Works by Bernabe, Rosemarie D L C

Results: 13

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

Published in:

BMC Medical Research Methodology, 2013, v. 13, n. 1, p. 1, doi. 10.1186/1471-2288-13-70

By:

Bernabe, Rosemarie D. L. C.;
Wangge, Grace;
Knol, Mirjam J.;
Klungel, Olaf H.;
Van Delden, Johannes J. M.;
de Boer, Anthonius;
Hoes, Arno W.;
Raaijmakers, Jan A. M.;
Van Thiel, Ghislaine J. M. W.

Publication type:

Article

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

Published in:

2013

By:

Bernabe, Rosemarie Dlc;
Wangge, Grace;
Knol, Mirjam J;
Klungel, Olaf H;
van Delden, Johannes Jm;
de Boer, Anthonius;
Hoes, Arno W;
Raaijmakers, Jan Am;
van Thiel, Ghislaine Jmw;
Bernabe, Rosemarie D L C;
van Delden, Johannes J M;
Raaijmakers, Jan A M;
van Thiel, Ghislaine J M W

Publication type:

journal article

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

Published in:

BMC Medical Ethics, 2014, v. 15, n. 1, p. 1, doi. 10.1186/1472-6939-15-11

By:

Bernabe, Rosemarie D. L. C.;
Van Thiel, Ghislaine J. M. W.;
Raaijmakers, Jan A. M.;
Van Delden, Johannes J. M.

Publication type:

Article

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

Published in:

2014

By:

Bernabe, Rosemarie Dlc;
van Thiel, Ghislaine Jmw;
Raaijmakers, Jan Am;
van Delden, Johannes Jm;
Bernabe, Rosemarie D L C;
van Thiel, Ghislaine J M W;
Raaijmakers, Jan A M;
van Delden, Johannes J M

Publication type:

journal article

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

Published in:

2012

By:

Bernabe, Rosemarie D L C;
van Thiel, Ghislaine J M W;
Raaijmakers, Jan A M;
van Delden, Johannes J M

Publication type:

journal article

Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study.

Published in:

Developing World Bioethics, 2023, v. 23, n. 1, p. 50, doi. 10.1111/dewb.12348

By:

Seralegne, Yemisrach Zewdie;
Wangamati, Cynthia Khamala;
Bernabe, Rosemarie D. L. C.;
Farsides, Bobbie;
Aseffa, Abraham;
Zewdie, Martha

Publication type:

Article

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

Published in:

British Journal of Clinical Pharmacology, 2014, v. 78, n. 6, p. 1248, doi. 10.1111/bcp.12456

By:

Bernabe, Rosemarie D. L. C.;
Thiel, Ghislaine J. M. W.;
Delden, Johannes

Publication type:

Article

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives.

Published in:

Current Medical Research & Opinion, 2022, v. 38, n. 11, p. 1897, doi. 10.1080/03007995.2022.2115773

By:

Cox, Shereen;
Solbakk, Jan Helge;
Bernabe, Rosemarie D. L. C.

Publication type:

Article

The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents.

Published in:

2021

By:

Cox, Shereen;
Solbakk, Jan Helge;
Bernabe, Rosemarie D. L. C.;
Bernabe, Rosemarie Dlc

Publication type:

journal article

Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?

Published in:

2020

By:

Bernabe, Rosemarie D. L. C.;
van Thiel, Ghislaine J. M. W.;
Breekveldt, Nancy S.;
Gispen, Christine C.;
van Delden, Johannes J. M.

Publication type:

journal article

Extended Reality—New Opportunity for People With Disability? Practical and Ethical Considerations.

Published in:

Journal of Medical Internet Research, 2024, v. 26, p. 1, doi. 10.2196/41670

By:

Stendal, Karen;
Bernabe, Rosemarie D L C

Publication type:

Article

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

Published in:

2016

By:

Bernabe, Rosemarie D. L. C.;
van Thiel, Ghislaine J. M. W.;
van Delden, Johannes J. M.

Publication type:

journal article

Gaps in the ethical governance of pharmaceutical clinical trials in Europe.

Published in:

Frontiers in Medicine, 2025, p. 1, doi. 10.3389/fmed.2024.1507021

By:

Bernabe, Rosemarie D. L. C.;
Dawkins-Cox, Shereen A.;
Gispen-de Wied, Christine C.

Publication type:

Article