 pilot on the analysis of raw clinical study data){kind=link}
EMA published on its website the interim report of the still ongoing proof-of-concept (PoC) pilot on the analysis of raw clinical study data voluntarily submitted as part of the dossier to support marketing or post-marketing authorisation applications. The pilot started in September 2022 and counted five regulatory procedures activated until December 2023.
The higher benefit for participants is linked to the statistical analysis of clinical data for more complex dossiers and products. The survey highlighted in 83% of cases an added value of accessing clinical study data at the time of submission with reference to improved understanding of the set of information in a product dossier, a reduced list of questions to applicants/MAHs, the promotion of multi-disciplinary teamwork and a better consensus on methodological issues among regulators. The development of a knowledge base for the review of experience to guide the assessment of future studies has also been indicated.
Added value was also highly perceived (93%) for GCP site inspections, leading to a shorter time to plan and conduct inspections and optimisation of resources across the European regulatory network. The interim report addresses learnings gained during the first phase of the project and highlights consequent recommendations to be implemented in the second phase.