Advancing Patient and Public Involvement (PPI): The Strategic Role of Pharmaceutical Medicine

The Working in Partnership with Patients & Communities Forum FPM recently published a letter [1] in response to the publication of a study on the reporting of patient and public involvement (PPI) in research publications [2]. It was pointed out that while the practice of PPI itself involves stakeholders such as academia, funders, industry, regulators, and publishers; the consistent, standardised reporting of PPI lies primarily in the remit of journals and their editorial policies. The British Medical Journal (BMJ) has been a leader in this field with a dedicated PPI subsection within the methods section of its articles. Our letter called upon regulators, trial registries, industry sponsors, academic institutions, and grant-giving bodies to mandate PPI in research design, conduct, dissemination and publication.

PPI in healthcare is a multistakeholder endeavour. Groups from academia, charities, publishers, and regulators have made important progress in embedding patient and public voices into decision-making [3-8]. Although PPI has gained momentum over the past decade, it is still neither consistently practiced nor fully embedded as a standard in health research and development (R&D). Mandates from organisations like Consolidated Standards of Reporting Trials (CONSORT), Health Research Authority (HRA), Food and Drug Administration (FDA), etc are designed to encourage PPI in the conduct of Clinical Trials. However, guidance such as Guidance for Reporting Involvement of Patients and the Public (GRIPP 2), the International Council for Harmonisation’s guideline for Good Clinical Practice (ICH GCP) E6, isn’t always followed. In the absence of formal mandates and lack of universal adoption of guidance, to create a standard of practice for PPI, the life science industry and specifically pharmaceutical medicine cannot just participate; it must lead. The life science industry, unlike other stakeholders, is uniquely positioned for PPI not only in randomised controlled trials (RCT’s) but in the development lifecycle of drugs and devices (R&D, approval, and post-marketing). It also has a global infrastructure to scale good practice across geographies and therapeutic areas.

Pharmaceutical medicine can lead by:

1. Ensuring PPI in R&D strategy and operations is as an integral part from the earliest stages of discovery and not an add-on.
2. Recognising that true PPI requires time, training, fair compensation, and resources for an effective partnership.
3. Investing in digital and data tools that make patient and public input easier to collect, analyse, and apply at scale.
4. Publishing reports on how patient and public input has impacted recruitment and retention in clinical trials, conduct of trials, treatment adherence, and a change in overall healthcare outcomes [9,10].

Our blog is a call for further research and publication in this field to create an evidence base, for example, the evidence generated by studies within a trial (SWATs) [10-14]. We believe that the life science industry, and specifically the discipline of pharmaceutical medicine, can and should lead with the practice of PPI. With its global reach, resources, and central role in the healthcare ecosystem, it is uniquely placed to transform PPI from being the exception to becoming the norm.

Competing interests: None declared.