• 26Jul

    Patients’ roles and rights in research

    Excerpts from the editorial piece in the BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3193

    Full partnership with patients is essential to any modern research enterprise

    Patient and public involvement in research is becoming a mainstream activity thanks to recognition by everyone in the research process from funders and regulators to conference organisers and publishers that it helps them do a better job. There is certainly a strong case for increasing the value to patients and the public from the billions spent on biomedical research. The exponential rise in research output has seen a decline in quality1 and mounting concern about high levels of waste, bias, inefficiency, and error.2 A collaborative effort is needed to reform the research enterprise, and patients and the public have a leading part to play.3

    Including patients and the public as partners in research is accepted best practice in several Western countries, and some funders make it mandatory. The BMJ supports this by requiring authors to report the extent of patient and public involvement in all submitted research.4 It is clear, however, that some researchers struggle to differentiate between qualitative research (when patients’ experiences are sought and used as data) and including patients as true research partners (when their views and experience contribute to decisions about the research agenda and the design, conduct, and reporting of studies).5

    One of the main stumbling blocks to “coproduction” of research with patients and the public is that professionals lack knowledge, skills, and experience on how best to do it. Although guidance is available from organisations like NIHR and the Patient-Centered Outcomes Research Institute (PCORI),1718 adapting this to specific situations can be challenging. An enthusiastic and committed lead researcher is often needed to see such work through. Some organisations and research networks are making progress,18 but their work needs to be more widely replicated and disseminated internationally.18

    One particular challenge is to ensure diversity within collaborations so the interests of the well-educated white middle classes in rich countries do not dominate.19 Patient leaders must be supported and empowered to engage diverse communities from the outset. The Food and Drug Administration’s patient focused drug development programme, for example, started by running in-person meetings around Washington DC but now provides standards for advocacy organisations to contribute virtually. Non-profit organisations such as the Amyotrophic Lateral Sclerosis Association have surveyed patients online, giving voice to those unable to attend meetings.20

    Giving real power to patients and those who care for them will entail shaking up existing research hierarchies, not merely smoothing out a few bumps in current practice. Senior researchers should lead by example and embrace this essential culture change. Coproduction of research must go beyond a handful of enlightened practitioners responding only to the most vocal (and well funded) patient communities, to become the new global norm for clinical research.

    To advance this move, the BMJ is extending its current requirement to report how patients and the public were included in the design, conduct, and reporting of clinical research studies across its portfolio of journals.21 In addition, from January 2019 onwards we will require authors of clinical research papers to provide details of how they intend to disseminate results to participants and relevant communities. We have also pledged to work with others to define and enshrine best methods for coproduction of research.

    This is a critical point in the development of patient and public involvement: appraisal of the fundamental rights—or lack of them—that underpin patient, carer, and public inclusion in research as both participants and coproducers is timely. Later this year, we will host a meeting to examine the issues raised in this editorial and set the agenda for further debate. We invite comment and thought on the current state and future path of patients’ rights and roles in research.

    Read the full article here: https://www.bmj.com/content/362/bmj.k3193