National Academies Press: OpenBook
« Previous: 9 Looking Forward: Incentivizing Data Sharing and Reuse
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.
×

Appendix A

References

ART (Anturane Reinfarction Trial) Research Group. 1980. Sulfinpyrazone in the prevention of sudden death after myocardial infarction. New England Journal of Medicine 302(5):250–256.

Baggerly, K. A., and K. R. Coombes. 2009. Deriving chemosensitivity from cell lines: Forensic bioinformatics and reproducible research in high-throughput biology. Annals of Applied Statistics 3(4):1309–1334.

Baron, J. A., R. S. Sandler, R. S. Bresalier, A. Lanas, D. G. Morton, R. Riddell, E. R. Iverson, and D. L. Demets. 2008. Cardiovascular events associated with rofecoxib: Final analysis of the APPROVe trial. Lancet 372(9651):1756–1764.

Bertagnolli, M. M., O. Sartor, B. A. Chabner, M. L. Rothenberg, S. Khozin, C. Hugh-Jones, D. M. Reese, and M. J. Murphy. 2017. Advantages of a truly open-access data-sharing model. New England Journal of Medicine 376(12):1178–1181.

Bresalier, R. S., R. S. Sandler, H. Quan, J. A. Bolognese, B. Oxenius, K. Horgan, C. Lines, R. Riddell, D. Morton, A. Lanas, M. A. Konstam, J. A. Baron, and the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. 2005. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. New England Journal of Medicine 352(11):1092–1102.

Bristow, M. R., L. A. Saxon, J. Boehmer, S. Krueger, D. A. Kass, T. De Marco, P. Carson, L. DiCarlo, D. DeMets, B. G. White, D. W. DeVries, A. M. Feldman, and Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. 2004. Cardiac resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. New England Journal of Medicine 350:2140–2150.

Corbett, M., F. Chehadah, M. Biswas, T. Moe-Byrne, S. Palmer, M. Soares, M. Walton, M. Harden, P. Ho, N. Woolacott, and L. Bojke. 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis following inadequate response to disease-modifying antirheumatic drugs: A systematic review and economic evaluation. Health Technology Assessment 21(56):1–326.

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.

Gamble, C., A. Krishan, D. Stocken, S. Lewis, E. Juszczak, C. Doré, P. R. Williamson, D. G. Altman, A. Montgomery, P. Lim, J. Berlin, S. Senn, S. Day, Y. Barbachano, and E. Loder. 2017. Guidelines for the content of statistical analysis plans in clinical trials. JAMA 318(23):2337–2343.

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.

Gritz, E. R., C. Dresler, and L. Sarna. 2005. Smoking, the missing drug interaction in clinical trials: Ignoring the obvious. Cancer Epidemiology, Biomarkers & Prevention 14(10):2287–2293.

IOM (Institute of Medicine). 2012a. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012b. Evolution of translational omics: Lessons learned and the path forward. Washington, DC: The National Academies Press.

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.

Kratz, J. E., and C. Strasser. 2015. Researcher perspectives on publication and peer review of data. PLOS ONE 10(2):e0117619.

Kush, R. D. 2014. What the patient should order. Science Translational Medicine 1(3):3cm3.

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.

Temple, R., and G. W. Pledger. 1980. The FDA’s critique of the Anturane Reinfarction Trial. New England Journal of Medicine 303(25):1488–1492.

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.
×

This page intentionally left blank.

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.
×
Page 126
Next: Appendix B: Workshop Agenda »
Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop Get This Book
×
Buy Paperback | $70.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!