Periodic Reporting for period 4 - PREFER (Patient Preferences in benefit risk assessments during the drug life cycle - Sofia ref.: 115966)
Reporting period: 2019-10-01 to 2020-09-30
Based on discussions with the Scientific Advisory Group and the different stake holder groups associated with PREFER (Regulators, HTA, Patients) a focused strategy identifying a selected number of methods and research questions that may lead to effective recommendations has been adopted. The second phase of PREFER aimed at evaluating preference methods and research questions in clinical context where there is a preference sensitive decision to be made, i.e. one where information about patient preferences may provide an added value to regulators, HTA and industry when making their decisions. Three core clinical case studies are underway and have provided results and will provide their final reports shortly. Data have been gathered on the use of Discrete Choice Experiments (DCE), Best-Worst Scaling, Threshold techniques, and Swing-Weighting with comparisons of a number of other methods for the elicitation of patient preferences. Three additional industry led case studies have already presented interesting results both from explorative studies and quantitative based methods. Five additional case studies were selected after the same thorough review process from academic partners. Three case studies have delivered their final reports, seven are finalising their reports before end of March 2021. One study on eye-tracking will eventually not be carried through due to the COVID-19 situation that has prevented meetings both with patients and health care professionals. These clinical case studies are responding to a great number of the PREFER methodological research questions identified in the first phase of the project and preparations are already in place for integrating the results in the final recommendations and in the ongoing Qualification process that PREFER has initiated jointly with EMA and EUnetHTA.
While PREFER is focussed on scientific questions, operational aspects are equally important for the credibility of patient preference studies. To that end, PREFER is well underway of developing an operational best practice document that will be informed by stakeholder needs and learnings from case studies. Some topics might be more effectively addressed by other projects and may even not be in scope of PREFER in a strict sense. Therefore, PREFER has found opportunities to collaborate and to create synergies with other initiatives. PREFER has organized a joint workshop with patient organizations IMI PARADIGM focusing on how best to involve patients in medical decision making and joint meetings are held. The results from this workshop I currently being integrated within the final recommendations from the PREFER project.