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Direct linkNabila Khwaja; Manju Varghese; Amal Robay – Journal of Academic Ethics, 2025
ICH-GCP guidelines have provided international ethical, scientific, quality standards for designing, conducting, recording, and reporting of clinical trials, and are hugely popular in the region. Recent revisions to its guidance; ICH-GCP; E6 (R3) have brought significant changes in both structure and content from its predecessor, affecting every…
Descriptors: Guidelines, Ethics, Standards, Clinical Experience
Konstantina Chalkou; Tasnim Hamza; Pascal Benkert; Jens Kuhle; Chiara Zecca; Gabrielle Simoneau; Fabio Pellegrini; Andrea Manca; Matthias Egger; Georgia Salanti – Research Synthesis Methods, 2024
Some patients benefit from a treatment while others may do so less or do not benefit at all. We have previously developed a two-stage network meta-regression prediction model that synthesized randomized trials and evaluates how treatment effects vary across patient characteristics. In this article, we extended this model to combine different…
Descriptors: Medical Research, Outcomes of Treatment, Risk, Randomized Controlled Trials
Gelfand, Scott D. – Research Ethics, 2019
In this essay, I suggest that a slightly modified version of Freedman's formulation of the clinical equipoise requirement is justified. I begin this essay with a brief discussion of the equipoise requirement. In the second and third sections, I discuss several objections to the clinical equipoise requirement as well as two attempts to justify the…
Descriptors: Ethics, Medical Research, Physician Patient Relationship, Parent Child Relationship
