ABSTRACT
The European Medicines Agency provides Scientific Advice to medicines developers and patient input has been an integral part of this process for many years. As end users of medicines, patients bring their perspectives to many different processes along EMA’s regulatory pathway, complementing the scientific expertise. While the value of including patients has been well-demonstrated over the years, requests for evidence of their impact continue. Using Scientific Advice as a case study, data was collected over a four-year period to assess the number of patients involved, where they contributed, as well as the impact and added value of their input. In this paper, we show that patients’ contributions have a tangible impact on the recommendations provided to developers and in over half of the cases, this led to further discussion on relevant patient perspectives. These data provide quantitative evidence of the value of patient input in medicines development and supports EMA’s continued inclusion of their voice throughout the medicine’s lifecycle.
CITATION
“The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study”, Murphy Aisling, Bere Nathalie, Vamvakas Spiros, Mavris Maria, Frontiers in Medicine, Volume 8, 2022, DOI=10.3389/fmed.2021.811855, ISSN=2296-858X
COMMENT
This article is very interesting because it details what areas patients mostly commented on (see below) and whether the EMA’s recommendations were modified as a result of patient input. Results show that input resulted in further reflection in 52% of cases and the final advice was modified in 20% of cases. Where the patient input did not change the final advice it was in the vast majority of cases because they agreed with the proposed development plan, say the researchers.
Areas patients most often commented on:
- selection of the clinical trial population (49%)
- choice of endpoints (48%)
- study feasibility (52%)
- QOL studies (48%)
- bringing in a real-life perspective of living with a condition (as patient or carer)
- general insights into the condition, its daily impact and treatment options.
Posted by Pisana Ferrari
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