Patients’ perspective is important in all medical research, and particularly in drug development. This month, a public-private research initiative called PREFER has been launched to assess how patient views on risks and benefits should be incorporated when making decisions about medicines.

Patients are the people who consume medicines, and therefore need to be involved during drug development. Their voice is becoming increasingly important, not only for the companies that develop new therapies, but also for the regulatory authorities. These authorities assess, regulate and decide which drugs are effective, well tolerated and cost-effective.


Industry, regulatory authorities, health technology assessment bodies, reimbursement agencies and patient organisations are in agreement regarding the high value of patient preferences. However, there is little guidance on conducting and using such studies in pharmaceutical industry, regulatory and reimbursement decision environments. PREFER will provide a set of systematic methodologies and recommendations to assess, engage and include patient perspectives during the development, approval, and post-approval of new therapies. 

PREFER is a five-year project funded by the Innovative Medicines Initiative (IMI) to evaluate different ways of assessing clinical patient preferences. The project will establish recommendations to support development of guidelines for industry, Regulatory Authorities and HTA bodies on how and when to include patient perspectives on benefits and risks of medicinal products.


“Almost all decisions taken in research, trials and approval somehow affect patients, which is why we involve patients directly as partners in the PREFER project. We have also created patient advisory groups to make sure the project gets input from a wider patient community.” Prof. Mats G. Hansson, Uppsala University’s Centre for Research Ethics & Bioethics (CRB) stated.


The European Cancer Patient Coalition (ECPC) is one of the four patient organisations in the Patient Advisory Group of the project. The role of ECPC is to lead the Patient Advisory Group and to ensure that the methodologies identified are consistent with the specific views, experiences and preferences of patients.

 “By working together with the other stakeholders we will work towards ensuring that patient preferences are converted into practical applications that improve health outcomes” says Prof. Francesco De Lorenzo, ECPC President.


PREFER will run patient preference studies in three disease areas where patient and clinical research partners of the project have expertise in: cancer, rheumatoid arthritis and neuromuscular disorders.


“We have put a lot of effort into building close collaborations between academic and industry researchers, health and technology assessment bodies, payers, regulators and patients to investigate how patient preference studies can best address everybody’s needs. We believe that PREFER will provide recommendations that can support the development of guidelines for industry, regulatory authorities and HTA bodies for all medicinal products” says Conny Berlin, Novartis.


* This project has received funding from the Innovative Medicines Initiative 2 Joint undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the EFPIA. *