Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results
article has not abstract
Vyšlo v časopise:
Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results. PLoS Med 5(11): e230. doi:10.1371/journal.pmed.0050230
Kategorie:
Perspective
prolekare.web.journal.doi_sk:
https://doi.org/10.1371/journal.pmed.0050230
Souhrn
article has not abstract
Zdroje
1. McHenryLBJureidiniJN
2008
Industry-sponsored ghostwriting in clinical trial reporting: A case study.
Account Res
15
152
167
2. JureidiniJNMcHenryLBMansfieldPR
2008
Clinical trials and drug promotion: Selective reporting of study 329.
Int J Risk Safety Med
20
73
81
3. PsatyBMKronmalRA
2008
Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: A case study based on documents from rofecoxib litigation.
JAMA
299
1813
1817
4. CurfmanGDMorrisseySDrazenJM
2006
Expression of concern reaffirmed.
N Engl J Med
354
1193
5. WhittingtonCJKendallTFonagyPCottrellDCotgroveA
2004
Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data.
Lancet
363
1341
1345
6. DwanKAltmanDGArnaizJABloomJChanA-W
2008
Systematic review of the empirical evidence of study publication bias and outcome reporting bias.
PLoS ONE
3
e3081
doi:10.1371/journal.pone.0003081
7. SongFEastwoodAJGilbodySDuleyLSuttonAJ
2000
Publication and related biases.
Health Technol Assess
4
1
115
8. DickersinK
1997
How important is publication bias? A synthesis of available data.
AIDS Educ Prev
9
15
21
9. RisingKBacchettiPBeroL
2008
Reporting bias in drug trials submitted to the Food and Drug Administration: A review of publication and presentation.
PLoS Med
5
e217
doi:10.1371/journal.pmed.0050217
10. TurnerEHMatthewsAMLinardatosETellRARosenthalR
2008
Selective publication of antidepressant trials and its influence on apparent efficacy.
N Engl J Med
358
252
260
11. MelanderHAhlqvist-RastadJMeijerGBeermannB
2003
Evidence b(i)ased medicine—Selective reporting from studies sponsored by pharmaceutical industry: Review of studies in new drug applications.
BMJ
326
1171
1173
12. HemminkiE
1980
Study of information submitted by drug companies to licensing authorities.
BMJ
280
833
836
13. ChanA-WHróbjartssonAJørgensenKJGøtzschePCAltmanDG
2008
Discrepancies in sample size calculations and data analyses reported in randomized trials: Comparison of publications with protocols.
BMJ
In press
14. ChanA-WHróbjartssonAHaahrMTGøtzschePCAltmanDG
2004
Empirical evidence for selective reporting of outcomes in randomized trials: Comparison of protocols to published articles.
JAMA
291
2457
2465
15. HahnSWilliamsonPRHuttonJL
2002
Investigation of within-study selective reporting in clinical research: Follow-up of applications submitted to a local research ethics committee.
J Eval Clin Pract
8
353
359
16. PildalJChanA-WHróbjartssonAForfangEAltmanDG
2005
Does unclear allocation concealment in trial publications reflect poor methods or poor reporting of adequate methods? Cohort study of trial protocols and corresponding published reports.
BMJ
330
1049
1052
17. ChanA-WKrleža-JericKSchmidIAltmanDG
2004
Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.
CMAJ
171
735
740
18. ScharfOColevasAD
2006
Adverse event reporting in publications compared with sponsor database for cancer clinical trials.
J Clin Oncol
24
3933
3938
19. SoaresHPDanielsSKumarAClarkeMScottC
2004
Bad reporting does not mean bad methods for randomised trials: Observational study of randomised controlled trials performed by the Radiation Therapy Oncology Group.
BMJ
328
22
24
20. Al-MarzoukiSRobertsIEvansSMarshallT
2008
Selective reporting in clinical trials: Analysis of trial protocols accepted by The Lancet.
Lancet
372
201
21. LeeKBacchettiPSimI
2008
Publication of clinical trials supporting successful new drug applications: A literature analysis.
PLoS Med
5
e191
doi:10.1371/journal.pmed.0050191
22. MorganSGBassettKLWrightJMEvansRGBarerML
2005
“Breakthrough” drugs and growth in expenditure on prescription drugs in Canada.
BMJ
331
815
816
23. TurnerEH
2004
A taxpayer-funded clinical trials registry and results database.
PLoS Med
1
e60
doi:10.1371/journal.pmed.0010060
24. ChanA-WAltmanDG
2005
Epidemiology and reporting of randomised trials published in PubMed journals.
Lancet
365
1159
1162
25. ChanA-WUpshurRSinghJAGhersiDChapuisF
2006
Research protocols: Waiving confidentiality for the greater good.
BMJ
332
1086
1089
26. LuriePZieveA
2008
Sometimes the silence can be like the thunder: Access to pharmaceutical data at the FDA.
Law Contemporary Problems
69
85
97
27. ChanA-WTetzlaffJAltmanDGGøtzschePCHróbjartssonA
2008
The SPIRIT initiative: Defining Standard Protocol Items for Randomized Trials [conference abstract].
German J Evid Quality Health Care (suppl)
102
S27
28. World Health Organization
2008
International Clinical Trials Registry Platform.
Available: http://www.who.int/ictrp/en/. Accessed 20 October 2008
29. The PLoS Medicine Editors
2008
Next stop, don't block the doors: Opening up access to clinical trials results.
PLoS Med
5
e160
doi:10.1371/journal.pmed.0050160
30. United States Congress
2007
Food and Drug Administration Amendments Act of 2007, Title VIII, Section 801. Expanded clinical trial registry data bank.
Available: http://www.govtrack.us/congress/billtext.xpd?bill=h110-3580. Accessed 20 October 2008
31. SimIChanA-WGulmezogluAMEvansTPangT
2006
Clinical trial registration: Transparency is the watchword.
Lancet
367
1631
1633
32. DeAngelisCDDrazenJMFrizelleFAHaugCHoeyJ
2005
Is this clinical trial fully registered?: A statement from the International Committee of Medical Journal Editors.
JAMA
293
2927
2929
33. Krleža-JericKChanA-WDickersinKSimIGrimshawJ
2005
Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1).
BMJ
330
956
958
34. PLoS Medicine
2008
Guidelines for authors.
Available: http://journals.plos.org/plosmedicine/guidelines.php#supporting. Accessed 20 October 2008
35. McNameeDJamesAKleinertS
2008
Protocol review at The Lancet.
Lancet
372
189
190
36. JonesGAbbasiK
2004
Trial protocols at the BMJ.
BMJ
329
1360
37. LassereMJohnsonK
2002
The power of the protocol.
Lancet
360
1620
1622
38. HawkeyCJ
2001
Journals should see original protocols for clinical trials.
BMJ
323
1309
39. MitkaM
2008
Controversies surround heart drug study: Questions about Vytorin and trial sponsors' conduct.
JAMA
299
885
887
Štítky
Interné lekárstvoČlánok vyšiel v časopise
PLOS Medicine
2008 Číslo 11
- MUDr. Dana Vondráčková: Hepatopatie sú pri liečbe metamizolom väčším strašiakom ako agranulocytóza
- Metamizol v liečbe pooperačnej bolesti u detí do 6 rokov veku
- Parazitičtí červi v terapii Crohnovy choroby a dalších zánětlivých autoimunitních onemocnění
- Vztah mezi statiny a rizikem vzniku nádorových onemocnění − metaanalýza
- Statiny indukovaná myopatie: Jak na diferenciální diagnostiku?
Najčítanejšie v tomto čísle
- Multiple Masses on the Tongue of a Patient with Generalized Mucocutaneous Lesions
- Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions
- Estimating the Global Burden of Snakebite Can Help To Improve Management
- Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation