1. Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the gold standard—lessons from the history of RCTs. N Engl J Med. 2016;374(22):2175-81.
2. Kovesdy CP. Clinical trials in end-stage renal disease—priorities and challenges. Nephrology Dialysis Transplantation. 2019;34(7):1084-9.
3. Bryan L, Ibrahim T, Zent R, Fischer MJ. The kidney research predicament. Journal of the American Society of Nephrology. 2014;25(5):898–903.
4. Baigent C, Herrington WG, Coresh J, Landray MJ, Levin A, Perkovic V, et al. Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference. Kidney international. 2017;92(2):297–305.
5. Fröbert O, Lagerqvist B, Gudnason T, Thuesen L, Svensson R, Olivecrona GK, et al. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. 2010;160(6):1042-8.
6. Li G, Sajobi TT, Menon BK, Korngut L, Lowerison M, James M, et al. Registry-based randomized controlled trials-what are the advantages, challenges, and areas for future research? 2016;80:16–24.
7. Mathes T, Buehn S, Prengel P, Pieper DJJoce. Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. 2018;93:120-7.
8. Yndigegn T, Hofmann R, Jernberg T, Gale CP, Kardiologi, Cardiology, et al. Registry-based randomised clinical trial: efficient evaluation of generic pharmacotherapies in the contemporary era. Heart. 2018;104(19):1562-7.
9. Hoque DME, Kumari V, Hoque M, Ruseckaite R, Romero L, Evans SMJPo. Impact of clinical registries on quality of patient care and clinical outcomes: A systematic review. 2017;12(9):e0183667.
10. Sørensen HTJIJoR, Medicine Si. Regional administrative health registries as a resource in clinical epidemiology. 1997;10(1):1–22.
11. Nyberg K, Hedman P. Swedish guidelines for registry-based randomized clinical trials. Upsala Journal of Medical Sciences. 2019;124(1):33 − 6.
12. Foroughi S, Wong H-l, Gately L, Lee M, Simons K, Tie J, et al. Re-inventing the randomized controlled trial in medical oncology: The registry-based trial. 2018;14(6):365 − 73.
13. Lund LH, Oldgren J, James SJCHFR. Registry-Based Pragmatic Trials in Heart Failure: Current Experience and Future Directions. 2017;14(2):59–70.
14. James S, Rao SV, Granger CB. Registry-based randomized clinical trials—a new clinical trial paradigm. Nature Reviews Cardiology. 2015;12:312.
15. Lauer MS, D’Agostino Sr RBJNEJM. The randomized registry trial—the next disruptive technology in clinical research. 2013;369(17):1579-81.
16. James S, Fröbert O, Lagerqvist B. Cardiovascular registries: a novel platform for randomised clinical trials. BMJ Publishing Group Ltd and British Cardiovascular Society; 2012.
17. Heyland DK, Patel J, Bear D, Sacks G, Nixdorf H, Dolan J, et al. The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-Based Randomized Trial: The EFFORT Trial. 2019;43(3):326 − 34.
18. Foroughi S, Wong Hl, Gately L, Lee M, Simons K, Tie J, et al. Registry-based randomized clinical trials as a method to improve cancer care in Australia. Asia‐Pacific Journal of Clinical Oncology. 2019;15(3):188-9.
19. Ellis PM. Attitudes towards and participation in randomised clinical trials in oncology: A review of the literature. Annals of Oncology. 2000;11(8):939 − 45.
20. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott RJJoce. Barriers to participation in randomised controlled trials: a systematic review. 1999;52(12):1143-56.
21. Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. 2013;3(2):e002360.
22. Kirkby HM, Calvert M, Draper H, Keeley T, Wilson SJBo. What potential research participants want to know about research: a systematic review. 2012;2(3):e000509.
23. Wendler D, Grady CJB. What should research participants understand to understand they are participants in research? 2008;22(4):203-8.
24. Hall AE, Sanson-Fisher RW, Lynagh MC, Threlfall T, D'Este CA. Format and readability of an enhanced invitation letter did not affect participation rates in a cancer registry-based study: a randomized controlled trial. Journal of Clinical Epidemiology. 2013;66(1):85–94.
25. Healy P, Galvin S, Williamson PR, Treweek S, Whiting C, Maeso B, et al. Identifying trial recruitment uncertainties using a James Lind Alliance priority setting partnership–the PRioRiTy (Prioritising recruitment in randomised trials) study. Trials. 2018;19(1):147.
26. Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane database of systematic reviews. 2018(2).
27. von Elm E, Altman D, Egger M, Pocock S, Gotzsche P, Vandenbroucke J. The Strengthening and Reporting of Observational Studies in Epidemiology (STROBE) Statement guidelines for observational studies.
28. Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Patients' perceptions of written consent: questionnaire study. Bmj. 2006;333(7567):528.
29. Court EL, Robinson JA, Hocken DB. Informed consent and patient understanding of blood transfusion. Transfusion Medicine. 2011;21(3):183-9.
30. Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ journal of surgery. 2014;84(4):207 − 10.
31. Tam NT, Huy NT, Thoa LTB, Long NP, Trang NTH, Hirayama K, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bulletin of the World Health Organization. 2015;93:186-98H.
32. Locock L, Smith L. Personal experiences of taking part in clinical trials – A qualitative study. Patient Education and Counseling. 2011;84(3):303-9.
33. Montalvo W, Larson E. Participant comprehension of research for which they volunteer: a systematic review. Journal of Nursing Scholarship. 2014;46(6):423 − 31.
34. Hereu P, Pérez E, Fuentes I, Vidal X, Suñé P, Arnau JM. Consent in clinical trials: What do patients know? Contemporary Clinical Trials. 2010;31(5):443-6.
35. Hietanen P, Aro AR, Holli K, Absetz P. Information and communication in the context of a clinical trial. European Journal of Cancer. 2000;36(16):2096 − 104.
36. Ellis PM, Dowsett SM, Butow PN, Tattersall MHN. Attitudes to randomized clinical trials amongst out-patients attending a medical oncology clinic. Health Expectations. 1999;2(1):33–43.
37. Kelly CM, Feighery R, McCaffrey J, Higgins M, Smith M, O'Reilly S, et al. 1465P_PR - Do oncology patients understand clinical trials? A nationwide study by Cancer Trials Ireland. Annals of Oncology. 2017;28:v643-v4.
38. Voigt P, Von dem Bussche A. The eu general data protection regulation (gdpr). A Practical Guide, 1st Ed, Cham: Springer International Publishing. 2017.
39. Parliament E. Regulation (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC In: Parliament E, ed. EC text with EEA relevance. 2014.
40. Jenkins V, Farewell V, Farewell D, Darmanin J, Wagstaff J, Langridge C, et al. Drivers and barriers to patient participation in RCTs. British journal of cancer. 2013;108(7):1402-7.
41. Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. British journal of cancer. 2000;82(11):1783-8.
42. Carroll R, Antigua J, Taichman D, Palevsky H, Forfia P, Kawut S, et al. Motivations of patients with pulmonary arterial hypertension to participate in randomized clinical trials. Clinical Trials. 2012;9(3):348 − 57.
43. Lynöe N, Näsström B, Sandlund M. Study of the Quality of Information Given to Patients Participating in a Clinical Trial Regarding Chronic Hemodialysis. Scandinavian Journal of Urology and Nephrology. 2004;38(6):517 − 20.
44. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. Journal of internal medicine. 2002;251(2):156 − 68.
45. Udrea G, Dumitrescu B, Purcarea M, Balan I, Rezus E, Deculescu D. Patients' perspectives and motivators to participate in clinical trials with novel therapies for rheumatoid arthritis. Journal of medicine and life. 2009;2(2):227.
46. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, et al. Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors. The Lancet Oncology. 2006;7(2):141-8.
47. Nurgat ZA, Craig W, Campbell NC, Bissett JD, Cassidy J, Nicolson MC. Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. British Journal of Cancer. 2005;92(6):1001-5.
48. Kadam RA, Borde SU, Madas SA, Salvi SS, Limaye SS. Challenges in recruitment and retention of clinical trial subjects. Perspectives in clinical research. 2016;7(3):137.
49. Ferguson PR. Patients' perceptions of information provided in clinical trials. Journal of Medical Ethics. 2002;28(1):45 − 8.
50. Martin SS, Ou F-S, Newby LK, Sutton V, Adams P, Felker GM, et al. Patient-and trial-specific barriers to participation in cardiovascular randomized clinical trials. Journal of the American College of Cardiology. 2013;61(7):762-9.
51. Walsh E, Sheridan A. Factors affecting patient participation in clinical trials in Ireland: A narrative review. Contemporary Clinical Trials Communications. 2016;3:23–31.
52. Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. Journal of clinical nursing. 2010;19(1-2):227 − 33.
53. Ross S, Grant A, Counsell C, Gillespie W, Russell I, Prescott R. Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143-56.
54. Stead M, Eadie D, Gordon D, Angus K. “Hello, hello—it’s English I speak!”: a qualitative exploration of patients’ understanding of the science of clinical trials. Journal of Medical Ethics. 2005;31(11):664-9.
55. Griffin JM, Struve JK, Collins D, Liu A, Nelson DB, Bloomfield HE. Long term clinical trials: how much information do participants retain from the informed consent process? Contemporary clinical trials. 2006;27(5):441-8.