Reporting Compliance of Stroke Trials: Cross-Sectional Analysis

Journal of Stroke and Cerebrovascular Diseases

Volumn 26, Issue 7, 2017, Pages 1472-1480

  Malhotra, Konark ^a   Rayi, Appaji ^a   Khunger, Monica ^b   Thompson, Stephanie ^a   Liebeskind, David S ^c  

^a WEST VIRGINIA UNIVERSITY   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

clinical trials; Clinicaltrials.gov; database; NIH; stroke

Indexed keywords

AGE; ARTICLE; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL (TOPIC); CROSS-SECTIONAL STUDY; FUNDING; HUMAN; PRIORITY JOURNAL; PROTOCOL COMPLIANCE; PUBLICATION; SYSTEMATIC REVIEW; UNITED STATES; ACCESS TO INFORMATION; COMPARATIVE STUDY; FACTUAL DATABASE; METHODOLOGY; PRACTICE GUIDELINE; REGISTER; STANDARDS; TIME FACTOR; TREATMENT OUTCOME; TRENDS;

ACCESS TO INFORMATION; CLINICAL TRIALS AS TOPIC; CROSS-SECTIONAL STUDIES; DATABASES, FACTUAL; GUIDELINE ADHERENCE; GUIDELINES AS TOPIC; HUMANS; REGISTRIES; RESEARCH DESIGN; STROKE; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 85017438630     PISSN: 10523057     EISSN: 15328511     Source Type: Journal    
DOI: 10.1016/j.jstrokecerebrovasdis.2017.03.010     Document Type: Article

References (39)

1. Malhotra, K., Liebeskind, D.S., Wake-up stroke: dawn of a new era. Brain Circ, 2, 2016, 72.
2. Lazzaro, M.A., Malhotra, K., Mohammad, Y.M., The role of antithrombotics in secondary stroke prevention. Semin Neurol 30 (2010), 492–500.
3. Malhotra, K., Liebeskind, D.S., Imaging in endovascular stroke trials. J Neuroimaging 25 (2015), 517–527.
4. Hudson, K.L., Collins, F.S., Sharing and reporting the results of clinical trials. JAMA 313 (2015), 355–356.
5. Chen, R., Desai, N.R., Ross, J.S., et al. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. BMJ, 352, 2016, i637.
6. Pearn, J., Publication: an ethical imperative. BMJ 310 (1995), 1313–1315.
7. Munro, A.J., Publishing the findings of clinical research. BMJ 307 (1993), 1340–1341.
8. Turner, E.H., Matthews, A.M., Linardatos, E., et al. Selective publication of antidepressant trials and its influence on apparent efficacy. N Engl J Med 358 (2008), 252–260.
9. U.S. Food and Drug Administration, Food and Drug Administration Amendments Act of 2007. Public Law, 110-85, 2007.
10. Anderson, M.L., Peterson, E.D., Compliance with results reporting at ClinicalTrials.gov. N Engl J Med 372 (2015), 2370–2371.
11. Saito, H., Gill, C.J., How frequently do the results from completed US clinical trials enter the public domain?—a statistical analysis of the ClinicalTrials.gov database. PLoS ONE, 9, 2014, e101826.
12. Zarin, D.A., Tse, T., Williams, R.J., et al. The ClinicalTrials.gov results database—update and key issues. N Engl J Med 364 (2011), 852–860.
13. Prayle, A.P., Hurley, M.N., Smyth, A.R., Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ, 344, 2012, d7373.
14. Kuehn, B.M., Few studies reporting results at US government clinical trials site. JAMA 307 (2012), 651–653.
15. ClinicalTrials.gov protocol data element definitions (DRAFT). 2016.
16. Zarin, D.A., Tse, T., Ide, N.C., Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 353 (2005), 2779–2787.
17. Zarin, D.A., Ide, N.C., Tse, T., et al. Issues in the registration of clinical trials. JAMA 297 (2007), 2112–2120.
18. Kesselheim, A.S., Mello, M.M., Confidentiality laws and secrecy in medical research: improving public access to data on drug safety. Health Aff (Millwood) 26 (2007), 483–491.
19. Drazen, J.M., Morrissey, S., Curfman, G.D., Open clinical trials. N Engl J Med 357 (2007), 1756–1757.
20. Shalowitz, D.I., Miller, F.G., Disclosing individual results of clinical research: implications of respect for participants. JAMA 294 (2005), 737–740.
21. De Angelis, C., Drazen, J.M., Frizelle, F.A., et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 351 (2004), 1250–1251.
22. Laine, C., Horton, R., DeAngelis, C.D., et al. Clinical trial registration—looking back and moving ahead. N Engl J Med 356 (2007), 2734–2736.
23. Liebeskind, D., Malhotra, K., Hinman, J., Imaging as the nidus of precision cerebrovascular health: a million brains initiative. JAMA Neurol 74 (2017), 257–258.
24. Jernberg, T., Attebring, M.F., Hambraeus, K., et al. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart 96 (2010), 1617–1621.
25. Kaplan, R.M., Irvin, V.L., Likelihood of null effects of large NHLBI clinical trials has increased over time. PLoS ONE, 10, 2015, e0132382.
26. Bernardez-Pereira, S., Lopes, R.D., Carrion, M.J., et al. Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials.gov registry. Am Heart J 168 (2014), 213–219 e1.
27. Alexander, K.P., Kong, D.F., Starr, A.Z., et al. Portfolio of clinical research in adult cardiovascular disease as reflected in ClinicalTrials.gov. J Am Heart Assoc, 2, 2013, e000009.
28. Bauchner, H., Golub, R.M., Fontanarosa, P.B., Data sharing: an ethical and scientific imperative. JAMA 315 (2016), 1237–1239.
29. Califf, R.M., Zarin, D.A., Kramer, J.M., et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 307 (2012), 1838–1847.
30. Massey, P.R., Wang, R., Prasad, V., et al. Assessing the eventual publication of clinical trial abstracts submitted to a large annual oncology meeting. Oncologist 21 (2016), 261–268.
31. Feczko, J., Clinical trials report card. N Engl J Med 354 (2006), 1426–1429 author reply 1426-9.
32. Global public policy issues: public disclosure of clinical research. 2014.
33. Clinical case study series: disclosure of clinical trials information. 2009.
34. Bowman, S.J., Macfarlane, G.J., Successful patient recruitment in investigator-led clinical trials. Rheumatology (Oxford) 46 (2007), 1207–1208.
35. Anderson, M.L., Chiswell, K., Peterson, E.D., et al. Compliance with results reporting at ClinicalTrials.gov. NEJM 372 (2015), 1031–1039.
36. National Institutes of Health, Final NIH policy on the use of a single institutional review board for multi-site research. 2016.
37. Law ignored, patients at risk. www.statnews.com, 2015.
38. Department of Health and Human Services, Final rule—clinical trials registration and results information submission. Fed Regist 81 (2016), 64981–65157.
39. National Institutes of Health, NIH policy on dissemination of NIH-funded clinical trial information. Fed Regist 81 (2016), 64922–64928.