Evidentiary standards and rules of evidence.

2003 ◽  
pp. 17-28
Author(s):  
G. Andrew H. Benjamin ◽  
Jackie K. Gollan
Keyword(s):  
Rules Of Evidence ◽  
Evidentiary Standards

Is there any Indication for Ethics Evidence? An Argument for the Admissibility of some Expert Bioethics Testimony

2005 ◽  
Vol 33 (2) ◽  
pp. 248-263 ◽  
Author(s):  
Lawrence J. Nelson
Keyword(s):  
Expert Witness ◽  
Expert Witnesses ◽  
Proper Place ◽  
Rules Of Evidence ◽  
Evidentiary Standards ◽  
Law Making

Professor Imwinkelried is surely right: the propriety of bioethicists serving as expert witnesses in litigation is problematic, and, I would add, it should remain problematic. Such testimony most certainly does not belong everywhere it will be offered by lawyers and litigants in an effort to advance their interests. Yet in contrast to some commentators, Imwinkelried and I both see a place for bioethicists serving as expert witnesses, although we differ significantly on how to understand and justify this place. In any event, serious questions regarding the proper place for expert bioethicist testimony in the courtroom do exist, not only for law but also bioethics as well.The threshold question regarding the prospect of bioethicists serving as expert witnesses would seemingly have to be: “could a bioethicist qualify as an expert witness under the controlling rules of evidence?” Imwinkelried, however, does not perceive any need to even entertain this question as he claims that “technical evidentiary standards are inapplicable when information is presented to a judge to permit the judge to perform… a legislative or law-making function.”

scholarly journals Enabling patient-reported outcome measures in clinical trials, exemplified by cardiovascular trials

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Theresa M. Coles ◽  
Adrian F. Hernandez ◽  
Bryce B. Reeve ◽  
Karon Cook ◽  
Michael C. Edwards ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Contextual Factors ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Think Tank ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Evidentiary Standards

Abstract Objectives There has been limited success in achieving integration of patient-reported outcomes (PROs) in clinical trials. We describe how stakeholders envision a solution to this challenge. Methods Stakeholders from academia, industry, non-profits, insurers, clinicians, and the Food and Drug Administration convened at a Think Tank meeting funded by the Duke Clinical Research Institute to discuss the challenges of incorporating PROs into clinical trials and how to address those challenges. Using examples from cardiovascular trials, this article describes a potential path forward with a focus on applications in the United States. Results Think Tank members identified one key challenge: a common understanding of the level of evidence that is necessary to support patient-reported outcome measures (PROMs) in trials. Think Tank participants discussed the possibility of creating general evidentiary standards depending upon contextual factors, but such guidelines could not be feasibly developed because many contextual factors are at play. The attendees posited that a more informative approach to PROM evidentiary standards would be to develop validity arguments akin to courtroom briefs, which would emphasize a compelling rationale (interpretation/use argument) to support a PROM within a specific context. Participants envisioned a future in which validity arguments would be publicly available via a repository, which would be indexed by contextual factors, clinical populations, and types of claims. Conclusions A publicly available repository would help stakeholders better understand what a community believes constitutes compelling support for a specific PROM in a trial. Our proposed strategy is expected to facilitate the incorporation of PROMs into cardiovascular clinical trials and trials in general.

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