Clinicians, sponsors, ethics review committees, and others are charged with ensuring that risk is in a favourable balance with benefit when patients enrol in trials. Yet how do they make this judgment, when the only evidence available is from preclinical animal studies? In our recent article published in the Journal of Medical Ethics1, we offer… Continue reading Balancing the Evidence: Animal efficacy studies should have more weight in the risk/benefit calculus ahead of clinical trials
Author: Valerie Henderson
Too much of a good thing
A novel anti-cancer drug is found to shrink every tumour type tested in experimental animal models. Let’s rejoice and start clinical trials without delay! Well, not so fast. Preclinical experiments in animal models are aimed at showing that a new drug will be useful in human beings. However, individual animal experiments are often too small… Continue reading Too much of a good thing
Uncaging Validity in Preclinical Research
High attrition rates in drug development bedevil drug developers, ethicists, health care professionals, and patients alike. Â Increasingly, many commentators are suggesting the attrition problem partly relates to prevalent methodological flaws in the conduct and reporting of preclinical studies. Preclinical efficacy studies involve administering a putative drug to animals (usually mice or rats) that model the… Continue reading Uncaging Validity in Preclinical Research