Rare Disease Report

Registry Data-Who Really Owns the Data?

FEBRUARY 06, 2015

As president and founder of a patient registry company, I am often asked ‘who owns the patient provided data in your registries’. I always give the same response, “A patient owns their data and we should be kissing their feet for allowing us the opportunity to use it!”
People living with a rare disease are a critical component of the research process. Without patients and families voluntarily providing detailed insights into their rare disease, researchers may be missing information that is vital to unlocking scientific puzzles that may lead to new treatments.  An improved understanding of the burdens of living with a rare disease may help justify the funding required to advance therapeutic development. Pharmaceutical companies won’t invest hundreds of millions of dollars in research for a disease unless they understand how many people are affected, where they live, and how they are treated. In the rare disease community, patient registries are especially valuable to gather this critical information because in most cases, very little is known about a particular condition.

Everybody wants to share but the current system discourages it

There needs to be a single registry for each rare disease that is accessible to any researcher that needs the data. Unfortunately, that concept rarely leaves the hypothetical stage of development. Moreover, the incentive system for sharing the data is broken, resulting in the hoarding of patient data into proprietary research databases. For example, academic researchers are incentivized to collect patient data and keep it private so that they can get the next grant or prepare the next publication. Hospital systems can be reluctant to share data due to HIPAA and regulatory concerns. Pharmaceutical companies are incented to keep the data private to foster competitive advantage. Even non-profit advocacy organizations keep the data private in order to develop a resource that helps raise additional funds for their organization. These misaligned incentives lead to the creation of silos of patient provided information that too often die when a grant or research funding ends. And yet, we hear that patients want to openly share their information in a manner that has the greatest impact and longevity.

Informed Consent

So if a patient is the source of their own health information that is entered into a multitude of proprietary databases, who really owns the data and what can they do with it? An informed consent process may be used to ask the patient for their permission to collect data and to use it for a specific purpose. In research programs, an Informed Consent is typically reviewed by an Institutional Review Board (IRB) or ethics board to ensure that the patient is protected and understands the risks and benefits of participation, including who will have access to their data and for what purpose. That’s fine for controlling access within a single research study, but what if data is contained in a multitude of different registries and research databases, each with their own consent? As the information gets more and more fragmented, the patient loses control of their information. Organizations may argue for the patient data to be entered into their own proprietary database further fragmenting the patient population and making discoveries more difficult.  Each patient should be in control of their data, and that research databases and registries are most beneficial when they are patient-centered.

What if the patient really was at the center?

By providing a single patient registry that patients can join, PatientCrossroads provides a solution to the fragmentation of patient data. In a shared registry platform, multiple research studies can be presented to the patient, each with a custom IRB consent process the patient can voluntarily join. In this manner, there can be a single registry per disease; each research investigator or institution can collect their own study data in a single system, and patients can opt-in and opt-out of studies as they wish. When a research study ends, the data becomes publicly available, immediately providing benefit to the greater community. By establishing a single registry capable of delivering numerous research studies within a single database, the patient is returned to the center of research. 
Fortunately for those who live with a rare disease, the world is changing. With the advent of mobile devices and robust data sharing programs, there are outlets for a patient to better own their data. Those of us in the research and registry domains need to be reminded that it is the patient’s data and not our data. And we really should be more thankful and generous when patients grant us the privilege of learning from their experience. No need to literally kiss the patients’ feet but it is a step in the right direction.

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