OBJECTIVES: Summarize the results of a survey conducted by EUCROF (European Contract Research Federation) Late Phase Working Group in major European countries in order to evaluate the heterogeneity across different countries in terms of definition and regulation of clinical observational studies.

METHODS: A questionnaire was distributed to members of EUCROF. Questions were addressed to investigate local authorization processes and to explore the country compliance in terms of definitions, methodological standards to the latest EMA regulations, ENCEPP guidelines and other international standards.

RESULTS: Responses from seven European countries have been analysed and reveal great heterogeneity.

The authorisation processes vary considerably in terms of duration (2 to 32 weeks – average: 15 weeks) and costs (free of charge for 3 countries – 75,850 euros on average for the others).

Heterogeneity exists within local regulations, 4 countries of out 7 have local regulations that are consistent with the definition of EMA and only 1 country with the definition proposed by ENCePP. In 6 countries, there are no specific regulations or procedures for conducting observational studies that allows the addition of diagnostic or monitoring procedures specific to the study.

All countries are compliant with GDPR regulations. While the majority of countries comply with the PASS/PAES and Medical Device European Directives, not every country has local regulations which stipulate these should be followed. Similarly, local guidance regarding adhering to ENCEPP and Strobe Guidelines varies.

CONCLUSIONS:

Post-authorization observational studies are often required by health authorities and data from real world evidence is now crucial for market access. Despite this, regulations in different European countries do not have common rules and definitions, and remain mostly based on directives rather than laws. Thus, conducting European observational studies in this non harmonized environment is a challenge. In order to homogenise practices, it is important to minimise the heterogeneity between EU countries.