Excerpts from a Pharmaphorum article:
There are several examples of research illustrating that patient engagement at different points of the medicines lifecycle is critical to fostering patient access to innovative therapeutic solutions and delivering better health outcomes for patients.
Despite this, patients continue to be a largely underutilised resource in medicines development. For key stakeholders, such as researchers/drug developers, regulatory authorities, HTA bodies (reimbursement agencies), and patient organisations, pertinent and basic issues across all groups are: who should be involved, how and when.
Patient engagement is continually gaining momentum, but its evolution so far has been ad hoc and piecemeal. While there are many initiatives emerging to involve and engage with patients, inconsistency and fragmentation remain the norm. As attempts are made to advance patient engagement across the entire spectrum of healthcare, it is evident we have now reached a tipping point. Concerted efforts to communicate and collaborate with all stakeholders in healthcare in order to achieve best practice within this expanding area are now critical.
This is where PARADIGM comes in – Patients Active in Research and Dialogues for an Improved Generation of Medicines. A European-centric public-private partnership co-funded by the Innovative Medicines Initiative and members of the pharmaceutical industry, the 30-month project is led by the European Patients’ Forum (EPF) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
PARADIGM is truly unique – a highly innovative, consensus-oriented, and experienced consortium of 34 members, comprising leaders in patient engagement, academia, health professionals, pharmaceutical and biotech companies, patient groups and regulatory bodies, among others.
The ultimate goal is to achieve maximum synergies in this crucially important area. This will be achieved by working closely with other initiatives focusing on the patient’s voice in the life cycle of medicines, such as Patient Focussed Medicines Development (PFMD) or the European Patient Academy on Therapeutic Innovation (EUPATI).
A core objective is to develop an inventive and workable sustainability roadmap to optimise patient engagement at distinct points across medicines’ R&D.
This will involve developing much-needed processes and tools for three key decision-making points within the medicines life cycle, namely:
- Research priority setting
- Design of clinical trials
- Early dialogue with regulators and health technology assessment (HTA) bodies.
The project will also aim to provide a unique framework that enables meaningful patient engagement, while demonstrating a ‘return on engagement’ for all players.
PARADIGM will integrate the needs, perspectives and expectations of all actors, and is committed to including the voice of the young, cognitively impaired, and unaffiliated patients. We wish to strengthen the understanding of stakeholders’ needs and expectations for engagement, including these underrepresented and vulnerable populations.
Uniquely, the project will also produce an agreed set of metrics to measure the impact of patient engagement practice, while increasing the evidence demonstrating the impact of these practices.
PARADIGM is committed to listening to, and learning from patients, in order to advance meaningful patient engagement. This will be combined with the perspectives of other relevant stakeholders represented in the medicines lifecycle. Expectations are high – assessing these expectations in order to find alignment is a key focus of our initial work.
The first steps will ultimately lead to the development of a framework that will enable meaningful, impactful, ethical and sustainable patient engagement, via a set of comprehensive tools and practices in order to support mainstreaming the integration of patient perspectives and experiences while enhancing mutual trust among the different stakeholders in the patient engagement process. The path to meaningful patient engagement is being paved.
Read the full article here: https://pharmaphorum.com/views-and-analysis/time-optimise-patient-engagement/