EP.40The strategic role of the research nurse: no research nurse, no trial

Abstract

Clinical trials in neuromuscular disorders have dramatically increased in recent years, either the number of different therapies, and the complexity of the trials. The organization for delivering these trials on time to target is paramount important. We present an analysis about the role of the Clinical research unit (CRU), and particularity the study coordinators (SC)/research nurses (RN), as the central pillar of this activity. The number of pediatric trials in our CRU has increased from 104 to 154 in the last two years and, within these, in the area of neuromuscular from 6 to 12. The number of participants in these trials has also increased from 34 to 74 patients. There are many reasons to explain this growth, from one side, the implementation of the EU Pediatric regulation in 2007, but also the organization in a one-stop shop model has definitely contributed to develop our excellence model, which allows us to centrally manage and deliver the different trials of the Institution. The central figure of this model is the SC / SN assigned to each trial, who interacts with all the stakeholders involved in the trial Institution services, Investigator's Team, Sponsor contact and Patients / Families. This coordinating role facilitates the successful implementation of the clinical trials. The organisational model based on trained high skilled RNs allows a flexible allocation of the resources being able to manage more trials, recruit more patients, and deal with the increased complexity due to their experience with different diseases, drugs, vendors... Particularly for neurology disorders, with many orphan diseases, it will allow, in the future, assuming new investigation challenges and we will be able to provide therapeutic alternatives to these patients.