Top Tips on setting up a Registry

Are you a health economist aiming to gather data for an HTA submission? Or a Medical Affairs director looking to gather post-marketing surveillance data for a drug or medical device? Or simply trying to understand the current standard of care for a disease area?

Here are Cisiv’s top tips on setting up a registry:

Start with the end in mind. What is the purpose of the registry? Is it to determine prevalence or incidence of a disease or both? Is it to gather evidence on cost effectiveness of a treatment? Try and formulate a clear question that you want answered.

Understand who will be entering the data into your registry.  If it’s a hospital physician, general practitioner, or hospital nurse, data entry can pretty dull and boring to them.  Even if they are compensated for their time, the job is not exciting. So, take time to understand how they work and find ways to make the job easy and relevant for them.

Understand the patient pathway. A registry is about gathering data that follows the patient through the ‘standard of care’, which means it could vary from one country to another if you are running an international registry. Spend some time understanding the standard of care in each region or market. Your registry will need to have protocol variations to reflect these differences.

Engage with all stakeholders early.  If you are sitting in a large (or small) biotech, pharma or medical device company, it is likely that you will want input from different stakeholders: medical affairs, safety, regulatory, epidemiology, key therapeutic expertise, health outcomes, biostatistics and data analytics etc.  Securing approval and input from all the different groups can take a long time and create project delays. Engage in discussions early and decide on a process to build consensus.

Upgrade your EDC platform. Most registries have moved from paper to electronic data capture.  If you are still using paper, it’s time to consider upgrading to a more efficient process. If you are using an electronic data capture platform (EDC), take some time to understand the technology; not all EDC are born equal. Most EDCs on the market were designed for clinical trials and are not optimised for registries. Good usability is crucial to keep physicians engaged. Your technology platform should support efficient data collection and analysis; if not, it will require a lot of data cleaning and make it complex and expensive.

Keep it simple.  Don’t complicate the protocol.  You are dealing with busy research-naive physicians or patients (in the case of patient-led registries), not research investigators.  Keeping it simple will lead to high quality and complete data. 

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