TOWARDS EVIDENCE-BASED EUROPEAN POLICY IN CLINICAL TRIALS THE SURVEY OF ATTITUDES TOWARDS TRIAL SITES IN EUROPE - THE SAT-EU STUDYTM

Author(s)

Gehring M1;Taylor R*2;Casteels B3;Piazzi A4;Mellody M4;Gensini GF5, Ambrosio G6 1sbg Healthcare Consulting, Pully, Switzerland, 2Peninsula Medical School, Exeter, United Kingdom, 3BC Consulting & Solutions Sàrl, Lausanne, Switzerland, 4Virtuoso Sàrl, Grand Saconnex, Switzerland, 5University of Florence, Florence, Italy, 6University of Perugia, Perugia, Italy

OBJECTIVES: Applications to run clinical trials in Europe have been falling since 2007.  Costs, speed of approvals, and shortcomings of European Clinical Trial Directive (CTD) are commonly held responsible. However, there is no hard evidence on the actual weight of these factors, nor are policy recommendations typically founded on a research-based understanding of factors impacting trial site selection. Indeed, borrowing from the rigour of its own discipline, medical policy decisions ought to be “evidence-based”. METHODS: The SAT-EU StudyTM was an anonymous, cross-sectional Web-based survey designed to systematically assess factors impacting European clinical trial site selection. It explored 19 factors across investigator-, hospital-, and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment. Clinical Research Organizations (CROs), academic Clinical Trial Units (CTUs), and Industry were invited to respond.  OUTCOME MEASURES:  Primary:  Weight assigned to each factor hypothesized to impact trial site selection and trial incidence; Secondary: Desirability of twelve European countries to run clinical trials RESULTS: Responses were obtained from 485 professionals in 34 countries: 49% from BioPharma, 40% from CTUs or CROs. Investigator-, environment-, and hospital-dependent factors were rated highly important, costs being less important (P<0.0001). Within environment-driven criteria, pool of eligible patients, speed of approvals, and presence of disease-management networks were significantly more important than costs or government financial incentives (P<0.0001). Germany, United Kingdom, and the Netherlands were rated the best trial markets (P<0.0001). CONCLUSIONS: Fostering European clinical research does not require additional government spending or a revamping of the clinical trial cost structure. Rather, it requires greater visibility of centres of excellence and the harmonised national adoption of recently approved revisions to the CTD. Carefully crafted harmonization of approvals, including aligned hospital contracting, speedier trial authorization and greater visibility of disease networks may bring significantly more clinical research to Europe and stimulate growth.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP144

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Multiple Diseases

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×