Browsing Bergen Open Research Archive by Author "Wendler, David"
Now showing items 1-4 of 4
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Comparative effectiveness research: what to do when experts disagree about risks
Lie, Reidar K.; Chan, Francis KL; Grady, Christine; Ng, Vincent; Wendler, David (Peer reviewed; Journal article, 2017-06-19)Background: Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review ... -
Conducting human challenge studies in LMICs: A survey of researchers and ethics committee members in Thailand
Kaewkungwal, Jaranit; Adams, Pornpimon; Sattabongkot, Jetsumon; Lie, Reidar K; Wendler, David (Peer reviewed; Journal article, 2019)Questions have been raised over the acceptability of conducting human challenge studies in low and middle income countries (LMICs). Most of these concerns are based on theoretical considerations and there exists little ... -
Issues and challenges associated with data-sharing in LMICs: perspectives of researchers in Thailand
Kaewkungwal, Jaranit; Adams, Pornpimon; Sattabongkot, Jetsumon; Lie, Reidar K; Wendler, David (Journal article; Peer reviewed, 2020)Data-sharing helps advance scientific research and assures the benefits of research data are maximized. Previous work has highlighted ethical challenges, especially in low- and middle-income countrie (LMIC) countries. This ... -
Review Mechanisms for Advanced Medical Therapies in Japan and Thailand: A Proposal for the Use of Expert Clinical Benefit Assessments at Designated Institutions
Matsui, Kenji; Israsena, Nipan; Kaewkungwal, Jaranit; Adams, Pornpimon; Wendler, David; Lie, Reidar Krummradt (Journal article; Peer reviewed, 2024)Advanced new therapies, such as stem cell and gene therapies and xenotransplantation, represent challenges for regulatory and ethical review. Major drug agencies, such as in the U.S., India, and Europe, have asserted ...