Patients deserve better information on new drugs

Medicines bring health benefits but may also cause harm. These benefits and harms are often uncertain initially because regulatory approval for new medicines is inevitably based on limited data.1 For example, over two thirds of new cancer medicines, which now comprise the largest category of new treatments, are approved based on single arm trials that have no control groups and only short follow-ups.2 These trials increasingly measure intermediate (surrogate) endpoints that do not reliably predict longer patient survival or improved quality of life.3 Despite these limitations, patients often assume that new treatments are underpinned by high quality evidence.45

To make informed and evidence based decisions about new medicines, patients need to consider the benefits, harms, and uncertainties associated with different treatment options. Patients therefore require access to relevant, useful, and trustworthy information about individual medicines, as well as alternative treatments.6789 However, the medicine information landscape is fragmented and inadequate in meeting patients’ needs.

Conversations between doctors and patients are the main channel for sharing information and making treatment decisions, but patients may forget information provided verbally10 and clinicians may present information in an unbalanced manner.1112 Clinicians often overestimate the benefits of interventions while underestimating harms, partly because of well documented issues in clinical practice guidelines and limitations within peer reviewed literature.121314 Additionally, studies evaluating patient portals and other electronic and written information sources in high income countries show these sources often fall short of providing patients and consumers with accurate, relevant, and easily comprehensible information.1516171819

Well resourced regulatory agencies such as the European Medicines Agency …