As pharmaceuticals become more personalized to individuals’ specific genomes, drug developers must rely on medical data gathered outside clinical trials, known as (RWE), to learn how their treatments perform away from the strict confines of those trials.
“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 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.
This poses a real problem for pharmaceutical companies. More than of novel therapeutics approved by the U.S. Food and Drug Administration caused problems for patients after being approved and then marketed, according to . Another 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 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, , will allow users to safely upload medical histories, Fitbit activity and the electronic summaries of clinical care as , or CCDs. They’ll pay a small fee each month for the service, but they’ll be rewarded with ether () 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.
A recent of 1,200 cystic fibrosis patients and caregivers by CFTechnology.org found the overwhelming majority concerned about privacy and whether their data is sold. “I think blockchain has the security patients need,” Barnett says, “and PatientTruth gives the cystic fibrosis community constantly updated information about the genomics and characteristics of the condition itself.”
Paying for data encourages participation, Barnett says. By enticing more people to take part, the database becomes more valuable for drug developers and health care systems, which are Embleema’s ultimate clients. Although 43 percent of the survey respondents are willing to share their data for free or in exchange for a charitable donation, 53 percent want compensation.
Currently, 100 CF patients are participating in Embleema’s beta test of PatientTruth, as the company refines the user interface before officially launching its app. “They are pretty good at uploading their CCDs, but they still find the Ethereum wallet something of a challenge,” Normand says. “We’re working on making this seamless.”
Embleema is in its early stages, funded by friends and family. “We are staying away from the initial coin offering fundraising hype to focus on delivering a solution that solves an actual problem,” Normand says.
Eventually, Embleema plans to make its PatientTruth database available to other stakeholders, such as drug developers and health care systems to help them develop better therapeutics or choose the best drugs for particular types of patients.
“For this approach to work, we must bring together stakeholders – patients, patient associations, hospitals, drug developers, and regulators – with shared interests in trading information that has monetary value,” Normand says.