What is a patient registry, and what role do they play in precision medicine clinical trials?

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Back in 2015, a study published in Nature suggested that by harnessing genetic data to support the selection of candidate drugs, researchers could double their success rates. Considering that only around 10% of clinical programs ultimately result in an approved drug, using genetic data can be game-changing for drug development. Patient registries serve as repositories of genetic information that can be used during precision medicine trials to help us better understand medical conditions and why people react to treatments differently. In this blog, we’ll define genetic patient registries and discuss how they support research and what to keep in mind if you're considering making use of one.

Genetic patient registries: A snapshot

Genetic patient registries, also known as disease or clinical data registries, are sophisticated databases designed to house comprehensive genetic and clinical information about patients with specific medical conditions. These registries act as purpose-driven collections of data, organised to serve predetermined scientific, clinical, or policy objectives. A registry will usually capture patients' clinical statuses, medical histories, laboratory results, and more. Some examples of patient registries might be those focused on rare diseases, cancer subtypes, or primary immune deficiencies.

The purpose of patient registries is to assist healthcare practitioners in formulating optimal treatment strategies for individual patients or specific groups. They can also:

  • Provide data to develop therapeutics or to learn about population behaviour patterns and their association with disease development
  • Help develop research hypotheses
  • Support quality health care and personalised treatments

The benefits of genetic patient registries

Using genetic patient registries speeds up patient recruitment, screening – and ultimately enrollment into precision medicine trials. With pre-existing genetic data readily available, researchers can swiftly identify potentially eligible candidates, reducing the time that's usually spent on recruiting suitable participants. Because genetic and other clinical data is known, further screening is also less extensive and time-consuming, which minimises cost and makes trials more affordable. Considering that the median cost of bringing a new drug to market is estimated to be $985 million and the average cost is $1.3 billion, this can be vital for helping get new treatments to market. 

Navigating challenges

While genetic patient registries have many benefits, they can also pose challenges for pharmaceutical and biotech companies seeking to advance precision medicine. Firstly, these registries often suffer from fragmentation, with data scattered across various institutions, databases, and formats, making it difficult to compile a comprehensive dataset for research. Furthermore, ensuring data privacy and compliance with increasingly stringent regulations, such as GDPR and HIPAA, can be a complex and resource-intensive process, posing a significant hurdle for accessing valuable genetic information. Additionally, issues related to data quality and completeness can hinder accurate patient stratification and the identification of suitable candidates for clinical trials. Lastly, the evolving landscape of genetic research necessitates staying current with emerging technologies and analytical methods, which adds an ongoing challenge. Overcoming these challenges requires collaborative efforts, innovative data integration solutions, and a commitment to ethical data handling, all of which are critical for advancing precision medicine.

Ethical considerations

Genetic patient registries contain sensitive information about individuals' genetic makeup, posing concerns related to privacy, consent, and data security. A robust informed consent process is one of the most important parts of using or creating a registry – this means transparency about data collection, usage, and potential risks. Striking a balance between the collective benefits for research and each individual’s rights over their genetic data remains an ongoing dialogue, and discussions about genetic information ownership and control need to be brought into focus in order for patient registries to be created and used ethically.


Genetic patient registries can be very beneficial for precision medicine clinical trials. These registries streamline patient recruitment, reduce screening costs, and expedite research efforts. However, they come with their share of challenges, including data fragmentation, privacy concerns, and evolving research methodologies. Despite these obstacles, the potential benefits are substantial. As we continue to harness the power of genetic patient registries, it is imperative that we navigate these challenges ethically and responsibly, ensuring transparency, informed consent, and data security to strike the delicate balance between advancing medical science and respecting individual rights and privacy.

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