Just as the pace of medical innovation has sped up dramatically in recent years, so has the development of patient engagement in the medicine development process.
A recent article published in the DIA Global Forum, Patient Engagement That Enables Regulatory Decisions: Co-Creating Next Steps in Patient-Focused Drug Development, reports a ‘step change’ in momentum as we move from talking about patient centricity to new models of partnership which recognize patients as formal stakeholders and equal partners in drug development.
Arguably the most challenging aspect for medicine developers is the need to meet the growing expectation from regulators for robust patient experience data (PED) that demonstrate the impact new products may have for patients and their quality of life. To meet this challenge, our industry will need to work closely with the patient community, regulators, and other stakeholders to develop robust methodology for data collection and analysis, as well as having systems and processes in place to put that into practice.
There has already been significant progress on this transformational journey, with many resources available or in development to support companies. The FDA is creating a series of Patient Focused Drug Development (PFDD) guidance documents, the EMA has committed to publishing a reflection paper to consider how best to generate and collect PED, while the MHRA also plans to develop guidance outlining how to include patients meaningfully into the design and conduct of trials. A repository of resources is also being co-created by a global multi-stakeholder group including Patient Focused Medicines Development (PFMD), which will be presented at DIA Europe 2023.
This positive progress, and clear acknowledgement of the value of PED by regulators, is a significant step forward. There is also recognition of the need to support the patient community with appropriate training and resources to enable patient involvement.
What will be key for the industry is putting systems and processes in place for early patient engagement in medicine development across the whole medicine development pathway. This will in turn enable the planning needed for generating and collecting PED, and future-proof clinical trials and commercialization strategies. Demonstrating the value of patient engagement will also be critical, with clear KPIs and measurement and feedback mechanisms for all activity, which is where tools such as the PFMD (Patient Focused Medicine Development) Patient Engagement Framework can provide useful guidance.
Our goal at Lumanity is for patients to be recognized as formal stakeholders and partners in medicine development and to help clients embed the patient voice and patient engagement across strategic and tactical planning, co-creation, and delivery.
To find out more about how we can help, contact Susan Daniels, VP Patient Strategy and Engagement or Sarah Davies, Patient Engagement Director.
