-
1
-
-
84982193348
-
Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals
-
Dec 2014. Available at:. Accessed on 3 July
-
International Committee of Medical Journal Editors. Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. Dec 2014. Available at: www.icmje.org/icmje-recommendations.pdf. Accessed on 3 July 2015.
-
(2015)
-
-
-
2
-
-
84939565016
-
-
Available at:. Accessed on 3 July
-
World Health Organization. International clinical trials registry platform (ICTRP). Available at: www.who.int/ictrp/en/. Accessed on 3 July 2015.
-
(2015)
-
-
-
3
-
-
84939572151
-
-
Accessed on 3 July
-
Food and Drug Administration Amendments Act of 2007. Public Law 110-85 www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf. Accessed on 3 July 2015.
-
(2015)
Public Law 110-85
-
-
-
4
-
-
84939567662
-
Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the 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
-
May 2001. Available at:. Accessed on 3 July
-
European Commission. Directive 2001/20/EC of the European parliament and of the council of 4 April 2001 on the approximation of the 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. May 2001. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Accessed on 3 July 2015.
-
(2015)
-
-
-
5
-
-
84939177854
-
Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014
-
Available at:. Accessed on 3 July
-
European Medicines Agency. Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014. Available at: www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/06/news_detail_002127.jsp&mid=WC0b01ac058004d5c1. Accessed on 3 July 2015.
-
(2015)
-
-
-
6
-
-
33646489046
-
Research protocols: waiving confidentiality for the greater good
-
Chan AW, Upshur R, Singh JA, Ghersi D, Chapuis F, Altman DG. Research protocols: waiving confidentiality for the greater good. BMJ 2006;332:1086-9.
-
(2006)
BMJ
, vol.332
, pp. 1086-1089
-
-
Chan, A.W.1
Upshur, R.2
Singh, J.A.3
Ghersi, D.4
Chapuis, F.5
Altman, D.G.6
-
7
-
-
64049095051
-
Towards agreement on best practice for publishing raw clinical trial data
-
Hrynaszkiewicz I, Altman DG. Towards agreement on best practice for publishing raw clinical trial data. Trials 2009;10:17.
-
(2009)
Trials
, vol.10
, pp. 17
-
-
Hrynaszkiewicz, I.1
Altman, D.G.2
-
8
-
-
84907014634
-
Reanalyses of randomized clinical trial data
-
Ebrahim S, Sohani ZN, Montoya L, Agarwal A, Thorlund K, Mills EJ et al. Reanalyses of randomized clinical trial data. JAMA 2014;312:1024-32.
-
(2014)
JAMA
, vol.312
, pp. 1024-1032
-
-
Ebrahim, S.1
Sohani, Z.N.2
Montoya, L.3
Agarwal, A.4
Thorlund, K.5
Mills, E.J.6
-
9
-
-
84907616472
-
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
-
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM et al. Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey. Trials 2014;15:384.
-
(2014)
Trials
, vol.15
, pp. 384
-
-
Rathi, V.K.1
Strait, K.M.2
Gross, C.P.3
Hrynaszkiewicz, I.4
Joffe, S.5
Krumholz, H.M.6
-
10
-
-
84939572670
-
Public Health Research Data Forum
-
Available at:. Accessed on 3 July
-
Wellcome Trust. Public Health Research Data Forum. Available at: http://www.wellcome.ac.uk/About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/WTDV030689.htm. Accessed on 3 July 2015.
-
(2015)
-
-
-
11
-
-
84939563559
-
-
Accessed on 3 July
-
Clinical Study Data Request.com https://www.clinicalstudydatarequest.com/. Accessed on 3 July 2015.
-
(2015)
-
-
-
12
-
-
84925302834
-
European Medicines Agency policy on publication of clinical data for medicinal products for human use
-
2 October 2014. EMA/240810/2013. Policy/0070. Available at:. Accessed on 3 July 2015.
-
European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use. 2 October 2014. EMA/240810/2013. Policy/0070. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf. Accessed on 3 July 2015.
-
-
-
-
13
-
-
84939566148
-
PLOS Data policy summary
-
Available at:. Accessed on 3 July
-
PLOS Data policy summary. Available at: http://blogs.lshtm.ac.uk/rdmss/files/2014/03/PLOS-Data-Policy-Summary.pdf. Accessed on 3 July 2015.
-
(2015)
-
-
-
14
-
-
84869835629
-
The new BMJ policy on sharing data from drug and device trials
-
Godlee F, Groves T. The new BMJ policy on sharing data from drug and device trials. BMJ 2012;345:e7888.
-
(2012)
BMJ
, vol.345
, pp. e7888
-
-
Godlee, F.1
Groves, T.2
-
15
-
-
84879803885
-
Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review
-
For the Reporting Bias Group
-
Dwan K, Gamble C, Williamson PR, Kirkham JJ, for the Reporting Bias Group. Systematic review of the empirical evidence of study publication bias and outcome reporting bias - an updated review. PLoS ONE 2013;8:e66844.
-
(2013)
PLoS ONE
, vol.8
-
-
Dwan, K.1
Gamble, C.2
Williamson, P.R.3
Kirkham, J.J.4
-
16
-
-
84915803004
-
Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions
-
Page MJ, McKenzie JE, Kirkham J et al. Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. Cochrane Database Syst Rev 2014;10:MR000035.
-
(2014)
Cochrane Database Syst Rev
, vol.10
-
-
Page, M.J.1
McKenzie, J.E.2
Kirkham, J.3
-
17
-
-
79952266571
-
Comparison of protocols and registry entries to published reports for randomised controlled trials
-
Dwan K, Altman DG, Cresswell L et al. Comparison of protocols and registry entries to published reports for randomised controlled trials. Cochrane Database Syst Rev 2011;1:MR000031.
-
(2011)
Cochrane Database Syst Rev
, vol.1
-
-
Dwan, K.1
Altman, D.G.2
Cresswell, L.3
-
18
-
-
84935020062
-
Improving transparency of clinical trials
-
Dal-Ré R. Improving transparency of clinical trials. Trends Pharmacol Sci 2015;36:323-5.
-
(2015)
Trends Pharmacol Sci
, vol.36
, pp. 323-325
-
-
Dal-Ré, R.1
-
19
-
-
84915757902
-
Clinical trials: what a waste (editorial)
-
Ioannidis JPA. Clinical trials: what a waste (editorial). BMJ 2014;349:g7089.
-
(2014)
BMJ
, vol.349
, pp. g7089
-
-
Ioannidis, J.P.A.1
-
20
-
-
84892614609
-
Increasing value and reducing waste: addressing inaccessible research
-
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014;383:257-66.
-
(2014)
Lancet
, vol.383
, pp. 257-266
-
-
Chan, A.W.1
Song, F.2
Vickers, A.3
Jefferson, T.4
Dickersin, K.5
Gøtzsche, P.C.6
-
21
-
-
84908261004
-
How good is 'evidence' from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?
-
Naci H, Ioannidis JP. How good is 'evidence' from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs? Annu Rev Pharmacol Toxicol 2015;55:169-89.
-
(2015)
Annu Rev Pharmacol Toxicol
, vol.55
, pp. 169-189
-
-
Naci, H.1
Ioannidis, J.P.2
-
22
-
-
84896759357
-
Reporting of results in ClinicalTrials.gov and high-impact journals
-
Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA 2014;311:1063-5.
-
(2014)
JAMA
, vol.311
, pp. 1063-1065
-
-
Becker, J.E.1
Krumholz, H.M.2
Ben-Josef, G.3
Ross, J.S.4
-
23
-
-
84939570299
-
Committee on publication ethics
-
March 2011. Available at:. Accessed on 3 July
-
COPE. Committee on publication ethics. Code of conduct and best practice guidelines for journal editors. March 2011. Available at: http://publicationethics.org/resources/code-conduct. Accessed on 3 July 2015.
-
(2015)
Code of conduct and best practice guidelines for journal editors
-
-
-
24
-
-
33846588681
-
Recommendations on publication ethics policies for medical journals
-
Available at:. Accessed on 3 July
-
WAME Publication Ethics Committee. Recommendations on publication ethics policies for medical journals. World Association of Medical Editors. Available at: http://www.wame.org/about/recommendations-on-publication-ethics-policie. Accessed on 3 July 2015.
-
(2015)
World Association of Medical Editors
-
-
-
25
-
-
84882432922
-
Declaration of transparency for each research article
-
Altman DG, Moher D. Declaration of transparency for each research article. BMJ 2013;347:f4796.
-
(2013)
BMJ
, vol.347
, pp. f4796
-
-
Altman, D.G.1
Moher, D.2
-
26
-
-
84896487400
-
Time to ensure that clinical trial appropriate results are actually published
-
Dal-Re R, Caplan A. Time to ensure that clinical trial appropriate results are actually published. Eur J Clin Pharmacol 2014;70:491-3.
-
(2014)
Eur J Clin Pharmacol
, vol.70
, pp. 491-493
-
-
Dal-Re, R.1
Caplan, A.2
-
27
-
-
84876047415
-
Use of trial register information during the peer review process
-
Mathieu S, Chan A-W, Ravaud P. Use of trial register information during the peer review process. PLoS ONE 2013;8:e59910.
-
(2013)
PLoS ONE
, vol.8
, pp. e59910
-
-
Mathieu, S.1
Chan, A.-W.2
Ravaud, P.3
-
28
-
-
84897566259
-
The quality of registration of clinical trials: still a problem
-
Viergever RF, Karam G, Reis A et al. The quality of registration of clinical trials: still a problem. PLoS ONE 2014;9:e84727.
-
(2014)
PLoS ONE
, vol.9
, pp. e84727
-
-
Viergever, R.F.1
Karam, G.2
Reis, A.3
-
29
-
-
84879907736
-
Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration
-
Huser V, Cimino JJ. Evaluating adherence to the International Committee of Medical Journal Editors' policy of mandatory, timely clinical trial registration. J Am Med Inform Assoc 2013;20(e1):e169-74.
-
(2013)
J Am Med Inform Assoc
, vol.20
, Issue.E1
, pp. e169-e174
-
-
Huser, V.1
Cimino, J.J.2
-
30
-
-
34249805427
-
When and how can endpoints be changed after initiation of a randomized clinical trial?
-
Evans S. When and how can endpoints be changed after initiation of a randomized clinical trial? PLoS Clin Trials 2007;2:e18.
-
(2007)
PLoS Clin Trials
, vol.2
, pp. e18
-
-
Evans, S.1
-
31
-
-
84923595326
-
Sharing of Clinical Trial Data: Maximizing benefits, minimizing risk
-
14 January 2015. Available at:. Accessed on 3 July
-
Institute of Medicine. Sharing of Clinical Trial Data: Maximizing benefits, minimizing risk. 14 January 2015. Available at: https://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx. Accessed on 3 July 2015.
-
(2015)
-
-
-
32
-
-
84920598363
-
The proposed rule for US clinical trial registration and results submission
-
Zarin DA, Tse T, Sheehan J. The proposed rule for US clinical trial registration and results submission. N Engl J Med 2015;372:174-80.
-
(2015)
N Engl J Med
, vol.372
, pp. 174-180
-
-
Zarin, D.A.1
Tse, T.2
Sheehan, J.3
-
33
-
-
84926363380
-
A call to improve the transparency of trials of non-regulated interventions
-
Dal-Re R, Ioannidis JPA, Bracken MB. A call to improve the transparency of trials of non-regulated interventions. BMJ 2015;350:h1323.
-
(2015)
BMJ
, vol.350
, pp. h1323
-
-
Dal-Re, R.1
Ioannidis, J.P.A.2
Bracken, M.B.3
-
34
-
-
84939562445
-
WHO Statement on Public Disclosure of Clinical Trial Results
-
Available at:. Accessed on 3 July 2015.
-
World Health Organization. WHO Statement on Public Disclosure of Clinical Trial Results. Available at: http://www.who.int/ictrp/results/reporting/en/. Accessed on 3 July 2015.
-
-
-
-
35
-
-
84925582285
-
European ombudsman questions European Medicines Agency over Abbvie redactions
-
Watson R. European ombudsman questions European Medicines Agency over Abbvie redactions. BMJ 2014;349:g6904.
-
(2014)
BMJ
, vol.349
, pp. g6904
-
-
Watson, R.1
|