Clinical Trial Units in Italy: the perception of the Clinical Research Coordinators

Abstract

Background: The complexity of clinical trials (CTs) over the past decade has so gradually grown, that the recent legislation (AIFA Determination 809/2015 for phase I CTs) specifically refers to the need for "connecting figures" involved in Clinical Research (CR). Method(s): In mid 2015 the Clinical Research Coordinators (CRCs) AIOMWorking Group submitted a survey (20 items) to 320 oncology Italian centers, aimed to map the presence of multidisciplinary research teams engaged in the management of CTs, known as Clinical Trials Units (CTUs). All data were collect up to September 2015 and analyzed on October 2015. Result(s): Out of 320 centers,115 (35.9%) completed the survey. 47.1% of the respondents were participating in 20-50 CTs, while 14.7% were involved in more than 50 studies. Moreover, in 63.7% of cases, the center also assumed the duties and responsibilities of sponsoring independent CTs. For these reasons in 71.6% of responding centers declare to have a research team made up of: research nurses (at least one in 67.0%), pharmacists (70.8%), CRCs (94.4%), biologists (61.1%), laboratory technicians (40.0%) and statisticians (56.9%). In 75.5% of the centers that carried out CTs at least one CRC was present: most of them (67.5%) have been working there for at least 6 years and 31% of CRCs have a ten-year-experience in this field. There was a direct association between number of CTs and number of CRCs (p-value 0.0016). CRCs were more frequently employed at Institute Research Centers (IRCCS 72.2% employed 3 or more CRC) while, in public and university hospitals, only 21.4% and 17.2 % respectively hired 3 CRCs or more (p-value 0.0023). About 200 CRCs are active in 77 of the responder centers involved in CR: of these, only 14.9% had an open-ended contract and 10.1% had a fixed term contract; the remaining CRCs were involved, irrespective of seniority, with temporary contracts. 82.4% of the respondents believe that the presence of the CRC is essential for a proper management of the studies and many of them (83.3%) believe that the quality of work is absolutely improved after the introduction of this professional figure in CTU. Conclusion(s):The continuous and increasing complexity of CR and the recent implementation of new regulatory acts, requires the establishment of CTUs and formal institutionalization of this dedicated and specific CR professionals (CRCs) ever more urgent.