2012: The Year of the Patient Registry?

Posted 13 December 2012 | By

Patient groups, regulatory agencies and companies are increasingly finding use in the establishment of patient registries-databases of patient data usually specific to a particular disease, and often including genetic, health, demographic and other information.

One of the earliest adopters of the registry model was the Cystic Fibrosis Foundation, which established a registry in the early 1970s to better assess information about the relatively small number of patients living with cystic fibrosis. The database now numbers more than 27,000 patients, and has been instrumental in bringing new therapies to market.

2012 has proven to be something of a banner year for registries in the US. The Association of Healthcare Research and Quality (AHRQ) announced that it would establish a registry of patient registries to keep track of them all under a system modeled after the ClinicalTrials.gov website, which tracks-what else-clinical trials. The goal is, like the clinical trials registry, to reduce the amount of duplication of registries and efforts, and to promote the consolidation of those efforts where and when possible.

The US Food and Drug Administration (FDA), meanwhile, has announced that it is seeking to establish its own patient registry to assess the risks of imaging contrast agents, which it said are associated with nephrogenic systemic fibrosis (NSF), a condition that causes excessive connective tissue to form inside a person's internal or external organs. Given the risks of serious and fatal side effects associated with exposure to the agents, developing "reliable knowledge" is key, FDA wrote in an 18 July Federal Register posting.

The National Institutes of Health (NIH) has also gotten into the mix in 2012, announcing the launch of a Down syndrome registry to "facilitate contacts and information sharing among families, patients, researchers and parent groups."

Now, at least one pharmaceutical company is getting into the mix as well. On 12 December, French pharmaceutical manufacturer Sanofi announced it will begin a $300,000 collaboration with an initiative known as "Registries for All Diseases," (Reg4All) a group which hopes to create a "comprehensive, crowd-sourced, cross-disease registry to help accelerate translational research for over 1,000 diseases."

Reg4All is a collaboration between several patient groups, including the Genetic Alliance, CFIDS Association of America, National Psoriasis Foundation and the Inflammatory Breast Cancer Research Foundation. "Thousands" of other groups are also involved in the initiative, the group said in a press statement.

"In a nutshell, our team seeks to create a cross-disease, systems biology-based, crowdsourced, long tail, aggregated resource critical to advancing translational research on more than 1,000 diseases," it said. "Registries for All Diseases accelerates translational research by linking clinical information and samples in a dynamic registry that allows re-contact in a trusted environment. Because Registries for All Diseases breaks down the silos between diseases, it allows for advanced research into comorbidities stretching across seemingly unrelated diseases."

"Creating a registry of patients is the single most valuable action a rare disease community can take," said David Meeker, president and CEO of Genzyme, a subsidiary of Sanofi. "The registry provides critical disease knowledge which makes that disease easier to study, increasing the probability a treatment can be developed."

The move marks at least the second time this year Sanofi has teamed up with patient groups. In April 2012, it teamed up with the Michael J. Fox (MJF) Foundation, a Parkinson's disease advocacy group, to test a new treatment aimed at treating the disease while leveraging the MJF Foundation's "Fox Trial Finder," a clinical trials location tool specific to the disease.


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