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The results of a survey involving 1090 adult cancer patients suggesting cancer patients struggle to understand what is involved in a clinical trial were presented at the European Society of Medical Oncology (ESMO) 2017 conference in Madrid last week. In the survey, more than half of the patients did not understand the concept of randomisation or the assumption that all treatments in a clinical trial are treated as equally effective (including the control group) during the design of a randomised controlled trial (RCT) (clinical equipoise), even when they had previously taken part in a clinical trial.
In the survey, 63% of patients thought that “my doctor would make sure that I got the better treatment in a clinical trial,” and 55% said that “my doctor would know which treatment in a clinical trial was better.”
The survey involved 1090 patients who were attending 14 cancer centres in Ireland. About a third (30%) had already taken part in a clinical trial, but more than half of these patients did not understand that randomisation means that the treatment would be allocated by chance. Among the cancer patients who had not participated in a clinical trial, the proportion was even higher ― 73% did not think that the choice of treatment was made on the basis of chance.
“This shows poor understanding of randomisation, and we know this is a difficult concept for patients,” commented lead author Catherine Kelly, MD, associate professor of medical oncology at the Mater Misericordiae University Hospital and University College in Dublin, Ireland. “To provide informed consent when participating in a trial, patients need to understand these key concepts ― and doctors explaining them well is essential to alleviating any fears that might prevent patients from participating. For example, many didn’t realise that clinical trials are not just an option for when standard treatment has failed,” she observed.