LANDSCAPE ASSESSMENT OF PROSPECTIVE REAL-WORLD EVIDENCE STUDIES IN EUROPE
Author(s)
König C1, Krinke K1, Haas JS1, McLeod K2, Braun S1
1Xcenda GmbH, Hannover, Germany, 2Xcenda LLC, Palm Harbor, FL, USA
Presentation Documents
OBJECTIVES: Prospective studies are mainly designed to collect data for future events in support of a specific research question. These studies are subdivided into clinical trials as well as observational (real-world evidence) studies. The main aim of this analysis was to identify prospective observational studies and the percentage on the overall conducted prospective studies in different European countries. Furthermore, this analysis aimed at stratifying the identified studies by indication. METHODS: A ClinicalTrials.gov database search was performed by applying the categories country, study type, indication, and excluding retrospective studies. In a next step, the search was limited to observational studies including all recruitment conditions. Studies of the last ten years (06/01/2008 until 05/31/2018) in the following European countries Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, and United Kingdom (UK) were included. The top five indications in the respective country were investigated. Moreover, the influence of the population and pharmaceutical market size as well as different regulatory requirements in each country were considered in the interpretation of results. RESULTS: The overall number of registered prospective observational studies varied between the countries with France (n=3,232), Germany (n=2,290), UK (n=1,763), Italy (n=1,349), Spain (n=1,036), Netherlands (n=986), Denmark (n=971), Belgium (n=846), Sweden (n=514), Norway (n=447), Finland (n=240), and Luxembourg (n=33). The proportion of observational studies in relation to the number of overall prospective studies ranged from 13.0% (Spain) vs. 41.3% (Luxembourg). Furthermore, vascular and heart diseases as well as respiratory tract diseases were among the top five indications in most of the countries. CONCLUSIONS: Large differences in the total number of registered prospective observational studies were observed across the included European countries. The proportion of observational studies with respect to the overall prospective studies varied between the nations. Country specific sizes of pharmaceutical markets and regulatory requirements considerably influence the number of prospective observational studies.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PHP267
Topic
Health Service Delivery & Process of Care, Study Approaches
Topic Subcategory
Health Care Research, Registries
Disease
Multiple Diseases