When exploring the idea of establishing a registry for your organization, the prospect can be daunting and the options, seemingly endless.
There are a range of options available, costing from next to nothing up to millions of dollars, with each having pros and cons, making deciding which option to choose even more difficult.
In this article we will explore some of the reasons you might wish to start a registry and the various products/tools available.
Contact registry
A contact registry, in its simplest form, is a database of patients’ contact details that you have collected, usually for the purpose of contacting them with information that is relevant to their disease. In some cases, you may also collect basic details about their disease and any subtypes. Most support groups will have a contact registry of some description that they use to send regular communications; this could be a spreadsheet, Customer Relationship Management (CRM) software, or through an automated email provider such as Mailchimp.
Tools for Contact Registries – Spreadsheets
Spreadsheets created in Microsoft Excel or Apple Numbers are a good starting point for collating information and data about patients, their condition, and previous treatments, all at little or no cost. This will provide you with a basic contact registry to begin your data journey, serving like a phone book or mailing list with details of the patients who have consented to being part of research.
However, there are some obvious drawbacks to using spreadsheets, especially as your registry grows and becomes more complex. As the requirement for more complex data sets grows, your registry needs react dynamically and include input from a range of stakeholders. Even for the most spreadsheet-savvy users, it can be difficult to manage privacy and data protection concerns as well as input from multiple sources with potentially different formatting and units.
Cons
- not flexible as needs grow
- difficulty in managing consents and General Data Protection Regulation (GDPR)
- data not regulated for use in research
- data not mapped to an acceptable data standard
- costly to migrate if you outgrow its functionality
- single stakeholder input
- cannot benefit federated data projects.
Pros
- simple
- low or no cost
Advanced Contact Registry Solutions
There are now a range of low-cost, ‘DIY’ database systems available online that will provide you with additional functionality over a basic spreadsheet and may pose an attractive option.
Services such as Zoho provide a free, cloud-based database service, allowing for collaboration and detailed data pulls; however, there may be issues if and when you choose to migrate to a different platform and, if they were to go out of business for any reason, you may lose access to your data permanently. Paid systems such as Microsoft Dynamics are another option which allow for customization, but the interface can be clunky. Also, they may require specialist knowledge to make material changes to data collection and output.
Cons
- data not regulated for use in research
- single stakeholder input
- costly to migrate if you outgrow its functionality
- difficulty in managing consents and GDPR
- data not mapped
- cannot benefit federated data projects.
Pros
- more flexibility than a basic spreadsheet
- low cost
Disease Registry
A disease registry contains more in-depth data about a specific disease, including ongoing or completed research, results of clinical trials and natural history data regarding specific patients. These also require more specialized software and additional layers of security. Disease registries are usually commissioned for specific study projects and are most often owned by the academic institutes carrying out the study.
Tools for Dedicated Disease Registries
If you are considering a bespoke solution, some providers can design, build, and manage your registry for you specifically. This includes gathering and refreshing patient consent, soliciting contributions from researchers and physicians, and ensuring your data is secure and available whenever needed. Some registries are also multi-tenanted, accepting data input from multiple stakeholders, such as clinicians, researchers, and patients.
While this all sounds great, there is a big drawback—the cost. Registries from these providers can cost millions of dollars per year, and some such systems may even require you to buy back your data should you choose to migrate to a different provider.
Understanding costs up front can also pose a challenge. Before you receive a price, you will need to consider and decide on the wide range of variables and functions you would like your registry to have. You need to clarify your needs and invest time in developing a plan with a provider.
However, if your organization has the funds and plans on staying with one provider for the long haul, then this type of service may work for you.
Cons
- cost-prohibitive
- complicated
- understanding data ownership
- no access to data once study has finished.
Pros
- multi-tenanted platform, allowing multiple users
- support in controlling consents and GDPR
- can be used for federated data, accessible globally
- regulated data
- data may be mapped to various regulatory standard
Modular Real-World Evidence Generation Platforms
Real-world evidence is becoming an essential part of accelerating research, and patient groups are at the forefront of providing this valuable data. However, the prohibitive costs of disease registries mean most patient groups cannot realize this value. A modular platform that allows patient groups to start small but also grows with their needs and funds can be a great way to get started. These products offer scaled-down versions of their full registry counterparts, with the same support for consents and GDPR and high-quality regulated data. Some may also have mapped data, essential if you want to apply your research to drug development. All will have the ability for growth and added complexity without the need for expensive migration.
Cons
- requires input from patient group
- starting module may be too limited for some.
Pros
- cost-effective
- modular, so grows as needs do
- regulated data
- mapped data
- can be used in federated data accessible globally
- allows patient groups to control and own data
- support with understanding registries
- support in controlling consents and GDPR
- single tenant growing to multi-tenant.
If you would like to find out more about the suite of modular evidence generation platforms powered by healthie, then contact our Head of Clinical Product Management, Nina at nliu@pulseinfoframe.com, or visit www.pulseinfoframe.com.
