23andMe, the consumer genetics company, and TrialSpark, a technology company that helps physician practices 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 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.
The goal of the partnership is to assist in recruiting patients—one of the major bottlenecks that result in delays in bringing therapies to market. The companies note that, 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. This limits accessibility of trials for patients, reduces diversity of trial populations for sponsors and creates delays in trial development.
23andMe has a unique research platform, through which customers can choose to participate in research and fill out surveys about nongenetic 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.
This direct-to-consumer platform can help researchers target 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.
TrialSpark is a technology company that partners with doctors to create clinical trial sites within their existing practices and provides them with equipment, software and personnel support. 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.
“23andMe’s unique model solves for the biggest challenge in clinical trials—patient recruitment,” said Emily Drabant Conley, PhD, vice president or 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 communities.”
Priority review will be given for protocols submitted by November 15, 2019. Additional priority will be given to proposals that include the use of genomic testing, pharmacogenetic testing or digital endpoints (wearables, digital therapeutic combinations, etc.). For full details, visit www.trialspark.com/rfp.