Experience in managing independent clinical research, the best training strategy for future clinical pharmacists: the QOSMOS project

The path to become a hospital pharmacist in Europe differs from nation to nation. In Italy, attendance at the postgraduate School of Hospital Pharmacy (SHP) is mandatory to work in the National Health System. Recent research published by the National Association of Hospital Pharmacy Students (ReNaSFO) highlighted a lack of education and participation in clinical research among students. Moreover, the internship programme, established by the Italian Ministry of University and Research, requires the participation in at least one multicentre clinical study during the SHP. To fill this gap, in 2017 the Italian Society for Clinical Pharmacy and Therapeutics (SIFaCT) and ReNaSFO established a joint action to improve students’ research competencies. To this end, we designed the QOSMOS study: ‘Quality Of life (QoL) in Multiple Sclerosis (MS): a Multicentre Observational Study’. The study has both educational and scientific objectives. We aim to provide updated results on the QoL of Italian MS patients and look for possible correlations between QoL and diseasemodifying drugs (DMDs). Every participant received, from a panel of expert colleagues, key information on how to design and conduct an observational study, a basic knowledge on QoL measurement and practical support to solve centrespecific issues. Students participated either as coinvestigators or as members of working teams. Investigators enrolled patients, collected clinical data, and administered the QoL questionnaire (MSQoL-54) to patients. Four teams have been established to support participants during submission of the study protocol to ethics committees, to monitor data collection, to perform statistical analysis and, finally, to discuss and publish the results. SIFaCT provided educational material, a scholarship for investigator meetings planned during the Society’s national congresses, and support from an expert pharmacist in each working team. The nationwide organisation of ReNaSFO permitted the rapid enrolment of 22 participants from 16 Italian centres. QoL in MS was chosen as the model disease for several reasons. First, at the time of drug supply clinical pharmacists may deal with QoL issues related to selfadministered DMDs, in which students often do not have a solid background. Second, the frequency of MS permits the participation of students working in both small and large hospitals. Third, this topic stimulated students to become familiar with patientreported outcomes and regression analysis. Participants enrolled 349 patients with MS in 1 year (May 2018 to June 2019). The study achieved primary and secondary endpoints and described possible opposite effects of teriflunomide and dimethyl fumarate on the QoL of MS patients. Results will be published in an original article. From our perspective, one of the most important outcomes of this project is the active participation of so many students. We hope that this practical approach will contribute to an increasing number of multicentre projects conducted by hospital pharmacists in Italy, which is a prerequisite for the promotion of clinical pharmacists in our country. In fact, some students have already used the methodology acquired to develop new independent studies. This organisational model could be considered by other European countries with similar issues, laying the groundwork for possible international multicentre projects.