CLINICAL TRIAL ACTIVITY IN GREECE- OPPORTUNITIES MISSED, SOON TO BE FORGONE (?)
Author(s)
Athanasakis K1, Detsis M1, Baroutsou B2, Pavi E1, Kyriopoulos J11National School of Public Health, Athens, Greece, 2Sanofi-Aventis Greece, Kallithea , Attica, Greece
Presentation Documents
OBJECTIVES: Clinical trials (CTs) represent important investments in the clinico-economic setting, as well as in the “human capital” of developed economies. The purpose of the study was to depict CT activity in Greece for 2010. METHODS: A questionnaire-based survey was conducted among the members of the Hellenic Association of Pharmaceutical Companies (SFEE). Each company was requested to return via email one questionnaire per interventional CT approved by the Hellenic National Ethics Committee in the year 2010. Items in the questionnaire focused on the following points: phase of the trial, duration, number of patients, CT sites, therapeutic area of the agent under survey and planned budget for the study. The survey lasted for 4 months (December 2010-March 2011). RESULTS: Fifty of the 65 SFEE members returned questionnaires (response rate 77%). The majority of CTs was phase-III trials (67%), mainly on oncology (26.5%), endocrine disorders (16.4%) and cardiovascular diseases (13.9%). Most CT sites were affiliated with a university (46%) or an NHS hospital (46%), enrolling 4.5-7.5 patients, on average, depending on CT phase. The average budget per CT was 296,600€ (s.d.: 389,948€). In total, 120 interventional CTs were approved in 2010 in Greece, with the total investment estimated at 35.6 million Euros. CONCLUSIONS: Compared to its European peers, the number of CTs conducted in Greece is extremely low. Within a global market context, this constitutes a problem of lost research opportunities and underuse of the country’s acknowledged scientific capacity. Major hurdles could be identified in the “bureaucracy” and complexity of the approval process, mainly within NHS, lack of acknowledgement of CT as key priority for research investment and lack of a strong framework for health technology assessment. Quick changes are necessary, in order to cover the distance lost.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PHP107
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Health Care Research
Disease
Multiple Diseases