An Innovative Medicines Initiative (IMI) and pharmaceutical industry-funded project is led by the European Patients’ Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Consortium members include representatives from patient organisations, regulatory bodies, academia, non-profit organisations, trade associations, and pharmaceutical companies, along with subject matter experts.

The project will span 30 months and build on the output from previous initiatives, closing gaps and providing a suite of tools focused on patient engagement at three key points in the medicines lifecycle: research priority setting, design of clinical trials, and early dialogue with regulators and Health Technology Assessment (HTA) bodies.

In order to accomplish this goal, PARADIGM needs to articulate consensus-forged strategies and processes that are sustainable beyond the end of the project, leaving a legacy of both culture and process change. Central to this is the construction of success factors, namely performance metrics, of both activity and outcome. These must take into account the broad affiliations of stakeholders and the intersectionality of success measures within this arena. Ironically, this is the largest challenge, as the differing stakeholders view the value of patient engagement from different reference points.

A core tenet of patient engagement advocates is the belief that embedding patients’ perspectives in medicine development will provide a competitive advantage as it ultimately will better address the needs of the community. Medicines that meet patients’ needs are more likely to be valued and thus reimbursed and made widely available. There are also strongly-held beliefs that patient engagement is simply an inherent good; the cost of not engaging patients is a price too high to pay and one which should not continue to be shouldered by society. The economic benefits associated with engagement in terms of time and quality components have been effectively modeled. Yet, monetisation alone of what is viewed as a social good diminishes the intrinsic and long-term value of the engagement.

Continuing to merely engage in circular counterpoint arguments comes with a strong cautionary note. The time has arrived for varied perspectives to converge in order to properly guide the co-creation of performance metrics and thrust these forward in partnership. Irrespective of the chosen measure, more standardised methods of data collection and reporting are also required.

PARADIGM is well-positioned to advance this and has the mandate to do so. Ultimately, the imperative exists to move from the anecdotal to a broadly accepted, evidence-based model of assessment that considers the multifaceted nature of patient engagement. The overall goal is to provide a framework that allows structured, meaningful, sustainable, and ethical patient engagement. If PARADIGM is to live up to its name, it needs to deliver a scaffolding that can bring about the change needed to transform patient engagement within the medicines lifecycle.

Patient advocacy groups and industry have, both individually and in partnership, formed initiatives to define and draft frameworks that give shape to what has previously been a largely ad hoc process. A shared desire exists to embed patient engagement as standard practice within the medicines lifecycle.

Patients Active in Research and Dialogues for an Improved Generation of Medicines (or PARADIGM) was funded by the Innovative Medicines Initiative and arises as a new initiative, adding itself to the growing ranks of patient engagement partnerships. It is a novel collaboration that draws strength from the breadth of its 34 public and private partners and its commitment to including the voices of young, cognitively impaired, and unaffiliated patients.

An Innovative Medicines Initiative (IMI) and pharmaceutical industry-funded project is led by the European Patients’ Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Consortium members include representatives from patient organisations, regulatory bodies, academia, non-profit organisations, trade associations, and pharmaceutical companies, along with subject matter experts.

The project will span 30 months and build on the output from previous initiatives, closing gaps and providing a suite of tools focused on patient engagement at three key points in the medicines lifecycle: research priority setting, design of clinical trials, and early dialogue with regulators and Health Technology Assessment (HTA) bodies.

In order to accomplish this goal, PARADIGM needs to articulate consensus-forged strategies and processes that are sustainable beyond the end of the project, leaving a legacy of both culture and process change. Central to this is the construction of success factors, namely performance metrics, of both activity and outcome. These must take into account the broad affiliations of stakeholders and the intersectionality of success measures within this arena. Ironically, this is the largest challenge, as the differing stakeholders view the value of patient engagement from different reference points.

A core tenet of patient engagement advocates is the belief that embedding patients’ perspectives in medicine development will provide a competitive advantage as it ultimately will better address the needs of the community. Medicines that meet patients’ needs are more likely to be valued and thus reimbursed and made widely available. There are also strongly-held beliefs that patient engagement is simply an inherent good; the cost of not engaging patients is a price too high to pay and one which should not continue to be shouldered by society. The economic benefits associated with engagement in terms of time and quality components have been effectively modeled. Yet, monetisation alone of what is viewed as a social good diminishes the intrinsic and long-term value of the engagement.

Continuing to merely engage in circular counterpoint arguments comes with a strong cautionary note. The time has arrived for varied perspectives to converge in order to properly guide the co-creation of performance metrics and thrust these forward in partnership. Irrespective of the chosen measure, more standardised methods of data collection and reporting are also required.

PARADIGM is well-positioned to advance this and has the mandate to do so. Ultimately, the imperative exists to move from the anecdotal to a broadly accepted, evidence-based model of assessment that considers the multifaceted nature of patient engagement. The overall goal is to provide a framework that allows structured, meaningful, sustainable, and ethical patient engagement. If PARADIGM is to live up to its name, it needs to deliver a scaffolding that can bring about the change needed to transform patient engagement within the medicines lifecycle.