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23andMe, TrialSpark Partner on Clinical Trial Recruiting

Saliva sample kit

23andMe saliva sample collection kit (23andMe)

26 Sept. 2019. A new collaboration of a genetics testing company with a clinical study site contractor aims to broaden and speed-up enrolling individuals in clinical trials. Financial details of the partnership between 23andMe in Sunnyvale, California and TrialSpark in New York were not disclosed.

TrialSpark and 23andMe say their partnership aims to make it easier for more people to take part in clinical trials by making available their companies’ services to study sponsors in a combined package. TrialSpark offers a technology and support package to medical practices that the company says makes it easier for physicians and clinics to participate in and recruit their patients for clinical trials.

23andMe is a consumer genetics testing company with some 8 million customers, and 80 percent of them indicating a willingness to take part in further research, according to the company. Moreover, says 23 and Me, its customers keep in contact with the company with 60 percent of its customers logging-in to their accounts in the past 90 days.

The partnership calls for TrialSpark to offer its network of practice-based clinical trial sites, with 23andMe offering its databases for recruiting and screening participants. The screening process includes finding patients with medical and demographic characteristics needed for specific trials, as well as genetic characteristics to ensure ethnic diversity and pharmacological suitability. The TrialSpark technology also accesses patients’ electronic health records to match an individual’s medical history to a clinical study’s requirements.

Once a trial is underway, TrialSpark’s system captures and manages data in a standardized format. And the 23andMe platform, says the company, makes it possible to collect data and track participants over extended periods of time.

The two companies announced their clinical trial recruitment service today in a request for proposal posted on the TrialSpark web site. The joint service is offered initially for mid-stage or “phase 2” clinical trial sponsors and study teams, that often test experimental treatments against a placebo with smaller randomized samples of human participants. The two companies are also inviting sponsors and study teams of post-marketing trials, sometimes called “phase 4” trials, after treatments are approved by FDA, that track long term efficacy and safety under real-world conditions.

Clinical trials can test experimental treatments in dermatology, gastroenterology, pulmonology, endocrinology, ophthalmology, inflammatory diseases, neurology, women’s health, and rare diseases. Cancer, gene, and cell therapies are excluded. In addition, the companies are giving priority to studies involving genomic testing, genetic-drug interactions, and results measured with digital technology, such as wearables. Only studies of participants age 18 and older, and taking place in the U.S. are being considered. The deadline for proposals is 15 November 2019, and up to three offers will be selected.

“With 23andMe we can empower even more patients to access clinical trials at their local doctor’s office,” says TrialSpark CEO Benjamine Liu in a company statement released through PR Newswire. “By using technology and a patient-first approach, we can run clinical trials with faster timelines and with operational consistency, ultimately bringing therapies to patients faster.”

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