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Sharing Clinical Research Data: Workshop Summary (2013)

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References Alsheikh-Ali, A. A., W. Qureshi, M. H. Al-Mallah, and J. P. Ioannidis. 2011. Public availability of published research data in high-impact journals. PLoS ONE 6(9):e24357. Alston, C., L. Paget, G. Halvorson, B. Novelli, J. Guest, P. McCabe, K. Hoffman, C. Koepke, M. Simon, S. Sutton, S. Okun, P. Wicks, T. Undem, V. Rohrbach, and I. Von Kohorn. 2012. Communicating with patients on health care evi- dence. Discussion Paper, Institute of Medicine, Washington, DC. http://www. iom.edu/evidence (accessed March 7, 2013). Antithrombotic Trialists’ Collaboration. 2002. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 324(7329):71-86. Erratum in: BMJ, 2002, 324(7330):141. Baigent, C., A. Keech, P. M. Kearney, L. Blackwell, G. Buck, C. Pollicino, A. Kirby, T. Sourjina, R. Peto, R. Collins, R. Simes, and Cholesterol Treatment Trialists’ (CTT) Collaborators. 2005. Efficacy and safety of cholesterol- lowering treatment: Prospective meta-analysis of data from 90,056 partici- pants in 14 randomised trials of statins. Lancet 366(9493):1267-1278. Erra- ta in: Lancet, 2008, 371(9630):2084; Lancet, 2005, 366(9494):1358. Califf, R. M., R. A. Harrington, L. K. Madre, E. D. Peterson, D. Roth, and K. A. Schulman. 2007. Curbing the cardiovascular disease epidemic: Aligning in- dustry, government, payers, and academics. Health Affairs (Millwood) 26(1):62-74. Chalmers, I. 2006. TGN1412 and the Lancet’s solicitation of reports of Phase I trials. Lancet 368(9554):2206-2207. Eichler, H.-G., E. Abadie, A. Breckenridge, H. Leufkens, and G. Rasi. 2012. Open clinical trial data for all? A view from regulators. PLoS Medicine 9(4):e1001202. EMA (European Medicines Agency). 2012. Access to clinical-trial data and transparency: Workshop report. http://www.ema.europa.edu/docs/en_GB/ 81

82 SHARING CLINICAL RESEARCH DATA document_library/Report/2012/12/WC500135841.pdf (accessed March 7, 2013). Gøtzsche, P. C. 2011. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 12:249. Hart, B., A. Lundh, and L. Bero. 2012. Effect of reporting bias on meta-analyses of drug trials: Reanalysis of meta-analyses. BMJ 344:d7202. HEW (Department of Health, Education and Welfare). 1979. The Belmont Re- port: Ethical principles and guidelines for the protection of human subjects of research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont. html (accessed March 7, 2013). Hrachovec, J. B., and M. Mora. 2001. Reporting of 6-month vs. 12-month data in a clinical trial of celecoxib. JAMA 286(19):2398; author reply 2399- 2400. Ioannidis, J. P., D. B. Allison, C. A. Ball, I. Coulibaly, X. Cui, A. C. Culhane, M. Falchi, C. Furlanello, L. Game, G. Jurman, J. Mangion, T. Mehta, M. Nitzberg, G. P. Page, E. Petretto, and V. van Noort. 2009. Repeatability of published microarray gene expression analyses. Nature Genetics 41(2):149- 155. Kesselheim, A. S., C. T. Robertson, J. A. Myers, S. L. Rose, V. Gillet, K. M. Ross, R. J. Glynn, S. Joffe, and J. Avorn. 2012. A randomized study of how physi- cians interpret research funding disclosures. New England Journal of Medicine 367(12):1119-1127. Kirwan, B. A., J. Lubsen, S. de Brouwer, F. J. van Dalen, S. J. Pocock, T. Clayton, N. Danchin, P. A. Poole-Wilson, and ACTION (A Coronary disease Trial Investigating Outcome with Nifedipine GITS) Investigators. 2008. Quality management of a large randomized double-blind multi-centre trial: The ACTION experience. Contemporary Clinical Trials 29(2):259-269. Krumholz, H. M., Y. Wang, J. Chen, E. E. Drye, J. A. Spertus, J. S. Ross, J. P. Curtis, B. K. Nallamothu, J. H. Lichtman, E. P. Havranek, F. A. Masoudi, M. J. Radford, L. F. Han, M. T. Rapp, B. M. Straube, and S. L. Normand. 2009. Reduction in acute myocardial infarction mortality in the United States: Risk-standardized mortality rates from 1995-2006. JAMA 302(7):767-773. Laine, C., S. N. Goodman, M. E. Griswold, and H. C. Sox. 2007a. Reproducible research: Moving toward research the public can really trust. Annals of Internal Medicine 146(6):450-453. Laine, C., R. Horton, C. D. DeAngelis, J. M. Drazen, F. A. Frizelle, F. Godlee, C. Haug, P. C. Hébert, S. Kotzin, A. Marusic, P. Sahni, T. V. Schroeder, H. C. Sox, M. B. Van der Weyden, and F. W. Verheugt. 2007b. Clinical trial registration—looking back and moving ahead. New England Journal of Medicine 356(26):2734-2736. McCullough, P. A., and N. E. Lepor. 2005. The deadly triangle of anemia, renal insufficiency, and cardiovascular disease: Implications for prognosis and treatment. Reviews in Cardiovascular Medicine 6(1):1-10.

REFERENCES 83 Michele, T. M., S. Pinheiro, and S. Iyasu. 2010. The safety of tiotropium—the FDA’s conclusions. New England Journal of Medicine 363(12):1097-1099. NRC (National Research Council). 2010. A foundation for evidence-driven practice: A rapid learning system for cancer care: Workshop summary. Washington, DC: The National Academies Press. Peng, R. D., F. Dominici, and S. L. Zeger. 2006. Reproducible epidemiologic research. American Journal of Epidemiology 163(9):783-789. Piwowar, H. A., R. S. Day, D. and B. Fridsma. 2007. Sharing Detailed Research Data Is Associated with Increased Citation Rate. PLoS ONE 2(3):e308. doi:10.1371/journal.pone.0000308 Platt, R. 2012. Distributed networks can facilitate working remotely with re- search datasets derived from routinely collected electronic health infor- mation, often eliminating the need to transfer sensitive data. Presentation at IOM Workshop on Sharing Clinical Research Data, October 4-5, Washing- ton, DC. Riley, R. D., P. C. Lambert, and G. Abo-Zaid. 2010. Meta-analysis of individual participant data: Rationale, conduct, and reporting. BMJ 340:c221. Rodwin, M. A., and J. D. Abramson. 2012. Clinical trial data as a public good. JAMA 308(9):871-872. Savage C. J., and A. J. Vickers. 2009. Empirical Study of Data Sharing by Au- thors Publishing in PLoS Journals. PLoS ONE 4(9):e7078. doi:10.1371/ journal.pone.0007078. Silverstein, F. E., G. Faich, J. L. Goldstein, L. S. Simon, T. Pincus, A. Whelton, R. Makuch, G. Eisen, N. M. Agrawal, W. F. Stenson, A. M. Burr, W. W. Zhao, J. D. Kent, J. B. Lefkowith, K. M. Verburg, and G. Geis. 2000. Gas- trointestinal 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. Singh, S., Y. K. Loke, and C. D. Furberg. 2008. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstruc- tive pulmonary disease: A systematic review and meta-analysis. JAMA 300(12):1439-1450. Erratum in: JAMA, 2009, 301(12):1227-1230. Vickers, A. J. 2006. Whose data set is it anyway? Sharing raw data from ran- domized trials. Trials 7:15. Wagner, J. A., E. C. Wright, M. M. Ennis, M. Prince, J. Kochan, D. J. Nunez, B. Schneider, M. D. Wang, Y. Chen, S. Ghosh, B. J. Musser, and M. T. Vassileva. 2009. Utility of adiponectin as a biomarker predictive of glyce- mic efficacy is demonstrated by collaborative pooling of data from clinical trials conducted by multiple sponsors. Clinical Pharmacology & Therapeu- tics 86(6):619-625. Walport, M., and P. Brest. 2011. Sharing research data to improve public health. Lancet 377(9765):537-539.

84 SHARING CLINICAL RESEARCH DATA Williams, B., V. Entwistle, G. Haddow, and M. Wells. 2008. Promoting re- search participation: Why not advertise altruism? Social Science & Medi- cine 66(7):1451-1456. Zarin, D. A. 2012. Information loss as clinical trials data progresses from raw uncoded data to summary data. Presentation at IOM workshop on Sharing Clinical Research Data, October 4-5, Washington, DC. Zarin, D. A., T. Tse, R. J. Williams, R. M. Califf, and N. C. Ide. 2011. The ClinicalTrials.gov results database—update and key issues. New England Journal of Medicine 364(9):852-860.

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Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets.

This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

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