Aernoud Fiolet

327 Text-mining in electronic healthcare records can be used for screening and data collection REFERENCES 1. The European medicines agency working group on clinical trials conducted outside of the EU/ EEA. Reflection Paper Ethical GCP Aspects Clin Trials Med Prod Hum Use Conducted Outside EU/EEA Submitted Marketing Au. www.ema.europa.eu (2012), Accessed 5th Jan 2020 2. U.S. Food and Drug Administration. Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry U. (2018). https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations- guidance-industry, Accessed 5th Jan 2020 3. T.J. Moore, H. Zhang, G. Anderson, G.C. Alexander. Estimated costs of pivotal trials for novel therapeutic agents approved by the US food and drug administration, 2015-2016. JAMA Intern Med, 178 (11) (2018), p. 145 4. S.D. Solomon, M.A. Pfeffer. The future of clinical trials in cardiovascular medicine. Circulation, 133 (2016), pp. 2662-2670 5. C. Bentley, S. Cressman, K. van der Hoek, K. Arts, J. Dancey, S. Peacock. Conducting clinical trials— costs, impacts, and the value of clinical trials networks: a scoping review. Clin Trials, 16 (2019), pp. 183-193 6. L. Martin, M. Hutchens, C. Hawkins, A. Radnov, How much do clinical trials cost?Nat Rev Drug Discov, 16 (6) (2017), pp. 381-382 7. M. McClellan, N. Brown, R.M. Califf, J.J.Warner. Call to action: urgent challenges in cardiovascular disease: a presidential advisory from the American heart association. Circulation (2019), pp. 1-11 8. Sertkaya, A. Birkenbach, A. Berlind, J. Eyraud. Examination of Clinical Trial Costs and Barriers for Drug Development. U.S. Department of Health and Human Services, Washington, DC (2014) 9. S.M. Meystre, C. Lovis, T. Bürkle, G. Tognola, A. Budrionis, C.U. Lehmann. Clinical data reuse or secondary use: current status and potential future progress. Yearb Med Inform, 26 (1) (2017), pp. 38-52 10. E. Ford, J.A. Carroll, H.E. Smith, D. Scott, J.A. Cassell. Extracting information from the text of electronic medical records to improve case detection: a systematic review. J Am Med Inform Assoc, 23 (5) (2016), pp. 1007-1015 11. K. Vantongelen, N. Rotmensz, E. Van Der Schueren. Quality control of validity of data collected in clinical trials. Eur J Cancer Clin Oncol, 25 (8) (1989), pp. 1241-1247 12. S.F. Chan, P. Macaskill, L. Irwig, S.D. Walter. Adjustment for baseline measurement error in randomized controlled trials induces bias. Control Clin Trials, 25 (2004), pp. 408-416 13. S.M. Nidorf, A.T.L. Fiolet, J.W. Eikelboom, A. Schut, T.S.J. Opstal, W.A. Bax, et al. The effect of low-dose colchicine in patients with stable coronary artery disease: the LoDoCo2 trial rationale, design, and baseline characteristics. Am Heart J, 218 (2019), pp. 46-56 14. S.M. Nidorf, A.T.L. Fiolet, A. Mosterd, J.W. Eikelboom, A. Schut, T.S.J. Opstal, et al. Colchicine in patients with chronic coronary disease. N Engl J Med (2020), pp. 1-10 15. KPMG. EHR vendor market. https://nchica.org/wp-content/uploads/2018/10/Eckert-Puls.pdf (2018), Accessed 26th Sep 2019 16. Zorgvisie. Het complete epd-overzicht: welk ziekenhuis heeft welke leverancier? – Zorgvisie. https://www.zorgvisie.nl/epd-overzicht/ , Accessed 1st Oct 2019 17. P. Coorevits, M. Sundgren, G.O. Klein, A. Bahr, B. Claerhout, C. Daniel, et al. Electronic health records: new opportunities for clinical research. J Intern Med, 274 (6) (2013), pp. 547-560