Patient registries and their role in clinical development 2

Do you donate blood? Or perhaps you’re an organ donor. If so, you see the value in contributing – literally, a part of yourself – to the greater good. In addition, you may see the potential direct benefit for you or those you care for. Blood and organ donations are now common practice, and it’s easy to see that their value is irrefutable.

What if we extended this concept to data about diseases. Patient registries are ways to bring data together to be used to understand disease, identify clinical trial participants, and, potentially provide statistical power to help develop new disease treatments.

What’s a patient registry?

What are patient registries and how can they be useful in the clinical development space?

As Wikipedia states it:

A patient registry is a collection of secondary data related to patients with a specific diagnosis, condition, or procedure.

When designed properly, registries act as a bank of patient health data and can provide a real-world view of clinical practice, safety data, health outcomes, disease progression and effectiveness of clinical treatments. Here are some examples.


Reg4All is recent example of a patient registry that shows promise to advance research and discovery of new treatments for disease. In December 2012, Reg4all won the Collaborate Activate Innovate Challenge and was awarded $300,000 for creating a registry that crowdsources disease information to accelerate translational research.

There’s a good chance that there’s a landing place in Reg4All for your patient data, as the registry covers over 1,000 different diseases. Additionally, the registry puts the power in patients’ hands by allowing data contributors to choose how their data is used for medical research.

Reg4All’s emphasis on privacy controls and patient consent is unique. While many biobanks and DNA databases have participants sign broad consent forms that leave them little control over data, Reg4All allows patients to fine-tune how their information is used—sharing it with particular researchers, institutions, or people studying a specific disease. They will also be able to track who uses their data and how.

National ALS Registry

Launched in October 19, 2010, the National ALS Registry is hosted by the Center For Disease Control (CDC) and is the result of a congressional mandate. The registry is for ALS patients to self-enroll their data with ultimate goals to find causality, treatment, and cures for ALS patients. The registry provides clinical trial information, ALS clinic information, fact sheets, and reports and journal articles.

@ALSAdvocacy refers to why, for ALS, a patient registry is vital in a recent blog post:

Information lost in the fight against ALS makes it the disease where new patients constantly have to re-invent wheels. Information lost also means that scientists often ignore some of the simple things that past patients have found helpful. This is a dreadful waste.

More on benefits to R&D – PatientsLikeMe

So how is patient registry data being applied in the research and development setting?

PatientsLikeMe leverages their social network to build the PatientsLikeMe ALS Public Registry. Through a combination of self-enrollment and survey interaction with their patient community, PatientsLikeMe has created a self-learning healthcare system. As Paul Wicks, Director of R&D at PatientsLikeMe, sees it:

I can push a button and survey 200 ALS patients and get results in two weeks…I want an electric sensor on your head, in your toilet, on your pancreas, on your steering wheel, and in your Google Glasses.

The PatientsLikeMe platform can be used as a registry by industry and non-profit research researchers, for access to patient-entered data, patient matching for basic research and clinical trials, and drug safety and pharmacovigilance information.

PatientsLikeMe was recently given a $1.9 million grant by the Robert Wood Johnson Foundation. The grant is designed to utilize health outcomes data for various medical conditions with hopes to impact clinical trial design.

What are the challenges involved with patient registries?

There are challenges associated with the continued emergence of patient registries.

One concern with so many registries popping up is that their value could be limited in ways similar to how electronic health records are currently limited. There’s risk of a preponderance of multi-siloed registries, lacking sufficient data interoperability. Bringing interoperable data standards to registries can help.

At some point, if you have multiple, divergent, separated patient registries for a disease, the statistical power and value proposition association is diluted – if you have too many silos of registries, you really don’t have A REGISTRY.

Data quality can become an issue as well, and  bridging to EHR systems themselves are ways for precision and accuracy to be sustained among patient registries.

Additionally, it’s imperative that registry environments have tight monitoring controls to assure patient privacy is kept secure while eliminating the risk of attacks from cyber hackers. As mentioned above, registries are tackling these issues.

As there’s tremendous opportunity for patients to contribute data and knowledge that has yet to be fully harvested, I would be interested to hear about your thoughts and concerns on the use of patient registry data and its applied use in the research and development settings.


  1. You might want to look into the NIH Global Rare Diseases Registry, RD-CONNECT European union initiative and PatientCrossroads CONNECT which is used to power these programs. The organizations you describe above cut out the patient advocacy organizations – the trusted source to patients – we strongly believe a deep partnership with advocacy is required to have a successful registry program.

    • Thanks for your response Kyle! Your feedback is very much appreciated. Those are great examples. Patient advocacy groups are a key component as well. They’re backing is important to for bringing registry data to fruition for patients to consume and utilize.

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