A new collaboration involving 34 public and private partners has been formed in an effort to enable patients to be engaged in drug development and approval processes.
Paradigm– Patients active in research and dialogues for an improved generation of medicines – comprises a mix of partners from patient organisations, regulators, universities, not-for-profit organisations, small and medium sized enterprises (SMEs), trade associations and pharmaceutical companies.
The consortium is funded from the EU’s Innovative Medicines Initiative and led by the European Patients’ Forum and the European Federation of Pharmaceutical Industries and Associations.
Paradigm said patient engagement in biomedical research is key to better health outcomes. The consortium said it will “build on existing tools, fill knowledge gaps, define how to make all tools available to those who need them, raise awareness amongst those who think they do not need them, and build a sustainable roadmap for patient engagement”.
At the end of the 30 months of the project, the consortium said patients and researchers will have access to “a framework that allows structured, meaningful, sustainable and ethical patient engagement throughout three key decision-making points of the development of drugs: the research priority setting; the design of clinical trials and the early dialogues with regulators and HTA [health technology assessment] bodies”.
Paradigm will work with other patient engagement initiatives, organising the first Open Forum on Patient Engagement jointly with Eupati, the European Patients’ Academy on Therapeutic Innovation and PFMD, Patient Focused Medicines Development.
Mathieu Boudes, Paradigm project coordinator, said: “The first Open Forum on Patient Engagement is a stepping stone toward synergies and alignment between the project partners and extended patient engagement community.
“In the coming months, Paradigm will invite researchers, patients, regulators, HTA bodies and all other biomedical research players to join the extended project community and engage to provide different perspectives and input,”he said.