Aernoud Fiolet

350 Chapter 14 REFERENCES 1. Speich B, von Niederhäusern B, Schur N, et al. Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data. J Clin Epidemiol. 2018;96:1-11. 2. Moore TJ, Zhang H, Anderson G, Alexander GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med. 2018;178(11):1451. 3. VanNormanGA.Overcoming theDecliningTrends inInnovationandInvestment inCardiovascular Therapeutics: Beyond EROOM’s Law. JACC Basic to Transl Sci. 2017;2(5):613-625. 4. Scannell JW, Blanckley A, Boldon H, Warrington B. Diagnosing the decline in pharmaceutical R&D efficiency. Nat Rev Drug Discov. 2012;11(3):191-200. 5. Djurisic S, Rath A, Gaber S, et al. Barriers to the conduct of randomised clinical trials within all disease areas. Trials. 2017;18(1):360. 6. Sertkaya A, Birkenbach A, Berlind A, Eyraud J. Examination of Clinical Trial Costs and Barriers for Drug Development. Lexington; 2014. 7. Munos B. Lessons from 60 years of pharmaceutical innovation. Nat Rev Drug Discov. 2009;8(12):959-968. 8. Martin L, Hutchens M, Hawkins C, Radnov A. How much do clinical trials cost? Nat Rev Drug Discov. 2017;16(6):381-382. doi:10.1038/nrd.2017.70 9. McCord KA, Al-Shahi Salman R, Treweek S, et al. Routinely collected data for randomized trials: Promises, barriers, and implications. Trials. 2018;19(1). 10. van Dijk WB, Fiolet ATL, Schuit E, et al. Text-mining in electronic healthcare records can be used as efficient tool for screening and data-collection in cardiovascular trials: a multicenter validation study. J Clin Epidemiol. 2020;132(1):97-105. 11. Lensen S, Macnair A, Love SB, et al. Access to routinely collected health data for clinical trials - Review of successful data requests to UK registries. Trials. 2020;21(1):398. 12. Vantongelen K, Rotmensz N, Van Der Schueren E. Quality control of validity of data collected in clinical trials. Eur J Cancer Clin Oncol. 1989;25(8):1241-1247. doi:10.1016/0277- 5379(89)90421-5 13. Kjøller E, Hilden J,Winkel P, et al. Agreement between public register and adjudication committee outcome in a cardiovascular randomized clinical trial. Am Heart J. 2014;168(2):197--204.e4. doi:10.1016/j.ahj.2013.12.032 14. St. PeterWL, Liu J,Weinhandl E, FanQ.AComparison of Sevelamer and Calcium-Based Phosphate Binders on Mortality, Hospitalization, and Morbidity in Hemodialysis: A Secondary Analysis of the Dialysis Clinical Outcomes Revisited (DCOR) Randomized Trial Using Claims Data. Am J Kidney Dis. 2008;51(3):445-454. 15. Nidorf SM, Fiolet ATL, Mosterd A, et al. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020:1-10. doi:10.1056/NEJMoa2021372 16. Nidorf SM, Fiolet ATL, Eikelboom JW, 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. 2019;218:46-56. doi:10.1016/j.ahj.2019.09.011 17. KPMG. The MedTechMarket in the Netherlands.; 2017. https://assets.kpmg/content/dam/kpmg/ nl/pdf/2018/sector/farmaceutische-industrie/the-medtech-market-in-the-netherlands.pdf.

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