-
1
-
-
17844372209
-
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa Statement (part 1)
-
for the Ottawa Group
-
Krleža-Jeric K, Chan A-W, Dickersin K, et al. for the Ottawa Group. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa Statement (part 1). BMJ 2005;330:956-8
-
(2005)
BMJ
, vol.330
, pp. 956-958
-
-
Krleža-Jeric, K.1
Chan, A.-W.2
Dickersin, K.3
-
2
-
-
0003491133
-
-
World Medical Association. Adopted by the 59th WMA General Assembly, Seoul, Korea, October. [Last Accessed 3 June 2013]
-
World Medical Association. Declaration of Helsinki 2008 update - ethical principles for medical research involving human subjects. Adopted by the 59th WMA General Assembly, Seoul, Korea, October 2008. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html [Last Accessed 3 June 2013]
-
(2008)
Declaration of Helsinki 2008 Update - Ethical Principles for Medical Research Involving Human Subjects
-
-
-
3
-
-
0028128360
-
Rationale for systematic reviews
-
Mulrow CD. Rationale for systematic reviews. BMJ 1994;309:597-9
-
(1994)
BMJ
, vol.309
, pp. 597-599
-
-
Mulrow, C.D.1
-
5
-
-
0025099275
-
Underreporting research is scientific misconduct
-
Chalmers I. Underreporting research is scientific misconduct. JAMA 1990;263:1405-8
-
(1990)
JAMA
, vol.263
, pp. 1405-1408
-
-
Chalmers, I.1
-
6
-
-
0023008125
-
Publication bias: The case for an international registry of clinical trials
-
Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncol 1986;4:1529-41
-
(1986)
J Clin Oncol
, vol.4
, pp. 1529-1541
-
-
Simes, R.J.1
-
7
-
-
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
-
(2008)
PLoS Med
, vol.5
-
-
Lee, K.1
Bacchetti, P.2
Sim, I.3
-
8
-
-
56749166123
-
Reporting bias in drug trials submitted to the Food and Drug Administration: Review of publication and presentation
-
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
-
(2008)
PLoS Med
, vol.5
-
-
Rising, K.1
Bacchetti, P.2
Bero, L.3
-
9
-
-
52649129348
-
Systematic review of the empirical evidence of study publication bias and outcome reporting bias
-
Dwan K, Altman DG, Arnaiz JA, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One 2008;3:e3081
-
(2008)
PLoS One
, vol.3
-
-
Dwan, K.1
Altman, D.G.2
Arnaiz, J.A.3
-
10
-
-
72849132173
-
Dissemination and publication of research findings: An updated review of related biases
-
Song F, Parekh S, Hooper L, et al. Dissemination and publication of research findings: an updated review of related biases. Health Technol Assess 2010;14:1-220
-
(2010)
Health Technol Assess
, vol.14
, pp. 1-220
-
-
Song, F.1
Parekh, S.2
Hooper, L.3
-
11
-
-
84873852239
-
Getting more generous with the truth; Clinical trial reporting in 2013 and beyond
-
The PLOS Medicine Editors
-
The PLOS Medicine Editors. Getting more generous with the truth; clinical trial reporting in 2013 and beyond. PLoS Med 2013;10:e1001379
-
(2013)
PLoS Med
, vol.10
-
-
-
12
-
-
84879331768
-
Restoring the integrity of the clinical trials evidence base
-
Loder E, Godlee F, Barbour V, Winker M. Restoring the integrity of the clinical trials evidence base. BMJ 2013;346:f3601
-
(2013)
BMJ
, vol.346
-
-
Loder, E.1
Godlee, F.2
Barbour, V.3
Winker, M.4
-
13
-
-
84896723760
-
-
Food and Drug Administration. of Public Law No 105-115
-
Food and Drug Administration. Modernization Act of 1997. Public Law No 105-115
-
(1997)
Modernization Act
-
-
-
14
-
-
84896704759
-
-
Food and Drug Administration. Public Law No 110-85
-
Food and Drug Administration. Amendments Act of 2007. Public Law No 110-85
-
(2007)
Amendments Act
-
-
-
15
-
-
0003177157
-
-
Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
-
Directive 2001/20/EC of the European Parliament and the Council of 4 Apr 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Community 2001;L121:34-44
-
(2001)
Official J Eur Community
, vol.L121
, pp. 34-44
-
-
-
16
-
-
84896737610
-
Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
-
Commission Guideline
-
Commission Guideline. Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. Official J Eur Union 2012;C302:7-10
-
(2012)
Official J Eur Union
, vol.C302
, pp. 7-10
-
-
-
19
-
-
84896712626
-
-
European Medicines Agency. [Last accessed 16 August 2013]
-
European Medicines Agency. (2013) Policy on proactive publication of clinical-trial data. Available at: http://www.ema.europa.eu/ema/index.jsp?-curl= pages/news-and-events/news/2013/06/news-detail-001825.jsp&mid= WC0b01ac058004d5c1 [Last accessed 16 August 2013]
-
(2013)
Policy on Proactive Publication of Clinical-trial Data
-
-
-
20
-
-
4644245257
-
Clinical trial registration: A statement from the International Committee of Medical Journal Editors
-
De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. CMAJ 2004;171:606-7
-
(2004)
CMAJ
, vol.171
, pp. 606-607
-
-
De Angelis, C.1
Drazen, J.M.2
Frizelle, F.A.3
-
22
-
-
84896725883
-
-
IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Updated 10 November [Last accessed 3 June 2013]
-
IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Updated 10 November 2009. Available at: http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/EN/ November-10-2009-Updated-Joint-Position-on-the-Disclosure-of-Clinical-Trial- Information-via-Clinical-Trial-Registries-and-Databases.pdf [Last accessed 3 June 2013]
-
(2009)
-
-
-
23
-
-
84896734744
-
-
IFPMA Joint Position on the Publication of Clinical Trial Results. 10 June [Last accessed 3 June 2013]
-
IFPMA Joint Position on the Publication of Clinical Trial Results. 10 June 2010. Available at: http://clinicaltrials.ifpma.org/clinicaltrials/ fileadmin/files/pdfs/20100610-Joint-Position-Publication-10Jun2010.pdf [Last accessed 3 June 2013]
-
(2010)
-
-
-
24
-
-
69849092717
-
Comparison of registered and published primary outcomes in randomized controlled trials
-
Mathieu S, Boutron I, Moher D, et al. Comparison of registered and published primary outcomes in randomized controlled trials. JAMA 2009;302: 977-84
-
(2009)
JAMA
, vol.302
, pp. 977-984
-
-
Mathieu, S.1
Boutron, I.2
Moher, D.3
-
25
-
-
77955506490
-
Outcome reporting among drug trials registered in ClinicalTrials.Gov
-
Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med 2010;153:158-66
-
(2010)
Ann Intern Med
, vol.153
, pp. 158-166
-
-
Bourgeois, F.T.1
Murthy, S.2
Mandl, K.D.3
-
26
-
-
70349636711
-
Trial publication after registration in ClinicalTrials.Gov: A cross-sectional analysis
-
Ross JS, Mulvey GK, Hines EM, et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009;6:e1000144
-
(2009)
PLoS Med
, vol.6
-
-
Ross, J.S.1
Mulvey, G.K.2
Hines, E.M.3
-
27
-
-
79952267051
-
The ClinicalTrials.Gov results databaseupdate and key issues
-
Zarin DA, Tse T, Williams RJ, et al. The ClinicalTrials.gov results databaseupdate and key issues. N Engl J Med 2011;364:852-60
-
(2011)
N Engl J Med
, vol.364
, pp. 852-860
-
-
Zarin, D.A.1
Tse, T.2
Williams, R.J.3
-
28
-
-
84855661185
-
Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.Gov
-
Law MR, Kawasumi Y, Morgan SG. Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. Health Aff (Milwood) 2011;30:2338-45
-
(2011)
Health Aff (Milwood)
, vol.30
, pp. 2338-2345
-
-
Law, M.R.1
Kawasumi, Y.2
Morgan, S.G.3
-
29
-
-
84865972046
-
How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the ClinicalTrials.gov database
-
Gill CJ. How often do US-based human subjects research studies register on time, and how often do they post their results? A statistical analysis of the ClinicalTrials.gov database. BMJ Open 2012;2:e001186
-
(2012)
BMJ Open
, vol.2
-
-
Gill, C.J.1
-
30
-
-
84859005251
-
Compliance with mandatory reporting of clinical trial results on ClinicalTrials.Gov: Cross-sectional study
-
Prayle AP, Hurley MN, Smith AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross-sectional study. BMJ 2012;344:d7373
-
(2012)
BMJ
, vol.344
-
-
Prayle, A.P.1
Hurley, M.N.2
Smith, A.R.3
-
31
-
-
84873046730
-
FDA disagrees with BMJ study that found clinical trials were not being reported
-
Hawkes N. FDA disagrees with BMJ study that found clinical trials were not being reported. BMJ 2012;344:e3277
-
(2012)
BMJ
, vol.344
-
-
Hawkes, N.1
-
32
-
-
84896703937
-
FDA says study overestimated non-compliance with datareporting laws
-
10.1038/nature.2012.10549
-
Wadman M. FDA says study overestimated non-compliance with datareporting laws. Nature 2012;10.1038/nature.2012.10549
-
(2012)
Nature
-
-
Wadman, M.1
-
33
-
-
84896698998
-
-
Commons Select Committee. Committee to inquire into clinical trials and disclosure of data. 13 December [Last accessed 3 June 2013]
-
Commons Select Committee. Committee to inquire into clinical trials and disclosure of data. 13 December 2012. Available at: http://www.parliament.uk/ business/committees/committees-a-z/commons-select/scienceand-technology- committee/news/121213-clinical-trials-inquiry-announced/ [Last accessed 3 June 2013]
-
(2012)
-
-
-
34
-
-
84878443720
-
Publication rate for funded studies from a major UK health research funder: A cohort study
-
Turner S, Wright D, Maeso R, et al. Publication rate for funded studies from a major UK health research funder: a cohort study. BMJ Open 2013;3:e002521
-
(2013)
BMJ Open
, vol.3
-
-
Turner, S.1
Wright, D.2
Maeso, R.3
-
35
-
-
84896710272
-
-
ABPI Clinical Trial Disclosure Toolkit. [Last accessed 16 Aug 2013]
-
ABPI Clinical Trial Disclosure Toolkit. 2013. Available at: http://www.abpi.org. uk/our-work/mandi/Pages/clinical-trial-transparency.aspx [Last accessed 16 Aug 2013]
-
(2013)
-
-
-
36
-
-
78149235437
-
-
EU Clinical Trial Register. [Last accessed 3 June 2013]
-
EU Clinical Trial Register. 2013 Frequently Asked Questions. Available at: http://www.clinicaltrialsregister.eu/doc/EU-CTR-FAQ.pdf [Last accessed 3 June 2013]
-
(2013)
Frequently Asked Questions
-
-
-
37
-
-
84879977752
-
Precision and negative predictive value of links between ClinicalTrials.Gov and pubmed
-
Huser V, Cimino JJ. Precision and negative predictive value of links between ClinicalTrials.gov and PubMed. AMIA Annu Symp Proc 2012;2012:400-8
-
(2012)
AMIA Annu Symp Proc
, vol.2012
, pp. 400-408
-
-
Huser, V.1
Cimino, J.J.2
|