Unescheduled visits in cancer patients treated in a clinical trials unit (CTU).

Abstract

e17580 Background: A number of unscheduled visits may occur in addition to the predefined protocol-specific visit calendars in a CTU. The aim of this prospective study was to characterize and assesss the frequency, causes and the probable relationship of the emergencies with the investigational products (IPs). Methods: A consecutive sample of patients treated in a CTU who presented an urgent medical consultation from July 2012 to January 2013 was registered. Epidemiological data, characteristics of emergency visits and relationship with IPs were revised. Results: 141 patients were registered; 75 men (53.2%) and 66 women (46.8%) with a median age of 61.4 years. Most of them had metastatic cancer and 63 patients (44.7%) had been included in phase III clinical trials. Tumors which produced a higher number of events were melanoma (n=53, 37.6%), colorectal (n=24, 17%) and breast cancer (n=21, 14.9%). Those treatments associated with more unscheduled consultations were chemotherapy agents, Braf inhibitors and antiEGFR antibodies. Of those, 45.4% were in-person consultations, whereas the 54.6% were performed by phone. The main causes were pain (18.4%), diarrhea (12.1%), fever (12.1%) and skin symptoms (10.6%). 48.9% were related to an adverse event of the IPs. 78.7% of the consultations were oriented and specifically treated at the moment of the appointment, whereas the 21.3% had to be referred to another service. 36.2% of the unscheduled visits were directly related with the IPs. Of those, 30% were 3-4 graded. Conclusions: Patients treated on a clinical trial generated an elevated number of unescheduled visits and a significant percentage of them are related to the IPs. Most of them should be managed by staff with the appropriate knowledge and training.