Gail Dutton

As pharmaceuticals become more personalized to individuals’ specific genomes, drug developers must rely on medical data gathered outside clinical trials, known as real world evidence (RWE), to learn how their treatments perform away from the strict confines of those trials.

One company, Embleema, wants to use blockchain technology to make gathering that data easier.

“Current methods of gathering RWE are slow and imprecise because they pull aggregated databases from health data brokers and don’t actively involve patients,” Alexis Normand, head of the Embleema Consortium, tells ThirtyK.

People also are unwilling to share personal data over unsecured networks, or to relinquish control over who sees it. Among cystic fibrosis (CF) patients, “many have clinical trial fatigue,” Jeanne Barnett, founder of the CF patient advocacy organization CFTechnology.org tells ThirtyK. Even when people are willing, there’s been no easy way to share that data.

The security inherent in blockchain lets users manage how (or whether) their data are shared and who accesses their records.

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This poses a real problem for pharmaceutical companies. More than 30 percent of novel therapeutics approved by the U.S. Food and Drug Administration caused problems for patients after being approved and then marketed, according to one study. Another study found one-third of new FDA approvals were given based on just one pivotal trial and that more than one-third of newly approved treatments had no postmarket clinical trials.

This suggests a lack of sufficient data during development that could have provided insights about drug interactions, genomic factors and other details affecting drug performance. To fix this, the FDA is evaluating blockchain technology as a way enabling the secure exchange of large amounts of health data.

Paying for Data With Crypto

Embleema’s health records blockchain, PatientTruth, will allow users to safely upload medical histories, Fitbit activity and the electronic summaries of clinical care as continuity of care documents, or CCDs. They’ll pay a small fee each month for the service, but they’ll be rewarded with ether (ETH) when they upload data and be rewarded even more for agreeing to share their data (in anonymized form) with researchers. The security inherent in blockchain lets users manage how (or whether) their data are shared and who accesses their records.

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