Patient registries, sometimes called patient databases, are a useful tool in any clinical trial patient recruitment strategy. They help researchers quickly identify potential study participants who may meet trial eligibility requirements and have raised their hand as interested in participating in research. In addition, they assist with ensuring that the patient pool is representative of the population being studied. With so many registries available, it can be challenging to know which one might work best for your particular study. Here, we discuss some key factors to consider when selecting a patient registry for clinical trial patient recruitment.

Key considerations

Study design and patient population: The first step in selecting a patient registry is to consider your study’s design and the patient population you are studying. Are you conducting a rare disease study with a genetic component, or is the condition prevalent in the general population? What age range are you targeting? What comorbidities do you need to consider? These factors will help you identify the registries that contain the relevant patient populations. Of note, if you are running a trial that requires participants with a specific genetic makeup, you’ll need to ensure the registry includes this information or that there is a way to obtain it.

Data quality and completeness: The quality and integrity of the data in the patient registry are critical. It should have accurate and up-to-date information on patient demographics, medical history, and other relevant clinical information. It is also important to understand how the database is updated and maintained to avoid missing data or inaccurate information.

Data privacy and security: Patient privacy and security are paramount in clinical research. The registries you consider should comply with all relevant data privacy regulations, such as GDPR and HIPAA. You'll need to assess the registry’s security measures and ensure that patient information is encrypted and protected from unauthorised access. This should be a question that a representative of the registry should be able to answer with ease and confidence.

Accessibility and ease of use: The registry should be easily accessible and user-friendly. Researchers should be able to search for potential study participants based on specific criteria and retrieve patient information quickly and efficiently. Ideally, the database should also have a user-friendly interface that allows for easy data entry and retrieval.

Cost: The cost of gathering patient information from a registry can vary widely, depending on the size of the database and the level of access required. Some registry organizations charge per patient, while others have a flat fee or subscription model. It is important to assess the cost of using a patient registry and ensure that it fits within your study budget.

Regulatory compliance: Of course, it is key to ensure that the patient registry is compliant with all relevant regulatory requirements, such as FDA and EMA regulations. The company that owns the registry should be able to provide the necessary documentation to demonstrate compliance and provide proof that its patient data can legally be used in clinical research studies.

Conclusion

If you’ve decided to use a patient registry as part of your clinical trial patient recruitment strategy, it’s critical to select the organisation you partner with thoughtfully. To ensure success, researchers should evaluate various factors, including study design, data quality and completeness, data privacy and security, accessibility and ease of use, cost, and regulatory compliance. Selecting the best patient registry for your trial will enable you to quickly fill your study with participants, and ultimately drive your research towards meeting its objectives. 

If you’re conducting a precision medicine clinical trial, Sano can help you conduct outreach to the right patients, and build your own registry. Get in touch to learn more.