CP-220 Analysis of the impact of immunotherapy in clinical trials

Background Monoclonal antibody drugs (mAb) are a relative new innovation and have been established as one of the most successful therapeutic strategies in several pathologies. The novel mechanism of action, based on modulation of the immune system, is associated with higher cure rates. Consequently, mAb are considered an attractive therapeutic option and are the subject of study in several clinical trials (CT). Purpose To assess the impact of mAb CT related to total CT managed at the pharmacy department, and different services involved in them. Material and methods Retrospective observational study performed in a tertiary university hospital from January 2014 to September 2015. Data collected: total CT and mAb CT (mAb-CT) by department; mAb-CT/total mAb-CT by department; mAb-CT phase. Reference sources were an internal database, the EU Clinical Trials Register and the American Clinical Trials Database. Results Conclusion More than half of clinical trials from dermatology, rheumatology and cardiology services are evaluating mAb. Considering total mAb-CT, oncology and haematology services are involved in approximately 60% of them. Approval of these mAb is imminent, as more than two-thirds of CT are phase III and will be commercialised soon. Benefit of mAb has been linked to certain pathologies. Consequently, some services with intense research activity have a reduced number of mAb-CT. No conflict of interest.