1. Clinical trial activity in Greece: opportunities missed, soon to be forgone (?) Kostas Athanasakis 1, Marios Detsis 1, Barbara Baroutsou 2, John Kyriopoulos 1 Department of Health Economics, National School of Public Health, Athens, Greece Hellenic Association of Pharmaceutical Companies (SFEE), Athens, Greece Objective / Aims 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 one questionnaire per interventional CT approved by the National Ethics Committee during 2010. The questionnaire focused on a number of key characteristics of each trial, such as the phase of the trial, its duration, the number of patients and recruiting sites, the therapeutic area of the agent under survey and the study budget. Results Fifty of the 65 SFEE members (77%) responded. Overall, the companies that participated in the survey had, in total, 79 interventional trials approved during 2010. The basic characteristics of those trials were as follows: -phase of trial The majority of CTs was phase-III (N= 54, 68.3% of total). Of the remaining 25, 2 were phase-I (2.5%), 11 (14%) were phase-II and 12 (15.2%) were phase-IV trials. -therapeutic area The approved studies focused mainly on oncology (26.5%), endocrine disorders (16.4%), cardiovascular diseases (13.9%), diseases of the blood (10.3%), respiratory diseases (6.3%) and musculoskeletal disorders (6.3%). -duration Mean duration per trial was 36.9 months (s.d.: 27.7) and varied depending on the phase. Phase-III trials, had a mean of 37.9 months (26.7), whereas phase-II and -IV a mean of 43.8 (38.3) and 20.5 (10.4) months, respectively. -number and affiliation of recruiting sites On average 4.75 recruiting sites participate in each study (s.d.: 2.8). Sites are mainly affiliated with a university (teaching) hospital (46%) or a NHS hospital (46%). Each site recruits 6.3 patients on average, (s.d.: 3.3). The highest mean numbers of recruited patients per CT, according to the therapeutic area of the agent under investigation, were reported for circulatory diseases (53.2 patients per trial), respiratory diseases (52.2), central nervous system disorders (37.5) and endocrine disorders (25.8 patients). -budget The average budget per CT was 296,602€ (s.d. 389,948€). Phase-II trials had the highest budget (367,563.6€, s.d.: 688,885€), followed by phase-III (306,567.5€, s.d.: 365,845.5€) and phase-IV (234,515.5€ s.d.: 252,811.6€). Conclusions  According to published data, the number of pivotal CTs conducted in Greece is extremely low, compared to its European peers and stagnant over the past 3 years. Within a global market context, this constitutes a problem of lost research opportunities and underuse of the country’s acknowledged scientific capacity.  Major hurdles are “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. ISPOR 14th Annual European Congress 5-8 November 2011, Madrid, Spain Acknowledgments: the present study was financially supported by SFEE (Hellenic Association of Pharmaceutical Companies)