Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov

References

• Chan, A. W., Tetzlaff, J. M., Gøtzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A., Dickersin, K., Hrobjartsson, A., Schulz, K. F., Parulekar, W. R., Krleza-Jeric, K., Laupacis, A., and Moher, D. (2013). SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 346: e7586.
   PubMed Web of Science ®Google Scholar
• Congressional Research Service. (2008). FDA Amendments Act of 2007. PL 110–85. Domestic Social Policy Division. Last modified April 28, 2008. Available at http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf. Last accessed November 5, 2015.
   Google Scholar
• Goldacre, B. (2012). Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. New York: Faber and Faber, Inc.
   Google Scholar
• Gøtzsche, P. C., Hrobjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., and Chan, A. W. (2006). Constraints on publication rights in industry-initiated clinical trials. JAMA, 295(14): 1645–1646.
   PubMed Web of Science ®Google Scholar
• Graf, C., Battisti, W. P., Bridges, D., Bruce-Winkler, V., Conaty, J. M., Ellison, J. M., Field, E. A., Gurr, J. A., Marx, M. E., Patel, M., Sanes-Miller, C., and Yarker, Y. E. (2009). Research methods and reporting. Good publication practice for communicating company sponsored medical research: The GPP2 guidelines. BMJ, 339: b4330.
   PubMed Web of Science ®Google Scholar
• Hailey, D. (2000). Scientific harassment by pharmaceutical companies: time to stop. CMAJ, 162(2): 212–213.
   PubMed Web of Science ®Google Scholar
• Harvard School of Public Health. (2000). UCSF-Harvard team publishes major HIV therapy study over objections of sponsor; compound shows no effect on slowing disease progression. Last modified October 31, 2000. Available at http://archive.sph.harvard.edu/press-releases/archives/2000-releases/press10312000b.html. Last accessed November 5, 2015.
   Google Scholar
• International Committee of Medical Journal Editors. (ICMJE). (2013). Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals. Roles and responsibilities of authors, contributors, reviewers, editors, publishers, and owners: defining the role of authors and contributors. Last modified December 30, 2013. Available at http://www.icmje.org/icmje-recommendations.pdf. Last accessed November 5, 2015.
   Google Scholar
• International Federation of Pharmaceutical Manufacturers and Associations. (IFPMA). (2009). Joint position on the disclosure of clinical trial information via clinical trial registries and databases. Last modified November 10, 2009. Available at http://www.ifpma.org/fileadmin/content/Ethics/Clinical_Trials/Nov2009_Joint_Position_CT_Data_Disclosure_registries_and_databases.pdf. Last accessed November 5, 2015.
   Google Scholar
• Lundh, A., Krogsboll, L. T., and Gøtzsche, P. C. (2012). Sponsors’ participation in conduct and reporting of industry trials: a descriptive study. Trials, 13: 146.
   PubMed Web of Science ®Google Scholar
• Mello, M. M., Clarridge, B. R., and Studdert, D. M. (2005). Academic medical centers’ standards for clinical-trial agreements with industry. N. Engl. J. Med., 352(21): 2202–2210.
   PubMed Web of Science ®Google Scholar
• Mello, M. M., Clarridge, B. R., and Studdert, D. M. (2005). Researchers’ views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors. Account Res., 12(3): 163–191.
   PubMedGoogle Scholar
• Porter, P. D., Longmire, B., and Abrol, A. (2009). Negotiating clinical trial agreements: Bridging the gap between research institutions and companies. J. Health Life Sci. Law, 2(3): 121–142.
   PubMedGoogle Scholar
• Schulman, K. A., Seils, D. M., Timbie, J. W., Sugarman, J., Dame, L. A., Weinfurt, K. P., Mark, D. B., and Califf, R. M. (2002). A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N. Engl. J. Med., 347(17): 1335–1341.
   PubMed Web of Science ®Google Scholar
• Steinbrook, R. (2005). Gag clauses in clinical-trial agreements. N. Engl. J. Med., 352(21): 2160–2162.
   PubMed Web of Science ®Google Scholar
• Viens, A. M. and Savulescu, J. (2004). Introduction to the Olivieri symposium. J. Med. Ethics, 30(1): 1–7.
   PubMed Web of Science ®Google Scholar
• Wager, E., Woolley, K., Adshead, V., Cairns, A., Fullam, J., Gonzalez, J., Grant, T., and Tortell, S. (2014). Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: The Global Publication Survey. BMJ Open, 4(4): e004780.
   PubMed Web of Science ®Google Scholar
• Woolley, K. L., Gertel, A., Hamilton, C., Jacobs, A., and Snyder, G. (2012). Poor compliance with reporting research results: We know it’s a problem … how do we fix it? Curr. Med. Res. Opin., 28(11): 1857–1860.
   PubMed Web of Science ®Google Scholar