Curating the patient voice

Abstract

Since the 1930’s Contract Research Organisations (CROs) have been employed by pharmaceutical companies to complete their clinical trial-related functions, including the collection of patient experience data (so-called ‘patient voice’ report) to inform the development of new medicines. This practice is legitimated by guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which requires pharmaceutical companies to include patient input in their drug development practices, although they are not permitted to approach individual patients directly - which constitutes marketing. CROs often work with and recruit patients for patient voice reports from Patient Organisations, where patient and caregiver representatives advocate for a wider community with a specific medical condition. However, a Reflections Paper produced by the ICH (2021) acknowledges that the current practice of ‘Patient Voice’ has significant room for improvement. To test the reflections of the ICH, we have analysed a set of patient voice reports that have been conducted by several CROs. These reports are rarely theoretically informed and typically lack methodological detail, and the role of any patient or group of patients in knowledge construction is unclear. We contrast these findings with our own, gathered from sociological research with more marginalised people who have the same condition. We suggest that current pharmaceutical practice obfuscates rather than elevates wider patient perspectives, in a way that continues to put the needs of business, or patients with existing relationships with business, before those of other patients – limiting the potential for the development of personalised medicines.