On the 25-26 of January, EFA was invited by the European Medicines Agency (EMA) to participate in the Accelerating Clinical Trials in the EU (ACT EU) Workshop. ACT EU aims to develop and innovate clinical research in the EU, and that is paramount for allergy, atopic eczema, asthma and chronic obstructive pulmonary disease (COPD).
What are the common uses of clinical data in the EU?
Over the years the EU regulatory network has been collecting data about clinical trials in the EU through clinical trial registries and instruments such as CTIS and EudraCT. However, the existing platforms do not share clinical data per se.
There is a wealth of clinical data that is developed during trials for medical innovation across medical conditions. The information is used to support regulatory decision-making, authorising new medicines for example. It also serves to track healthcare innovation or even exploring the use of Artificial Intelligence for novel insights in the field. However, clinical data has a huge potential to improve health and extends far beyond the current scope of use.
Data and patients – why is health data important?
While clinical data used for trials is developed mostly to respond to a research hypothesis, there are many indicators in data of patients participating in a trial that could serve other research hypothesis, linked to severity, comorbidities, quality of life or even the connection with environmental exposure and the climate.
The ACT EU event brought together different stakeholders including patients, researchers, industry representatives and policymakers in Amsterdam to discuss how data can be used to support and guide EU decision-makers in improving access and usability of clinical trials data.
New uses of data – ACT EU workshop
Making clinical data accessible across Europe and actors advance research requires a well-regulated framework and information to patients on secondary use of their health data, so that they can make informed choices.
The ACT EU workshop served to share use cases based on access to clinical trials data, data analysis, and funding. EFA participants Isabel Proaño and Agata Papotto, pointed out the evidence gaps within the European clinical trials environment including the limited use of clinical research findings for wider population interventions, or the potential for a better analysis of the impact of vaccination and the use of antibiotics.
The workshop provided an opportunity to get more information on how international data standardisation efforts on clinical trials led by ICH M11 are enabling new use cases and support implementation.
A key outcome of the workshop will be a research agenda proposal by EMA that will include a prioritised list of use cases for data analysis as discussed by the different stakeholders in the workshop, including EFA. It was a great opportunity to become part of a growing community on clinical trial analytics on the ACT EU multi-stakeholder platform.
More details can be found here: ACT EU Clinical Trials Analytics Workshop - January 2024 | European Medicines Agency (europa.eu)