Are underpowered clinical trials ethical?
All clinical trials entail some level of risk for participants. Statistically underpowered clinical trials are not able to produce valid scientific knowledge, which makes them unethical. A recent article in the Journal of the Royal Society of Medicine points to the important role that ethical review committees can play in examining the sample size calculations.
Stefan Eriksson, co-author of the article.
Small underpowered clinical trials were common 20 years ago. During the COVID-19 pandemic, we saw a remarkable surge, where some trials included fewer than 50 participants.
According to Stefan Eriksson, Director at the Centre for Research Ethics & Bioethics (CRB) at Uppsala University and one of the authors, ethical review committees must ensure trials are scientifically and socially valuable by scrutinizing sample size calculations. Together with co-authors, he puts emphasis on the fact that trials with insufficient participants can only be considered ethical if researchers already plan to pool data with similar studies, and provide clear information to participants about this strategy. Failing to disclose these limitations undermines informed consent and participants' trust.
According to the authors, ethical review committees should protect participants and uphold scientific integrity by rejecting underpowered trials, unless data-sharing agreements are in place before approval. Clear communication and careful ethical review are essential to ensure that clinical trials provide meaningful contributions to medical knowledge, even during global health emergencies.
Do you want to know more? Read the article: Dal-Ré R, Eriksson S, Latham SR. Underpowered trials at trial start and informed consent: action is needed beyond the COVID-19 pandemic. Journal of the Royal Society of Medicine. 2024;0(0). DOI: 10.1177/01410768241290075.
By Fanny Klingvall