Practitioners are increasingly being asked, instructed and/or incentivized to join data registries.  These collaborative solutions allow practitioners to capture, aggregate and correlate unique real-world data not native to their EMR/EHR systems, including patient-reported outcomes.  There is no shortage of solutions, many with dizzying levels of features, integrations, pricing models and clinical specializations.

The following article summarizes our decade’s worth of experience in developing, (failing) and ultimately succeeding in building hundreds of growing registries around the world.  In those ten years, we also have had a chance to learn a lot about the market, competitors, shifting regulations, and the nuances of evolving patient privacy policies, including the new Global Data Privacy Regulations.

We have distilled those experiences into 5 simple questions, whose diverse answers will surprise you, and ultimately help you make the best registry choice for you and your patients.

1. Who owns the Data?

The data is valuable, especially so when aggregated by many investigators against a shared protocol.  If you’re putting in the work, do you at least own the data?  The answer can be complex.

First, not all data are equal.  Information which clearly identifies the patient (Personal Information in Europe and Protected Health Information in the U.S.) is often considered exclusively “owned” by the patients themselves.  If a vendor claims that you own all data in a registry, it can be inaccurate and/or a direct breach of local privacy laws.  Therefore, your primary goal should ownership of anonymous or de-identified data sets.

Second, there are numerous stakeholders within a registry: investigators, patients, external funders and the registry vendor themselves.  You may be an owner of your data, or even more likely, a co-owner among many other stakeholders.  The GDPR recommends entering in an “aggregated data ownership agreement” to clearly lay out commercial and other rights among multiple stakeholders.  We recommend the same.

Lastly, ownership, monetary rights and distribution rights are three independent elements, each of which should be spelled out in an appropriate agreement.  What good is ownership if you can’t use it and/or don’t have a share in any monetary value?

In summary, don’t just ask “Who owns the data”, make sure you sure you understand the nuances around which data, co-ownership models, and rights with respect to ownership, monetization AND distribution.

2. What does it cost?

If you are participating in a registry, you will be dedicating time, energy and valuable staff resources to begin enrolling patients and entering data. Some registry vendors will additionally ask that you pay a license or other fee to use their solution.  You’ll have to therefore weigh the net costs: pricing, your time + staff time, against the perceived value of the registry itself.  

You will want to also consider the revenue model of each vendor.  All companies live and breath by profit, and their revenue model is a good indicator of where they will focus their time and energy.  For example, if they have high upfront installation fees, and low recurring subscriptions, you might expect excellent service initially, with low, cost-saving service and support longer-term. Look for revenue models which are aligned with the ways you obtain value.  The more aligned, the more incentivized the vendor is to help you extract the most out of your registry use and data.

Finally, some registries are made free to use by practitioners, with fees covered by grants and other third-party sources.  We think this is great, but make sure you re-read question 1 above.  Third-party funders almost always have exclusive rights to data ownership, monetization and/or distribution.

3. What can I get out of it?

Boilerplate answers will include data, engagement, collaboration, or even, “your colleagues are doing it.”.  If those sound fuzzy, unappealing and a far cry from immediate clinical, financial and professional value, you’re right.  

Proper use of registries can provide substantial benefits, but if your vendor can’t articulate those, then either you aren’t the beneficiary, or its up to you to put together all the pieces.  Here are three tangible benefits any registry should be able to offer:

Value and Reimbursement: Registry participation offers clear commercial benefits to its practitioners.  Through federally funded programs such as Merit-based Incentive Payment System “MIPS”, or grants through Industry or other third-parties, there are plenty of opportunities to earn compensation for your registry participation and time.  Choose a vendors who knows these opportunities, and can offer a clear pathway for how they can help you achieve those benefits.  

Professional Advancement: You should see a clear path for how the registry gathers data, data converts into evidence, evidence converts into insights, and how those insights directly improve your clinical, scientific and patient marketing objectives.  If you are only there to provide and access data, you are two-to-three steps away from actionable insights.

Expanded Academic Influence: Registries aren’t only an opportunity to collect data, but to also to collaborate and expand your academic influence amongst peers around the world.  If you are the 1,000th member of a large registry, you are helping the registry founders expand their own Academic influence.  Consider instead starting your own registry, with your own select group of collaborators, and earn your own expanded influence.

4. Is your solution flexible?

Registry flexibility is key for sustained or expanded adoption.  Conversely, inflexibility can add time or burden, decrease the value and relevance of your participation, and in many cases, be prohibitive to further use.

Every vendor will claim flexibility, but with so many potential areas to customize, are unlikely to cover all, including:

• Assessments
• eCRFs and Questions
• Follow Up Timepoints
• Branding
• Patient Communications/Experience
• Multiple Languages
• Data Sharing Settings
• Report Generation and Exports
• User Roles and Permissions
• eConsent Language
• PHI/PI storage
• User Authentication
• And much, much more

Make sure you know in advance the level of flexibility you need, how it applies to your goals (see question 3) and request the following three critical follow ups: can you do it, how long will it take, and will it cost extra?

5. Ask for a reference.

This is standard for hiring a new employee, but is conspicuously uncommon for choosing a registry solution.  If you wish to truly peer under the hood of any prospective technology, ask first to speak with a few of their clinical users, or even better, with those clinician’s staff members responsible for its use.  They will be refreshingly honest about the burdens, experiences and/or benefits they and/or their patients experience on a regular basis.  While on the phone, feel free to ask some of the questions above for fresh perspective.