The All of Us genomic study of the National Institutes of Health’s (NIH’s) Precision Medicine Initiative, which is expected to enroll 1 million people, has run into a problem in its pilot phase, Politico reports. About 30% of the people who have so far volunteered to provide their genetic material for the trial have not given researchers access to their electronic health records.
The study is designed to compare the participants’ health records with their genomic data to understand how each person’s genetic makeup, along with environment and other factors, may affect their health outcomes and their responses to specific treatments. So, without the health records, a person’s genetic material from blood and saliva is useless for research purposes.
All of Us researchers told Politico that some volunteers declined to provide their records because of concerns about privacy or because the hour-long online consent process was too arduous.
In a blog post on the All of Us website, Program Director Eric Dishman said, “The beta phase [of the research] has been very successful, uncovering what is working well and where we need to strengthen our platform and the participant experience and messaging.”
The program will launch a second, expanded beta phase in early November, Dishman said. A national launch is targeted for spring 2018, he added.
Three sets of healthcare providers in different regions recently received $13.8 million grants to enroll people in All of Us. They include a total of 18 healthcare systems and academic medical centers in Alabama, Florida, Georgia, Louisiana, and Wisconsin. Hospitals and health systems in California, Illinois, New York, and several other states are also participating.
The Walgreens drugstore chain will join the pilot in November, signing up volunteers in Phoenix and Sacramento, according to Politico.
Challenges
In June of this year, when All of Us launched its beta phase, Dishman predicted that 10,000 to 15,000 people would be recruited in the first 4 or 5 months. But according to Politico, only 4000 people have volunteered so far.
Another big challenge for All of Us will be to enroll participants who represent the genetic pool of the entire US population. In 2009, only 4% of 1.7 million participants in genome-wide association studies were people not of European descent, a Nature study found. A subsequent study in 2016 showed that the non-European percentage had climbed to 20%, but that still does not reflect the diversity of Americans.
Consequently, the All of Us program is trying hard to appeal to people from racial and ethnic minorities. The engagement of underserved populations is viewed as key to the program’s success.
Another thing the massive trial will need is lots of money. All of Us received $300 million in funding this fiscal year, and there is bipartisan support for the program in Congress, Politico said. But neither President Donald Trump nor former US Department of Health and Human Services Secretary Tom Price has mentioned the program, the article pointed out, and Trump’s attitude toward it is unknown.
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