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 evidence. 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 participants in 14 randomised trials of statins. Lancet 366(9493):1267-1278. Errata 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 industry, 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/document_library/Report/2012/12/WC500135841.pdf



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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

OCR for page 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.

OCR for page 81
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.

OCR for page 81
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.