CLINICAL TRIAL ACTIVITY IN GREECE FROM 2010 TO 2012- STILL MISSING THE OPPORTUNITIES?
Author(s)
Athanasakis K1, Boubouchairopoulou N1, Alexiou V1, Baroutsou B2, Kyriopoulos J1
1National School of Public Health, Athens, Greece, 2Sanofi - aventis AEBE, Athens, Greece
OBJECTIVES: Clinical trials (CTs) lead to innovative medical treatments, and present positive externalities both for clinical practice and the economy. The study aimed at portraying the CT activity in Greece for 2012, built upon a previous survey conducted in 2010, and at highlighting any discrepancies. METHODS: The survey was conducted among the members of the Hellenic Association of Pharmaceutical Companies (SFEE). Each company was requested to return a structured questionnaire for each interventional CT approved by the National Ethics Committee (NEC) during 2012. Questionnaire items focused on the main characteristics of each CT: duration, phase, budget, number of recruited patients, affiliation of recruiting sites and therapeutic area of the investigational agent. RESULTS: All SFEE members participated returning completed questionnaires (response rate:100%). Data on 70 interventional CTs were received. The majority was phase-III trials (64.3%) as in 2010 (68.3%) with a mean duration of 36.3 months (regardless of phase). Most CT sites were affiliated to a university or NHS hospital (45.7% and 42.3% respectively). A contractionary phase in the CT activity was observed compared to 2010, as demonstrated by the basic characteristics of approved CTs, i.e. average number of patients/trial: 35 vs 98, average number of patient per participating center: 8.68 vs 32.5, average total budget/trial 218,556€ vs 296,598€ for 2012 vs 2010 respectively. CONCLUSIONS: In 2012, the healthcare sector in Greece entered a recession phase due to the severe economic crisis and the subsequent fiscal adjustment program. These measures, accompanied by non-efficient processes in the administrative setting for CT approvals in Greece, appear to have an impact on the country’s CT activity. Given that CTs represent vital investments for the human capital and the economy, joint action from all stakeholders is of paramount importance in order to surpass existing hurdles and to promote investment in research.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PHP174
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Health Care Research
Disease
Multiple Diseases