Patient registries are a powerful tool used to collect, store and analyze longitudinal health data to support evidence-generation. By bringing together anonymous, structured and unstructured data from multiple sources, they provide invaluable insights into real-world trends, outcomes, and the experiences of patients with a particular disease or condition.

Despite their underexploited potential, patient registries can be used for a range of clinical and real-world evidence (RWE) settings to support regulatory decision-making, including uncontrolled clinical trials, post-approval safety studies (PASS) and post-approval exposure/effectiveness studies (PAES). They can also provide valuable insights into rare and orphan diseases that are otherwise difficult to study due to limited patient populations. The potential for patient registries is even greater, due in part to new technologies, such as digital platforms and sensors, that can support more detailed monitoring of health and therapeutic outcomes. On the top of that, multi-language AI can be an incredibly useful tool to overcome language barriers; by using natural language processing (NLP) algorithms, AI can identify patterns, trends, and correlations in the data, even when the data is in multiple languages.

However, a number of factors impede the successful adaptation of patient registries. The cost of setting up and maintaining a registry is significant, and there is a risk that the data collected may not be representative of the target population. One of the key challenges is acquiring accurate and consistent data about patients. This information needs to be consistently updated in order for the registry to be effective. Moreover, data privacy and security are becoming increasingly important factors that must be taken into consideration. In Europe, appropriate measures need to be taken in order to comply with the General Data Protection Regulation (GDPR). It’s important that the registry is compliant with GDPR regulations and that patient data is collected safely and securely.

In order to encourage their adoption, the European Medicine Agency (EMA) recently launched a patient registries initiative to enhance the development and use of patient registries across Europe, as well as promote international collaboration and harmonization. Other regulatory authorities are also advancing their use in the clinical arena, such as the FDA in the US; the FDA’s Patient-Focused Drug Development (PFDD) program offers a platform for patients to share their perspectives on the use of innovative treatments and therapies.

Evidilya, the global full-service CRO, has a wealth of experience working with patient registries, and is well positioned to understand the key principles, technologies and data processes needed to ensure the efficient and successful deployment of patient registries. With our support, these powerful resources are poised to deliver invaluable insights across a wide range of clinical and real-world settings.