11 April 2023

Leaflets do not always reflect uncertainty about research, study finds

Information given to patients about the benefits and potential risks of cancer drugs is often inadequate and potentially misleading, according to a new study published in British Medical Journal.

The researchers from King’s College London, Harvard Medical School and the University of Sydney found that cancer drug information leaflets for patients in Europe often omit important facts.

They reviewed official written and electronic information for clinicians, patient information leaflets and public summaries of 29 new cancer drugs approved by the European Medicines Agency between 2017 and 2019. Then they compared the information on drug benefits with data available in the drugs’ regulatory assessment documents.

The researchers found many instances where the leaflet and summary information was “potentially misleading” when compared with the regulatory documents. Important gaps and uncertainties about the evidence for extended survival or improved quality of life were rarely reported. And scientific concerns about the reliability of evidence about medicine benefits were rarely communicated.

“Regulated information sources for anticancer drugs in Europe fail to address the information needs of patients,” the authors wrote. “If patients lack access to such information, clinical decisions may not align with their preferences and needs.”