-
-
34547450763
-
Practical methods for incorporating summary time-to-event data into meta-analysis
-
Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 2007;8:16. doi:10.1186/1745-6215-8-16
-
(2007)
Trials
, vol.8
, pp. 16
-
-
Tierney, J.F.1
Stewart, L.A.2
Ghersi, D.3
Burdett, S.4
Sydes, M.R.5
-
32
-
-
0032583387
-
Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints
-
Parmar MKB, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med 1998;17:2815-34. doi:10.1002/(SICI)1097-0258(19981230)17:242815::AID-SIM1103.0.CO;2-8
-
(1998)
Stat Med
, vol.17
, pp. 2815-2834
-
-
Mkb, P.1
Torri, V.2
Stewart, L.3
|