A recent article published in Nature Reviews Drug Discovery caught the eye of our Patient Centred Outcome research team this month. The article (Calvert et al. 20191) outlines the current challenges and strategic priorities for collecting patient reported data in real world studies.
The authors begin by acknowledging the lack of patient reported data in many published real world studies and comment on the recent increased emphasis on patient-centric drug development and the important role of patient reported data (including quality of life, symptoms and physical functioning).
They then summarise the current challenges in the collection of patient reported data in the real world. The biggest challenge is the lack of routine use of patient reported outcome (PRO) measures in clinical practice, which means that patient reported data is often not available in clinical notes. At OPEN VIE we find this is a common problem and have identified key medical specialities that are more likely to have routinely collected PRO data available in clinical notes, for example dermatology. For those situations where this data is not available, we will usually design a bespoke patient reported study for our clients to address this data gap.
The authors propose several key strategic priorities to optimise the collection of patient reported data in the real world. These include collaboration amongst multiple stakeholders to agree to a standardised PRO assessment in clinical practice, alongside developing a standard set of research tools for the collection of patient reported data in the real world. The use of electronic PROs is promoted, which can reduce patient burden and improve ease of questionnaire completion. Importantly, the authors also comment on the need to ensure that patients and clinicians have access to the data from patient reported studies to tailor care to individual needs.
This interesting article provides a thought-provoking summary of the challenges and key priorities for collection of patient reported data in the real world. It highlights the need for common guidance on the process for generating patient reported evidence and presents the barriers to the routine use of PRO measures in clinical practice.
Our specialist Patient Centred Outcome research team are experts in the collection of data from patients and carers. Our key area of interest is in real world data collection, where we work alongside our Real World Evidence colleagues to design and execute bespoke studies that explore and measure the impact of a disease or treatment from the patient perspective to enhance and differentiate your evidence package.
1J. Calvert, Melanie & J. O’Connor, Daniel & M. Basch, Ethan. (2019). Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes. Nature Reviews Drug Discovery. 10.1038/d41573-019-00088-7.