References

AllTrials. 2013. The AllTrials campaign calls for all past and present clinical trials to be registered and their results reported. http://www.alltrials.net/alltrials (accessed October 1, 2013).

ADNI (Alzheimers Disease Neuroimaging Initiative). 2013. ADNI overview. http://www.adni-info.org/Scientists/ADNIOverview.aspx (accessed October 12, 2013).

Article 29 Data Protection Working Party. 2013. Opinion 03/2013 on purpose limitation, 00569/13/EN WP 203, at 29 (2 April 2013). http://ec.europa.eu/justice/data-protection/article-29/documentation/opinion-recommendation/files/2013/wp203_en.pdf (accessed January 3, 2014).

Beauchamp, T. L., and J. F. Childress. 2009. Principles of biomedical ethics. 6th ed. New York: Oxford University Press.

Benitez, K., and B. Malin. 2010. Evaluating re-identification risks with respect to the HIPAA privacy rule. Journal of the American Medical Informatics Association 17(2):169-177.

Bioethics Commission (Presidential Commission for the Study of Bioethical Issues). 2011. “Ethically Impossible” STD Research in Guatemala from 1946 to 1948. http://bioethics.gov/node/654 (accessed November 6, 2013).

Boulton, G., M. Rawlins, P. Vallance, and M. Walport. 2011. Science as a public enterprise: The case for open data. Lancet 377(9778):1633-1635.

Califf, R. 2013. Clinical trial data and challenges to data sharing: Current and future. Presentation at Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting 1, Open Sessions: Institute of Medicine Workshop, October 23, Washington, DC.

Childress, J. F., E. M. Meslin, and H. T. Shapiro. 2005. Belmont revisited: Ethical principles for research with human subjects. Washington, DC: Georgetown University Press.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 37
References AllTrials. 2013. The AllTrials campaign calls for all past and present clinical trials to be registered and their results reported. http://www.alltrials.net/all- trials (accessed October 1, 2013). ADNI (Alzheimers Disease Neuroimaging Initiative). 2013. ADNI overview. http://www.adni-info.org/Scientists/ADNIOverview.aspx (accessed October 12, 2013). Article 29 Data Protection Working Party. 2013. Opinion 03/2013 on purpose limitation, 00569/13/EN WP 203, at 29 (2 April 2013). http://ec.europa.eu/ justice/data-protection/article-29/documentation/opinion-recommendation/ files/2013/wp203_en.pdf (accessed January 3, 2014). Beauchamp, T. L., and J. F. Childress. 2009. Principles of biomedical ethics. 6th ed. New York: Oxford University Press. Benitez, K., and B. Malin. 2010. Evaluating re-identification risks with respect to the HIPAA privacy rule. Journal of the American Medical Informatics Association 17(2):169-177. Bioethics Commission (Presidential Commission for the Study of Bioethical Issues). 2011. “Ethically Impossible” STD Research in Guatemala from 1946 to 1948. http://bioethics.gov/node/654 (accessed November 6, 2013). Boulton, G., M. Rawlins, P. Vallance, and M. Walport. 2011. Science as a public enterprise: The case for open data. Lancet 377(9778):1633-1635. Califf, R. 2013. Clinical trial data and challenges to data sharing: Current and future. Presentation at Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting 1, Open Sessions: Institute of Medicine Workshop, October 23, Washington, DC. Childress, J. F., E. M. Meslin, and H. T. Shapiro. 2005. Belmont revisited: Ethical principles for research with human subjects. Washington, DC: Georgetown University Press. 37

OCR for page 37
38 DISCUSSION FRAMEWORK FOR CLINICAL TRIAL DATA SHARING CIOMS (Council for International Organizations of Medical Sciences). 2002. International ethical guidelines for biomedical research involving human subjects. http://www.cioms.ch/index.php/publications/printable-publications? task=view&id=48&catid=57 (accessed November 5, 2013). ClinicalTrials.gov. 2012. Glossary of commons site terms. http://clinical trials.gov/ct2/about-studies/glossary#I (accessed November 5, 2013). Cochrane Collaboration. 2002. The Cochrane Collaboration open learning material: Publication bias. http://www.cochrane-net.org/openlearning/html/ mod15-2.htm (accessed November 20, 2013). CTSA (Clinical and Translational Science Awards) Community Engagement Key Function Committee Task Force. 2011. Principles of community engagement: Second edition. Washington, DC: NIH. Dickersin, K. 2013. Principles of responsible data sharing. Paper read at Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting 1, Open Sessions: Institute of Medicine Workshop, October 23, Washington, DC. Doshi, P., T. Jefferson, and C. Del Mar. 2012. The imperative to share clinical study reports: Recommendations from the Tamiflu experience. PLoS Medicine 9(4):e1001201. Doshi, P., K. Dickersin, D. Healy, S. S. Vedula, and T. Jefferson. 2013. Restoring invisible and abandoned trials: A call for people to publish the findings. BMJ (Online) 346(7913). Drazen, J. M. 2002. Who owns the data in clinical trial? Science and Engineering Ethics 8(3):407-411. Eichler, H. G., F. Pétavy, F. Pignatti, and G. Rasi G. 2013. Access to patient- level trial data: A boon to drug developers. New England Journal of Medicine 369(17):1577-1579. El Emam, K., F. Dankar, A. Neisa, and E. Jonker. 2013. Evaluating the risk of patient re-identification from adverse drug event reports. BMC Medical Informatics and Decision Making 13(1):114. Emanuel, E. J., D. Wendler, and C. Grady. 2008. An ethical framework for biomedical research. In Oxford textbook of research ethics, edited by E. J. Emanuel, C. Grady, R. A. Crouch, R. K. Lie, F. G. Miller and D. Wendler. New York: Oxford University Press. Pp. 123-135. EMA (European Medicines Agency). 2013. Publication and access to clinical- trial data. http://www.ema.europa.eu/docs/en_GB/document_library/Other/ 2013/06/WC500144730.pdf (accessed December 1, 2013). European Commission. 2013. Protection of personal data. http://ec.europa. eu/justice/data-protection (accessed November 22, 2013). Evans, B. J. 2011. Much ado about data ownership. Harvard Journal of Law and Technology 25. http://ssrn.com/abstract=1857986 (accessed December 6, 2013). Faden, R., N. Kass, D. Whicher, W. Stewart, and S. Tunis. 2013. Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data. Medical Care 51(8 Suppl 3):S53-S57.

OCR for page 37
REFERENCES 39 FDA (U.S. Food and Drug Administration). 1996. Guideline for industry: Structure and content of clinical study reports. http://www.fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm073113.pdf (accessed November 7, 2013). FDA. 1999. Guidance for industry: Submission of abbreviated reports and synopses in support of marketing applications. http://www.fda.gov/ downloads/Drugs/Guidances/ucm072053.pdf (accessed November 7, 2013). FDA. 2013. Availability of masked and deidentified non-summary safety and efficacy data; request for comments. 78 Federal Register 33421 (June 4), p. 60290. Getz, K., Z. Hallinan, D. Simmons, M. J. Brickman, Z. Jumadilova, L. Pauer, M. Wilenzick, and B. Morrison. 2012. Meeting the obligation to communicate clinical trial results to study volunteers. Expert Reviews in Clinical Pharmacology 5(2):149-156. Gibson, L. 2004. GlaxoSmithKline to publish clinical trials after U.S. lawsuit. BMJ 328(7455):1513. Godlee, F., and T. Groves. 2012. The new BMJ policy on sharing data from drug and device trials. BMJ (Online) 345(7884):1-3. Goldacre, B. 2012. Bad pharma: How medicine is broken and how we can fix it. Revised and updated edition. London: Faber & Faber. Gordon, D., W. Taddei-Peters, A. Mascette, M. Antman, P. G. Kaufmann, and M. S. Lauer. 2013. Publication of trials funded by the National Heart, Lung, and Blood Institute. New England Journal of Medicine 369(20):1926-1934. Gross, C. P., H. M. Krumholz, G. Van Wye, E. J. Emanuel, D. Wendler. 2006. Does random treatment assignment cause harm to research participants? PLoS Medicine 3(6):e188. Gymrek, M., A. L. McGuire, D. Golan, E. Halperin, and Y. Erlich. 2013. Identifying personal genomes by surname inference. Science 339(6117):321-324. Harvard University MRCT (Multi-Regional Clinical Trials Center Data Sharing Workgroup). 2013. Paper presented at Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions Conference, May 17, Cambridge, MA. ICH (International Conference on Harmonisation). 1995. Structure and content of clincial study reports (E3). http://www.ich.org/products/guidelines/ efficacy/efficacy-single/article/structure-and-content-of-clinical-study- reports.html (accessed November 7, 2013). ICH. 1996. Guideline for good clinical practice E6(R1). http://www.ich.org/ products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html (accessed November 5, 2013). Immport (Immunology Database and Analysis Portal). 2013. Immport: Bioinformatics for the future of immunology. https://immport.niaid.nih.gov/ immportWeb/home/home.do?loginType=full (accessed November 15, 2013). Immune Tolerance Network. 2013. Trial share: Clinical trials research portal. https://www.itntrialshare.org (accessed September 25, 2013).

OCR for page 37
40 DISCUSSION FRAMEWORK FOR CLINICAL TRIAL DATA SHARING IOM (Institute of Medicine). 2002. Unequal treatment: Confronting racial and ethnic disparities in health care. Washington, DC: The National Academies Press. IOM. 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press. Jiang, X. P., A. D. P. Sarwate, and L. P. M. D. Ohno-Machado. 2013. Privacy technology to support data sharing for comparative effectiveness research: A systematic review. Medical Care 51(8):S58-S65. Jones, J. H. 2008. Tuskegee syphilis experiment. In The Oxford textbook of clinical research ethics, edited by E. J. Emanuel, C. Grady, R. A. Crouch, R. K. Lie, F. G. Miller and D. Wendler. New York: Oxford University Press. Pp. 86-96. Kaiser, L., C. Wat, T. Mills, P. Mahoney, P. Ward, and F. Hayden. 2003. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Archives of Internal Medicine 163(14): 1667-1672. Krumholz, H. M., and J. S. Ross. 2011. A model for dissemination and independent analysis of industry data. JAMA 306(14):1593-1594. Kuntz, R. E. 2013. The changing structure of industry-sponsored clinical research: Pioneering data sharing and transparency. Annals of Internal Medicine 158(12):914-915. Laine, C., S. N. Goodman, M. E. Griswold, and H. C. Sox. 2007. Reproducible research: Moving toward research the public can really trust. Annals of Internal Medicine 146(6):450-453. Laine, C., E. Guallar, C. Mulrow, D. B. Taichman, J. E. Cornell, D. Cotton, M. E. Griswold, A. R. Localio, A. R. Meibohm, C. B. Stack, S. V. Williams, and S. N. Goodman. 2013. Closing in on the truth about recombinant human bone morphogenetic protein-2: Evidence synthesis, data sharing, peer review, and reproducible research. Annals of Internal Medicine 158(12):916-918. Lidz, C. W., P. S. Appelbaum, T. Grisso, and M. Renaud. 2004. Therapeutic misconception and the appreciation of risks in clinical trials. Social Science & Medicine 58(9):1689-1697. Loder, E. 2013. Sharing data from clinical trials: Where we are and what lies ahead. BMJ 347:f4794. McGauran, N., B. Wieseler, J. Kreis, Y.-B. Schuler, H. Kolsch, and T. Kaiser. 2010. Reporting bias in medical research—a narrative review. Trials 11(1):37. McGraw, D., K. Rosati, and B. Evans. 2012. A policy framework for public health uses of electronic health data. Pharmacoepidemiology and Drug Safety 21:18-22. Mello, M. 2013. Preparing for responsible sharing of clinical trial data. Presentation at Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting 1, Open Sessions: Institute of Medicine Workshop, October 23, Washington, DC.

OCR for page 37
REFERENCES 41 Mello, M. M., J. K. Francer, M. Wilenzick, P. Teden, B. E. Bierer, and M. Barnes. 2013. Preparing for responsible sharing of clinical trial data. New England Journal of Medicine 369(17):1651-1658. National Commission (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). 1979. The Belmont report: Ethical principles and guidelines for the protection of human subjects of biomedical and behavioral research. http://www.hhs.gov/ohrp/ humansubjects/guidance/belmont.html (accessed December 1, 2013). NIH (National Institutes of Health). 2003. Final NIH statement on sharing research data. http://grants.nih.gov/grants/policy/data_sharing (accessed January 3, 2014). NHLBI (National Heart, Lung, and Blood Institute). 2007. Biologic specimen and data repository information coordinating center. https://biolincc. nhlbi.nih.gov/home (accessed November 16, 2013). Nisen, P., and F. Rockhold. 2013. Access to patient-level data from GlaxoSmithKline clinical trials. New England Journal of Medicine 369(5):475-478. Nissen, S. E., and K. Wolski. 2007. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. New England Journal of Medicine 356(24):2457-2471. PhRMA (Pharmaceutical Research and Manufacturers of America) and EFPIA (European Federation of Pharmaceutical Industries and Associations). 2013. Principles for responsible clinical trial data sharing: Our commitment to patients and researchers. http://phrma.org/sites/default/files/pdf/PhRMA PrinciplesForResponsibleClinicalTrialDataSharing.pdf (accessed September 20, 2013). Rathi, V., K. Dzara, C. P. Gross, I. Hrynaszkiewicz, S. Joffe, H. M. Krumholz, K. M. Strait, and J.S. Ross. 2012. Sharing of clinical trial data among trialists: a cross sectional survey. BMJ 345:e7570. Rawlins, M. 2012. Saints or sinners. Lancet 380(9852):1462-1463. Ross, J. S., R. Lehman, and C. P. Gross. 2012. The importance of clinical trial data sharing: Toward more open science. Circulation: Cardiovascular Quality and Outcomes 5(2):238-240. Royal Society. 2012. Science as an open enterprise. London: Royal Society. Silverstein, F. E., G. Faich, J. L. Goldstein, and et al. 2000. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: The class study: A randomized controlled trial. JAMA 284(10):1247-1255. Simmonds, M. C., J. V. E. Brown, M. K. Heirs, J. P. T. Higgins, R. J. Mannion, M. A. Rodgers, and L. A. Stewart. 2013. Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusiona meta- analysis of individual-participant data. Annals of Internal Medicine 158(12):877-889.

OCR for page 37
42 DISCUSSION FRAMEWORK FOR CLINICAL TRIAL DATA SHARING Spertus, J. A. 2012. The double-edged sword of open access to research data. Circulation: Cardiovascular Quality and Outcomes 5(2):143-144. Stiles, P. G., and J. Petrila. 2011. Research and confidentiality: Legal issues and risk management strategies. Psychology, Public Policy, and Law 17(3):333- 356. Teden, P. 2013. Types of clinical trial data to be shared. Presentation at Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting 1, Open Sessions: Institute of Medicine Workshop, October 23, Washington, DC. Terry, S. F., and P. F. Terry. 2011. Power to the people: Participant ownership of clinical trial data. Science Translational Medicine 3(69):69cm63. Weijer, C., and E. J. Emanuel. 2000. Protecting communities in biomedical research. Science 289(5482):1142-1144. Weil, D., M. Graham, and A. Fung. 2013. Science and regulation. Targeting transparency. Science 340(6139):1410-1411. Wellcome Trust. 2011. Sharing research data to improve public health: Full joint statement by funders of health research. http://www.wellcome.ac.uk/ About-us/Policy/Spotlight-issues/Data-sharing/Public-health-and-epidemiology/ WTDV030690.htm (accessed October 15, 2013). Wendler, D., R. Kington, J. Madans, G. Van Wye, H. Christ-Schmidt, L. A. Pratt, O. W. Brawley, C. P. Gross, and E. Emanuel. 2006. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 3(2):e19. Wertheimer, A. 2008. Exploitation in clinical research. In The Oxford textbook of clinical research ethics, edited by E. J. Emanuel, C. Grady, R. A. Crouch, R. K. Lie, F. G. Miller, and D. Wendler. New York: Oxford University Press. Pp. 201-210. White House. 2011. The Obama administration’s commitment to open government: A status report. http://www.whitehouse.gov/sites/default/ files/opengov_report.pdf (accessed October 6, 2013). WMA (World Medical Association). 2013. World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/ index.html (accessed November 5, 2013). YODA (Yale Open Data Access). 2013. Yale University Open Data Access (YODA) project policy for the public availability of rhBMP-2 clinical trial data. New Haven, CT: Yale University Center for Outcomes Research and Evaluation.