The European Medicines Agency (EMA) launched a public consultation on the basis of a discussion paper focusing on the “use of patient disease registries for regulatory purposes – methodological and operational considerations”.
The proposal discusses methodological and operational aspects of patient disease registries and makes proposals on what might be considered good registry practice to support the collection of high quality registry data.
Patient registries are organised systems that use observational methods to collect uniform data on a population. They can play an important role in monitoring the safety of medicines.
EFA welcomes this EMA discussion because of its important link with Real World Data collection and the most universal scope on disease prevalence, development and patient behaviour. We are also glad to see that EMA acknowledges the key role that Real World Evidence can play in decision-making.
EFA main points to EMA public consultation on patient registries
EFA participated in the public consultation by pointing among many others the following aspects:
- EFA strives for a one-disease registry in Europe. Allergy and asthma constitute examples of umbrella diseases involving conditions that present great variations in terms of severity, symptoms, time elements etc. and therefore common terminologies and common core data necessary to improve understanding and ensure comparability, transferability and exploitability of data.
- EFA highlights the need to clarify whether registries should differentiate between input data coming from self-patient reports and/or medicinal reports. This distinction is crucial not only for good registry management practice, but also to assess unmet care needs or inaccurate patient information. This is extremely important in chronic non-communicable diseases such as allergy, asthma and COPD, where patients may occasionally overestimate or underestimate their reaction and provide biased input.
- EFA is glad to see the EMA discussion paper stresses that patients remain in control of the use of their data, and that they need to be fully aware of why, what, how and by whom their data are collected, and with whom it is shared.
The full response to the EMA consultation on patient registries can be found here.
We thank all our Members from the EFA Food Allergy, Allergy and Asthma, Atopic Eczema, Patient Education and COPD Working Groups for their input and to put this response together.