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Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
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Appendix A

References

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Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×

Duma, N., J. Vera Aguilera, J. Paludo, C. L. Haddox, M. Gonzalez Velez, Y. Wang, K. Leventakos, J. M. Hubbard, A. S. Mansfield, R. S. Go, and A. A. Adjei. 2018. Representation of minorities and women in oncology clinical trials: Review of the past 14 years. Journal of Oncology Practice 14(1):e1–e10.

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Gay, H. C., A. S. Baldridge, and M. D. Huffman. 2017. Feasibility, process, and outcomes of cardiovascular clinical trial data sharing: A reproduction analysis of the SMART-AF Trial. JAMA Cardiology 2(12):1375–1379.

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IOM. 2013. Sharing clinical research data: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2015. Sharing clinical trial data: Maximizing benefits, minimizing risk. Washington, DC: The National Academies Press.

Kochhar, S., B. Knoppers, C. Gamble, A. Chant, J. Koplan, and G. S. Humphreys. 2019. Clinical trial data sharing: Here’s the challenge. BMJ Open 9(8):e032334.

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Kush, R., and M. Goldman. 2014. Fostering responsible data sharing through standards. New England Journal of Medicine 370(23):2163–2165.

Land, S. R., B. A. Toll, C. M. Moinpour, S. A. Mitchell, J. S. Ostroff, D. K. Hatsukami, S. A. Duffy, E. R. Gritz, N. A. Rigotti, T. H. Brandon, S. A. Prindiville, L. P. Sarna, R. A. Schnoll, R. S. Herbst, P. M. Cinciripini, S. J. Leischow, C. M. Dresler, M. C. Fiore, and G. W. Warren. 2016. Research priorities, measures, and recommendations for assessment of tobacco use in clinical cancer research. Clinical Cancer Research 22(8):1907–1913.

Lo, B., and D. J. DeMets. 2016. Incentives for clinical trialists to share data. New England Journal of Medicine 375(12):1112–1115.

Mbuagbaw, L., L. Guglielmetti, C. Hewison, N. Bakare, M. Bastard, E. Caumes, M. Fréchet-Jachym, J. Robert, N. Veziris, N. Khachatryan, T. Kotrikadze, A. Hayrapetyan, Z. Avaliani, H. J. Schünemann, and C. Lienhardt. 2019. Outcomes of bedaquiline treatment in patients with multidrug-resistant tuberculosis. Emerging Infectious Diseases 25(5):936–943.

Mello, M. M., V. Lieou, and S. N. Goodman. 2018. Clinical trial participants’ views of the risks and benefits of data sharing. New England Journal of Medicine 378(23):2202–2211.

Ohmann, C., R. Banzi, S. Canham, S. Battaglia, M. Matei, C. Ariyo, L. Becnel, B. Bierer, S. Bowers, L. Clivio, M. Dias, C. Druml, H. Faure, M. Fenner, J. Galvez, D. Ghersi, C. Gluud, T. Groves, P. Houston, G. Karam, D. Kalra, R. L. Knowles, K. Krleža-Jerić, C. Kubiak, W. Kuchinke, R. Kush, A. Lukkarinen, P. S. Marques, A. Newbigging, J. O’Callaghan, P. Ravaud, I. Schlünder, D. Shanahan, H. Sitter, D. Spalding, C. Tudur Smith, P. van Reusel, E. van Veen, G. R. Visser, J. Wilson, and J. Demotes-Mainard. 2017. Sharing and reuse of individual participant data from clinical trials: Principles and recommendations. BMJ Open 7(12):e018647.

Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×

Peters, E. N., E. Torres, B. A. Toll, K. M. Cummings, E. R. Gritz, A. Hyland, R. S. Herbst, J. R. Marshall, and W. G. Warren. 2012. Tobacco assessment in actively accruing National Cancer Institute Cooperative Group Program Clinical Trials. Journal of Clinical Oncology 30(23):2869–2875.

Regnante, J. M., N. A. Richie, L. Fashoyin-Aje, M. Vichnin, M. Ford, U. B. Roy, K. Turner, L. L. Hall, E. Gonzalez, N. Esnaola, L. T. Clark, H. C. Adams 3rd, O. B. Alese, K. Gogineni, L. McNeill, D. Petereit, I. Sargeant, J. Dang, C. Obasaju, Q. Highsmith, S. C. Lee, S. C. Hoover, E. L. Williams, and M. S. Chen, Jr. 2019. U.S. cancer centers of excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. Journal of Oncology Practice 15(4):e289–e299.

Ross, J. S., J. Waldstreicher, S. Bamford, J. A. Berlin, K. Childers, N. R. Desai, G. Gamble, C. P. Gross, R. Kuntz, R. Lehman, P. Lins, S. A. Morris, J. D. Ritchie, and H. M. Krumholz. 2018. Overview and experience of the YODA Project with clinical trial data sharing after 5 years. Scientific Data 5:180268.

Solomon, S. D., J. J. McMurray, M. A. Pfeffer, J. Wittes, R. Fowler, P. Finn, W. F. Anderson, A. Zauber, E. Hawk, M. Bertagnolli, and the Adenoma Prevention with Celecoxib (APC) Study Investigators. 2005. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. New England Journal of Medicine 352(11):1071–1080.

Solomon, S. D., J. Wittes, P. V. Finn, R. Fowler, J. Viner, M. M. Bertagnolli, N. Arber, B. Levin, C. L. Meinert, B. Martin, J. L. Pater, P. E. Goss, P. Lance, S. Obara, E. Y. Chew, J. Kim, G. Arndt, E. Hawk, and the Cross Trial Safety Assessment Group. 2008. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: The Cross Trial safety analysis. Circulation 117(16):2104–2113.

SPRINT (Systolic Blood Pressure Intervention Trial) Research Group, J. T. Wright Jr., J. D. Williamson, P. K. Whelton, J. K. Snyder, K. M. Sink, M. V. Rocco, D. M. Reboussin, M. Rahman, S. Oparil, C. E. Lewis, P. L. Kimmel, K. C. Johnson, D. C. Goff, Jr., L. J. Fine, J. A. Cutler, W. C. Cushman, A. K. Cheung, and W. T. Ambrosius. 2015. A randomized trial of intensive versus standard blood-pressure control. New England Journal of Medicine 373(22):2103–2116.

Sydes, M. R., and D. Ashby. 2017. Data authorship as an incentive to data sharing. New England Journal of Medicine 377(4):402.

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Tudur Smith, C., S. Nevitt, D. Appelbe, R. Appleton, P. Dixon, J. Harrison, A. Marson, P. Williamson, and E. Tremain. 2017. Resource implications of preparing individual participant data from a clinical trial to share with external researchers. Trials 18(1):319.

van Den Eynden, V. G. Knight, A. Vlad, B. Radler, C. Tenopir, D. Leon, F. Manista, J. Whitworth, and L. Corti. 2016. Survey of Wellcome researchers and their attitudes to open research. Technical Report. https://researchonline.lshtm.ac.uk/id/eprint/3332696/1/TowardsOpenResearch.pdf (accessed February 10, 2020).

Varnai, P., M. C. Rentel., P. Simmonds., T. A. Sharp, B. Mostert, and T. de Jongh. 2014. Assessing the research potential of access to clinical trial data. A report to the Wellcome Trust. Technopolis Group (UK). https://wellcome.ac.uk/sites/default/files/assessing-research-potential-of-access-to-clinical-trials-data-wellcome-mar15.pdf (accessed February 10, 2020).

Zarin, D. A., and T. Tse. 2016. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLOS Medicine 13(1):e1001946.

Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×

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Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×
Page 123
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×
Page 124
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×
Page 125
Suggested Citation:"Appendix A: References." National Academies of Sciences, Engineering, and Medicine. 2020. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25838.
×
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On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.

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