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Items: 49

1.

Responsible data sharing in a big data-driven translational research platform: lessons learned.

Kalkman S, Mostert M, Udo-Beauvisage N, van Delden JJ, van Thiel GJ.

BMC Med Inform Decis Mak. 2019 Dec 30;19(1):283. doi: 10.1186/s12911-019-1001-y.

2.

The moral and legal status of Health Care Workers in Cluster Randomized Trials: a response to Weijer and Taljaard.

van der Graaf R, van Thiel GJMW, Hoop EO, Moons KGM, Grobbee DE, van Delden JJM.

J Clin Epidemiol. 2019 Dec;116:146-149. doi: 10.1016/j.jclinepi.2019.08.005. Epub 2019 Aug 23.

PMID:
31449856
3.

Regulatory sanctions for ethically relevant GCP violations.

Bernabe RC, van Thiel GJMW, Breekveldt NS, Gispen CC, van Delden JJM.

Drug Discov Today. 2019 Nov;24(11):2116-2119. doi: 10.1016/j.drudis.2019.07.001. Epub 2019 Jul 6.

4.

Narrative medicine as a medical education tool: A systematic review.

Milota MM, van Thiel GJMW, van Delden JJM.

Med Teach. 2019 Jul;41(7):802-810. doi: 10.1080/0142159X.2019.1584274. Epub 2019 Apr 14.

PMID:
30983460
5.

Responsible data sharing in international health research: a systematic review of principles and norms.

Kalkman S, Mostert M, Gerlinger C, van Delden JJM, van Thiel GJMW.

BMC Med Ethics. 2019 Mar 28;20(1):21. doi: 10.1186/s12910-019-0359-9.

6.

Developments in euthanasia practice in the Netherlands: Balancing professional responsibility and the patient's autonomy.

Kouwenhoven PSC, van Thiel GJMW, van der Heide A, Rietjens JAC, van Delden JJM.

Eur J Gen Pract. 2019 Jan;25(1):44-48. doi: 10.1080/13814788.2018.1517154. Epub 2018 Nov 1.

7.

Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports.

Bernabe RDLC, van Thiel GJMW, Breekveldt NS, Gispen-de Wied CC, van Delden JJM.

Curr Med Res Opin. 2019 Apr;35(4):637-645. doi: 10.1080/03007995.2018.1528214. Epub 2018 Oct 29.

PMID:
30252539
8.

Pragmatic clinical trials: ethical imperatives and opportunities.

Kalkman S, van Thiel GJMW, Grobbee DE, van Delden JJM.

Drug Discov Today. 2018 Dec;23(12):1919-1921. doi: 10.1016/j.drudis.2018.06.007. Epub 2018 Jun 12. No abstract available.

PMID:
29906514
9.

Treatment restrictions in patients with severe stroke are associated with an increased risk of death.

Geurts M, de Kort FA, de Kort PL, van Tuijl JH, van Thiel GJ, Kappelle LJ, van der Worp HB.

Eur Stroke J. 2017 Sep;2(3):244-249. doi: 10.1177/2396987317704546. Epub 2017 Apr 10.

10.

Big data from electronic health records for early and late translational cardiovascular research: challenges and potential.

Hemingway H, Asselbergs FW, Danesh J, Dobson R, Maniadakis N, Maggioni A, van Thiel GJM, Cronin M, Brobert G, Vardas P, Anker SD, Grobbee DE, Denaxas S; Innovative Medicines Initiative 2nd programme, Big Data for Better Outcomes, BigData@Heart Consortium of 20 academic and industry partners including ESC.

Eur Heart J. 2018 Apr 21;39(16):1481-1495. doi: 10.1093/eurheartj/ehx487. Review.

11.

Advance directives, proxy opinions, and treatment restrictions in patients with severe stroke.

de Kort FAS, Geurts M, de Kort PLM, van Tuijl JH, van Thiel GJMW, Kappelle LJ, van der Worp HB.

BMC Palliat Care. 2017 Nov 14;16(1):52. doi: 10.1186/s12904-017-0234-8.

12.

The ambivalent place of ethics in European regulatory documents.

Bernabe RDLC, van Thiel GJMW, Gispen CC, Breekveldt NS, van Delden JJM.

Drug Discov Today. 2018 Feb;23(2):205-207. doi: 10.1016/j.drudis.2017.10.011. Epub 2017 Oct 27. No abstract available.

13.

Ethics of Informed Consent for Pragmatic Trials with New Interventions.

Kalkman S, Kim SYH, van Thiel GJMW, Grobbee DE, van Delden JJM.

Value Health. 2017 Jul - Aug;20(7):902-908. doi: 10.1016/j.jval.2017.04.005. Epub 2017 May 16.

14.

Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators.

Zuidgeest MGP, Welsing PMJ, van Thiel GJMW, Ciaglia A, Alfonso-Cristancho R, Eckert L, Eijkemans MJC, Egger M; WP3 of the GetReal consortium.

J Clin Epidemiol. 2017 Oct;90:92-98. doi: 10.1016/j.jclinepi.2017.07.001. Epub 2017 Jul 8.

15.

Series: Pragmatic trials and real world evidence: Paper 1. Introduction.

Zuidgeest MGP, Goetz I, Groenwold RHH, Irving E, van Thiel GJMW, Grobbee DE; GetReal Work Package 3.

J Clin Epidemiol. 2017 Aug;88:7-13. doi: 10.1016/j.jclinepi.2016.12.023. Epub 2017 May 24.

16.

Series: Pragmatic trials and real world evidence: Paper 4. Informed consent.

Kalkman S, van Thiel GJMW, Zuidgeest MGP, Goetz I, Pfeiffer BM, Grobbee DE, van Delden JJM; Work Package 3 of the IMI GetReal Consortium.

J Clin Epidemiol. 2017 Sep;89:181-187. doi: 10.1016/j.jclinepi.2017.03.019. Epub 2017 May 11.

17.

Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

Kalkman S, van Thiel GJ, Grobbee DE, Meinecke AK, Zuidgeest MG, van Delden JJ; Work Package 3 of the IMI GetReal Consortium.

Trials. 2016 Aug 22;17(1):419. doi: 10.1186/s13063-016-1546-3.

18.

What do international ethics guidelines say in terms of the scope of medical research ethics?

Bernabe RD, van Thiel GJ, van Delden JJ.

BMC Med Ethics. 2016 Apr 26;17:23. doi: 10.1186/s12910-016-0106-4.

19.

Participatory methods in pediatric participatory research: a systematic review.

Haijes HA, van Thiel GJ.

Pediatr Res. 2016 May;79(5):676-83. doi: 10.1038/pr.2015.279. Epub 2015 Dec 31. Review.

PMID:
26720607
20.

Drug regulators and ethics: which GCP issues are also ethical issues?

Bernabe RD, van Thiel GJ, Breekveldt NS, van Delden JJ.

Drug Discov Today. 2016 Feb;21(2):217-24. doi: 10.1016/j.drudis.2015.11.006. Epub 2015 Nov 21.

PMID:
26610417
21.

A systematic review of reasons for gatekeeping in palliative care research.

Kars MC, van Thiel GJ, van der Graaf R, Moors M, de Graeff A, van Delden JJ.

Palliat Med. 2016 Jun;30(6):533-48. doi: 10.1177/0269216315616759. Epub 2015 Nov 17. Review.

PMID:
26577927
22.

The ethics of cluster-randomized trials requires further evaluation: a refinement of the Ottawa Statement.

van der Graaf R, Koffijberg H, Grobbee DE, de Hoop E, Moons KG, van Thiel GJ, de Wit GA, van Delden JJ.

J Clin Epidemiol. 2015 Sep;68(9):1108-14. doi: 10.1016/j.jclinepi.2015.03.013. Epub 2015 Mar 27.

PMID:
25910909
23.

Pragmatic randomized trials in drug development pose new ethical questions: a systematic review.

Kalkman S, van Thiel GJ, Grobbee DE, van Delden JJ.

Drug Discov Today. 2015 Jul;20(7):856-62. doi: 10.1016/j.drudis.2015.03.005. Epub 2015 Mar 17. Review.

PMID:
25794600
24.

[Timing of Advance Care Planning in frail elderly patients: when to start?].

Ott B, van Thiel GJ, de Ruiter CM, van Delden HJ.

Ned Tijdschr Geneeskd. 2015;159:A8295. Review. Dutch.

PMID:
25650032
25.

Opinions about euthanasia and advanced dementia: a qualitative study among Dutch physicians and members of the general public.

Kouwenhoven PS, Raijmakers NJ, van Delden JJ, Rietjens JA, van Tol DG, van de Vathorst S, de Graeff N, Weyers HA, van der Heide A, van Thiel GJ.

BMC Med Ethics. 2015 Jan 28;16:7. doi: 10.1186/1472-6939-16-7.

26.

Patient representatives' contributions to the benefit-risk assessment tasks of the European Medicines Agency scientific committees.

Bernabe RD, van Thiel GJ, van Delden J.

Br J Clin Pharmacol. 2014 Dec;78(6):1248-56. doi: 10.1111/bcp.12456. Review.

27.

['Best proven care' not always the best control].

van der Graaf R, van Thiel GJ, van Delden JJ.

Ned Tijdschr Geneeskd. 2014;158:A7227; discussion A7227. Dutch.

PMID:
24690518
28.

End-of-life decisions in patients with severe acute brain injury.

Geurts M, Macleod MR, van Thiel GJ, van Gijn J, Kappelle LJ, van der Worp HB.

Lancet Neurol. 2014 May;13(5):515-24. doi: 10.1016/S1474-4422(14)70030-4. Epub 2014 Mar 25. Review.

PMID:
24675048
29.

The fiduciary obligation of the physician-researcher in phase IV trials.

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ.

BMC Med Ethics. 2014 Feb 7;15:11. doi: 10.1186/1472-6939-15-11.

30.

Euthanasia or physician-assisted suicide? A survey from the Netherlands.

Kouwenhoven PS, van Thiel GJ, Raijmakers NJ, Rietjens JA, van der Heide A, van Delden JJ.

Eur J Gen Pract. 2014 Mar;20(1):25-31. doi: 10.3109/13814788.2013.813014. Epub 2013 Dec 20.

PMID:
24359112
31.

Assistance in dying for older people without a serious medical condition who have a wish to die: a national cross-sectional survey.

Raijmakers NJ, van der Heide A, Kouwenhoven PS, van Thiel GJ, van Delden JJ, Rietjens JA.

J Med Ethics. 2015 Feb;41(2):145-50. doi: 10.1136/medethics-2012-101304. Epub 2013 Dec 13.

PMID:
24335917
32.

Non-physician-assisted suicide in The Netherlands: a cross-sectional survey among the general public.

Schoonman MK, van Thiel GJ, van Delden JJ.

J Med Ethics. 2014 Dec;40(12):842-8. doi: 10.1136/medethics-2013-101736. Epub 2013 Dec 5.

PMID:
24310169
33.

Restoring trust in the pharmaceutical sector on the basis of the SSRI case.

Hernandez JF, van Thiel GJ, Mantel-Teeuwisse AK, Raaijmakers JA, Pieters T.

Drug Discov Today. 2014 May;19(5):523-7. doi: 10.1016/j.drudis.2013.11.019. Epub 2013 Dec 1. Review.

PMID:
24295641
34.

Involvement of the Dutch general population in advance care planning: a cross-sectional survey.

Raijmakers NJ, Rietjens JA, Kouwenhoven PS, Vezzoni C, van Thiel GJ, van Delden JJ, van der Heide A.

J Palliat Med. 2013 Sep;16(9):1055-61. doi: 10.1089/jpm.2012.0555. Epub 2013 Jun 14.

PMID:
23767949
35.

Phase IV non-inferiority trials and additional claims of benefit.

Bernabe RD, Wangge G, Knol MJ, Klungel OH, van Delden JJ, de Boer A, Hoes AW, Raaijmakers JA, van Thiel GJ.

BMC Med Res Methodol. 2013 May 30;13:70. doi: 10.1186/1471-2288-13-70.

36.

News media coverage of euthanasia: a content analysis of Dutch national newspapers.

Rietjens JA, Raijmakers NJ, Kouwenhoven PS, Seale C, van Thiel GJ, Trappenburg M, van Delden JJ, van der Heide A.

BMC Med Ethics. 2013 Mar 6;14:11. doi: 10.1186/1472-6939-14-11.

37.

A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK.

Hernandez JF, Mantel-Teeuwisse AK, van Thiel GJ, Belitser SV, Warmerdam J, de Valk V, Raaijmakers JA, Pieters T.

PLoS One. 2012;7(9):e45515. doi: 10.1371/journal.pone.0045515. Epub 2012 Sep 20.

38.

Decision theory and the evaluation of risks and benefits of clinical trials.

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ.

Drug Discov Today. 2012 Dec;17(23-24):1263-9. doi: 10.1016/j.drudis.2012.07.005. Epub 2012 Jul 20.

PMID:
22819925
39.

Opinions of health care professionals and the public after eight years of euthanasia legislation in the Netherlands: a mixed methods approach.

Kouwenhoven PS, Raijmakers NJ, van Delden JJ, Rietjens JA, Schermer MH, van Thiel GJ, Trappenburg MJ, van de Vathorst S, van der Vegt BJ, Vezzoni C, Weyers H, van Tol DG, van der Heide A.

Palliat Med. 2013 Mar;27(3):273-80. doi: 10.1177/0269216312448507. Epub 2012 Jun 13.

PMID:
22695742
40.

Consent in psychiatric biobanks for pharmacogenetic research.

van der Baan FH, Bernabe RD, Bredenoord AL, Gregoor JG, Meynen G, Knol MJ, van Thiel GJ.

Int J Neuropsychopharmacol. 2013 Apr;16(3):677-82. doi: 10.1017/S146114571200048X. Epub 2012 May 21. Review.

PMID:
22607776
41.

The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods.

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ.

BMC Med Ethics. 2012 Apr 20;13:6. doi: 10.1186/1472-6939-13-6.

42.

Publication trends in newspapers and scientific journals for SSRIs and suicidality: a systematic longitudinal study.

Hernandez JF, Mantel-Teeuwisse AK, van Thiel GJ, Belitser SV, Raaijmakers JA, Pieters T.

BMJ Open. 2011 Dec 6;1(2):e000290. doi: 10.1136/bmjopen-2011-000290. Print 2011.

43.

Is informed consent necessary for randomized Phase IV 'observational' drug studies?

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ.

Drug Discov Today. 2011 Sep;16(17-18):751-4. doi: 10.1016/j.drudis.2011.06.007. Epub 2011 Jun 29.

PMID:
21741495
44.

Informed consent and phase IV non-interventional drug research.

Bernabe RD, van Thiel GJ, van Delden JJ, Raaijmakers JA.

Curr Med Res Opin. 2011 Mar;27(3):513-8. doi: 10.1185/03007995.2010.546393. Epub 2011 Jan 6.

PMID:
21208152
45.

The need to explicate the ethical evaluation tools to avoid ethical inflation.

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ.

Am J Bioeth. 2009 Nov;9(11):56-8. doi: 10.1080/15265160903197606. No abstract available.

PMID:
19882462
46.

The justificatory power of moral experience.

van Thiel GJ, van Delden JJ.

J Med Ethics. 2009 Apr;35(4):234-7. doi: 10.1136/jme.2008.026559.

PMID:
19332580
47.

Phase IV research: innovation in need of ethics.

van Thiel GJ, van Delden JJ.

J Med Ethics. 2008 Jun;34(6):415-6. doi: 10.1136/jme.2007.023911. No abstract available.

PMID:
18511610
48.

The principle of respect for autonomy in the care of nursing home residents.

van Thiel GJ, van Delden JJ.

Nurs Ethics. 2001 Sep;8(5):419-31.

PMID:
16004096
49.

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