23andMe and TrialSpark Announce Joint Clinical Trial Offering and Request For Proposals

- 23andMe and TrialSpark are collaborating on a reimagined clinical trial offering that is patient-centric and uniquely data-driven

- This offering will combine 23andMe's ability to contact engaged customers who have opted in to participate in research with TrialSpark's ability to create clinical sites with community doctors for faster, data-driven site selection, activation, patient recruitment and trial execution

News provided by

TrialSpark

Sep 26, 2019, 05:45 ET

NEW YORK, Sept. 26, 2019 /PRNewswire/ -- 23andMe, the leading consumer genetics company, and TrialSpark, a technology company enabling physician practices to become clinical trial sites, are announcing a joint clinical trial offering that combines the power of 23andMe's crowdsourced research platform and extensive database of consenting customers with TrialSpark's distributed site network and trial services.

To kick off this new offering, the two companies are also announcing a request for clinical trial proposals from sponsors interested in accelerating the pace, quality and experience of end-to-end Phase II or Phase IV clinical trials in the following therapeutic areas: dermatology, gastroenterology, pulmonology, endocrinology, ophthalmology, inflammatory diseases, neurology, women's health and rare diseases. Priority review will be given for protocols submitted by November 15, 2019. For full details, please visit www.trialspark.com/rfp.

Recruiting patients is one of the major bottlenecks that result in delays in bringing therapies to market, evidenced by nearly 48% of sites failing to meet their enrollment targets.¹ Traditionally, even if patients are identified, they often don't live near an existing trial site. Patients have to leave their doctor and travel long distances to participate.² This limits accessibility of trials for patients, reduces diversity of trial populations for sponsors and creates delays in trial development. 23andMe and TrialSpark are joining forces to create a modern clinical trial, designed specifically to address these bottlenecks.

23andMe is the only company with FDA-authorized direct-to-consumer Genetic Health Risk reports. 23andMe has a unique research platform, through which customers can choose to participate in research and fill out surveys about non-genetic information, like diseases they have, health and lifestyle. Combining non-genetic and genetic information can help improve the ability to identify genetic components of complex diseases. With 23andMe's commitment and emphasis on transparency, more than 80% of customers have opted-in to participate in research and over 60% have logged in to their account in the last 90 days.

23andMe's direct-to-consumer platform is uniquely positioned to disrupt the clinical trial recruitment status quo by targeting the right patients for the right trials at the right time. 23andMe is then able to contact appropriate, consented research participants in a personalized way to ensure enrollment actually takes place. Finally, 23andMe can leverage its re-contactable database to improve engagement and integrate the patient voice throughout the process.

"23andMe's unique model solves for the biggest challenge in clinical trials — patient recruitment," said Emily Drabant Conley, PhD, Vice President, Business Development, 23andMe. "It's game changing, because it is built around engaged customers who consent to participate in research, and it allows 23andMe to quickly find the right patients with the right conditions for clinical trials. Now with TrialSpark we are taking this one step further by enabling our customers access to clinical trial sites within their community."

TrialSpark is a technology company that runs clinical trials more efficiently by partnering with doctors to create clinical trial sites within their existing practices and providing them with equipment, software and personnel support. TrialSpark's approach removes variability in operations at the site level by using a single technology platform, which cuts out the manual, time-intensive and costly tasks that delay clinical trial timelines. With more sites in more locations, TrialSpark makes trials more accessible to patients and unlocks new patient pools who have never been exposed to trials, which boosts enrollment rates, retention rates and diversity of patient participants. Because of TrialSpark's flexible operating model, additional data and endpoints can be captured via wearable technology, digital therapeutics, or at-home genetic testing with 23andMe.

"TrialSpark has already made significant efforts toward expanding access to clinical trials by creating sites where patients live and with doctors they already see. With 23andMe we can empower even more patients to access clinical trials at their local doctor's office," said Benjamine Liu, CEO and co-founder of TrialSpark. "This collaboration with 23andMe is a major step toward redefining modern clinical trials and accelerating the pace of medical discoveries. 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."

23andMe and TrialSpark are excited to present this opportunity to sponsors. This request for proposals from 23andMe and TrialSpark is targeted toward forward-thinking life science companies conducting Phase II or Phase IV clinical trials.

For full details of this joint trial offering as well as examples of potential protocols that would be suitable for this offering, please visit www.trialspark.com/rfp. For consideration, please send any ideas for potential trials with written protocols if available. Additional priority will be given to proposals that include the use of genomic testing, pharmacogenetic testing, or digital endpoints (wearables, digital therapeutic combinations, etc.).

About TrialSpark
TrialSpark's mission is to bring treatments to patients faster and more efficiently by reimagining the clinical trial process. TrialSpark has scaled a network of trial sites by partnering with doctors to create clinical trial sites within their existing practices. TrialSpark runs trials out of these doctors' practices using a roaming cohort of clinical research coordinators, optimized by software, data and technology. Without variability in operations at the trial site level, TrialSpark cuts out the manual, time intensive and costly tasks that delay clinical trial timelines. By creating trial sites with doctors, TrialSpark unlocks the 98% of patients who have never been exposed to trials, boosting recruitment and enrollment rates and democratizing access.

About 23andMe
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand and benefit from the human genome. The company was named by TIME as a "Genius Company" in 2018, and featured as Fast Company's #2 Most Innovative Health Company in 2018. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. More information is available at www.23andMe.com.

References:

^1.	Impact report: Analysis and insights into critical drug development issues. Tufts Center for the Study of Drug Development. 2013;15(1)
^2.	Borno HT, Zhang L, Siegel A, et al. At what cost to clinical trial enrollment? A retrospective study of patient travel burden in cancer clinical trials. Oncologist. 2018 Oct;23(10):1242-1249.