Data sharing in clinical trials: An experience with two large cancer screening trials

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Paul Pinsky of the US National Cancer Institute and colleagues describe the implementation and outcomes of web-based data sharing from the PLCO and NLST cancer screening trials.

Vyšlo v časopise: Data sharing in clinical trials: An experience with two large cancer screening trials. PLoS Med 14(5): e32767. doi:10.1371/journal.pmed.1002304
Kategorie: Health in Action
prolekare.web.journal.doi_sk: https://doi.org/10.1371/journal.pmed.1002304

Souhrn

Paul Pinsky of the US National Cancer Institute and colleagues describe the implementation and outcomes of web-based data sharing from the PLCO and NLST cancer screening trials.

Zdroje

1. Instute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington, DC: 2015.

2. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing Clinical Trial Data—A Proposal from the International Committee of Medical Journal Editors. New England Journal of Medicine. 2016;374(4):384–6. doi: 10.1056/NEJMe1515172 26786954

3. Giffen CA, Carroll LE, Adams JT, Brennan SP, Coady SA, Wagner EL. Providing Contemporary Access to Historical Biospecimen Collections: Development of the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). Biopreservation and biobanking. 2015;13(4):271–9. doi: 10.1089/bio.2014.0050 26186276

4. Krumholz HM, Waldstreicher J. The Yale Open Data Access (YODA) Project—A Mechanism for Data Sharing. The New England journal of medicine. 2016;375(5):403–5. doi: 10.1056/NEJMp1607342 27518657

5. Navar AM, Pencina MJ, Rymer JA, Louzao DM, Peterson ED. Use of Open Access Platforms for Clinical Trial Data. Jama. 2016;315(12):1283–4. doi: 10.1001/jama.2016.2374 27002452

6. Pencina MJ, Louzao DM, McCourt BJ, Adams MR, Tayyabkhan RH, Ronco P, et al. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. American heart journal. 2016;172:64–9. doi: 10.1016/j.ahj.2015.11.002 26856217

7. Green AK, Reeder-Hayes KE, Corty RW, Basch E, Milowsky MI, Dusetzina SB, et al. The project data sphere initiative: accelerating cancer research by sharing data. The oncologist. 2015;20(5):464–e20. doi: 10.1634/theoncologist.2014-0431 25876994

8. Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, et al. Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up. Journal of the National Cancer Institute. 2012;104(2):125–32. doi: 10.1093/jnci/djr500 22228146

9. Oken MM, Hocking WG, Kvale PA, Andriole GL, Buys SS, Church TR, et al. Screening by chest radiograph and lung cancer mortality: the Prostate, Lung, Colorectal, and Ovarian (PLCO) randomized trial. Jama. 2011;306(17):1865–73. doi: 10.1001/jama.2011.1591 22031728

10. Schoen RE, Pinsky PF, Weissfeld JL, Yokochi LA, Church T, Laiyemo AO, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. The New England journal of medicine. 2012;366(25):2345–57. doi: 10.1056/NEJMoa1114635 22612596

11. Buys SS, Partridge E, Black A, Johnson CC, Lamerato L, Isaacs C, et al. Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial. Jama. 2011;305(22):2295–303. doi: 10.1001/jama.2011.766 21642681

12. Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, et al. Reduced lung-cancer mortality with low-dose computed tomographic screening. The New England journal of medicine. 2011;365(5):395–409. doi: 10.1056/NEJMoa1102873 21714641

13. Zhu CS, Pinsky PF, Kramer BS, Prorok PC, Purdue MP, Berg CD, et al. The prostate, lung, colorectal, and ovarian cancer screening trial and its associated research resource. Journal of the National Cancer Institute. 2013;105(22):1684–93. doi: 10.1093/jnci/djt281 24115361

14. Coady SA, Mensah GA, Wagner EL, Goldfarb ME, Hitchcock DM, Giffen CA. Use of the National Heart, Lung, and Blood Institute Data Repository. New England Journal of Medicine. 2017. E-pub ahead of print.

15. Bertagnolli MM, Sartor O, Chabner BA, Rothenberg ML, Khozin S, Hugh-Jones C, et al. Advantages of a Truly Open-Access Data-Sharing Model. The New England journal of medicine. 2017;376(12):1178–81. doi: 10.1056/NEJMsb1702054 28328337

16. Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, et al. Sharing of clinical trial data among trialists: a cross sectional survey. BMJ (Clinical research ed). 2012;345:e7570.

17. Strom BL, Buyse ME, Hughes J, Knoppers BM. Data Sharing—Is the Juice Worth the Squeeze? The New England journal of medicine. 2016;375(17):1608–9. doi: 10.1056/NEJMp1610336 27783903