Literature DB >> 27197044

Do We Know Whether Researchers and Reviewers are Estimating Risk and Benefit Accurately?

Spencer Phillips Hey, Jonathan Kimmelman1.   

Abstract

Accurate estimation of risk and benefit is integral to good clinical research planning, ethical review, and study implementation. Some commentators have argued that various actors in clinical research systems are prone to biased or arbitrary risk/benefit estimation. In this commentary, we suggest the evidence supporting such claims is very limited. Most prior work has imputed risk/benefit beliefs based on past behavior or goals, rather than directly measuring them. We describe an approach - forecast analysis - that would enable direct and effective measure of the quality of risk/benefit estimation. We then consider some objections and limitations to the forecasting approach.
© 2016 John Wiley & Sons Ltd.

Keywords:  forecasting; judgment; research ethics; risk/benefit

Mesh:

Year:  2016        PMID: 27197044     DOI: 10.1111/bioe.12260

Source DB:  PubMed          Journal:  Bioethics        ISSN: 0269-9702            Impact factor:   1.898


  3 in total

1.  Details of risk-benefit communication in informed consent documents for phase I/II trials.

Authors:  Hannes Kahrass; Sabine Bossert; Christopher Schürmann; Daniel Strech
Journal:  Clin Trials       Date:  2020-11-24       Impact factor: 2.486

2.  Principal investigators over-optimistically forecast scientific and operational outcomes for clinical trials.

Authors:  Daniel M Benjamin; Spencer P Hey; Amanda MacPherson; Yasmina Hachem; Kara S Smith; Sean X Zhang; Sandy Wong; Samantha Dolter; David R Mandel; Jonathan Kimmelman
Journal:  PLoS One       Date:  2022-02-08       Impact factor: 3.240

3.  Ethics of Early Clinical Trials of Bio-Artificial Organs.

Authors:  Eline M Bunnik; Dide de Jongh; Emma Massey
Journal:  Transpl Int       Date:  2022-07-06       Impact factor: 3.842

  3 in total

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