A nurse-based organizational model to conduct clinical trials in respiratory diseases: experience from Palma de Mallorca

Introduction: Clinical trials (CT) are the cornerstone of evidence-based decision making in clinical and translational pulmonary research. There is currently lack of standardized guidelines, which regulate the infrastructure and CT activities. Our objective was to develop a novel organizational model which leads to more cost-effective and efficient CT management. Methods: In 2013, the Balearic Health Research Institute founded a Clinical Trial Unit (CTU) to support the research. We analyzed the activity related to respiratory CTs during 2016 and 2017. Results: The CTU consisted of: 1) two full-time qualified nurses specialized in CTs 2) two part-time pulmonary physicians with administrative support. Two outpatient offices were equipped with spirometers, electrocardiograph, questionnaire reader and equipment to process biological samples including blood and sputum. During 2016-2017, 12 CTs (5 with biologic drugs and 4 with oral/inhaled therapy) and 3 observational studies were performed. A total of 359 medical exams, 207 blood tests and processing, 116 complete function evaluations, 68 six-minute-walking tests, 187 post-bronchodilator spirometries, 94 exhaled nitric oxide (eNO), 232 electrocardiograms, 29 induced sputum analysis and 203 questionnaires were performed. All the results obtained were entered in an electronic Case Report Form. Conclusions: We report an organizational model for the development of CTs, based on a CTU available for all the affiliated hospitals. In the CTU, the nursing staff plays a central role, which allows a more effective employment of human resources by distributing the work load equally across the health care providers and the nursing staff.