In the Exploration Phase the EMA is interacting with the Coordination Centre to explore the feasibility of a study request with respect to the preferred design, available data, resources, and timelines.
1. Study Request
Research questions originate from the EU Regulatory Network as a need for information to support the authorisation and monitoring of medicinal products and subsequent decision-making. They may include, for example, queries on the incidence or prevalence of disease in the European population, the drug utilisation patterns for a specific product, the collection of additional data on a potential safety signal, the evaluation of an association between a drug and a clinical outcome or the assessment of the effectiveness of a risk minimisation measure. It is envisaged that in the future, research questions may also originate from other stakeholders such as the European Commission, the European Centre for Disease Prevention and Control (ECDC), Health Technology Assessment (HTA) bodies and payers.
The requester, together with EMA, prepares the Feasibility Assessment Form containing: a short title for the request, the regulatory background motivating the query, any other important information for understanding the query, the product and/or event(s)/outcome(s) of interest, the objective, a proposal for the study design and any relevant design considerations such as the choice of data sources and other methodological aspects. The choice of study design is supported by the Catalogue of Standard Data Analyses providing, for a range of possible analyses with different levels of complexity (Routine repeated, Off-the-shelf, Complex), the implications in terms of databases needed and timelines.
2. Feasibility Assessment
The Coordination Centre then performs a feasibility assessment for EMA review. Its aim is to assess the feasibility of the study based on relevant factors for the concerned study, including, for example, the number of exposed patients, number of events, time period, minimum duration of exposure to be considered, time lag for occurrence of event, feasibility of implementing the study design in the available databases or other criteria depending on the study. The feasibility assessment will in principle only use information already available to CC on the characteristics of databases via pre-calculated Data Dashboards and other relevant information.
If necessary, simple data analyses could be performed in relevant databases available, for example simple count of the number of patients exposed to a medicinal product or who experienced a clinical event over a defined time period. Such data analysis may be performed in a limited number of databases by the Coordination Centre and will not undergo the same quality assurance process as those performed for a full study.
The results of the feasibility analysis are next included in the Feasibility Assessment Form with a recommendation regarding the conduct of the study. The decision to initiate the study is formally made by the EMA.