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TrialSpark taps community clinics, doctors to increase clinical trial diversity

➤ TrialSpark is a healthcare technology startup leveraging algorithms and data to speed up and expand clinical trial recruitment into U.S. regions that typically do not host such research.

➤ New York-based TrialSpark partners with research institutions and pharma and biotech companies on clinical trials for the skin condition vitiligo, gastrointestinal diseases, respiratory conditions, central nervous system disorders and primary care conditions.

➤ TrialSpark announced a collaboration with consumer genomics company 23andMe Inc. in September 2019 to apply both companies' technology to select clinical trials.

Benjamine Liu is the CEO and co-founder of TrialSpark.

This interview has been condensed for clarity.

S&P Global Market Intelligence: How do you determine sites for partnered clinical trial programs, and what are the logistics of getting community clinics set up?

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TrialSpark CEO and co-founder Benjamine Liu.
Source: TrialSpark

Benjamine Liu: There's a big site shortage: We need 5 to 7 million doctors to fill up all the trials on, but there's really only on the scale of tens of thousands of active sites or doctors consistently involved in clinical trials.

TrialSpark has access to maybe a billion diagnosis code data that are deidentified but traceable to a National Provider Identifier number or a sufficient identifier, so we can map the eligibility and ineligibility criteria around patients to the doctor who sees those patients. We have a team that contacts those doctors, and we provide all the training and equipment for them to create a trial site. We provide them with full-time research coordinators (who are full-time team members of TrialSpark) who can be their point of contact and also the study coordinator or research nurse.

What kind of outreach does TrialSpark conduct to raise awareness among doctors and patients?

Part of that process is when we call the doctor, we educate and share information on their opportunity to participate. Given that most doctors go through medical training at an academic institution, sometimes the trade off is, if you leave academia you can no longer contribute to research. That's a big driver, and crucially, being able to offer their patients access to medicines they might not otherwise be able to. We've seen the doctor uptake to be a lot higher than we initially expected. Almost every single doctor we've worked with has signed up to do a second trial with us.

At the sites we partnered with, a lot of the support we create with our physician partners is awareness campaigns around their communities, that now there's a place where you can access clinical trials. Given the communities we serve, we can also increase the diversity of patients and doctors reached.

Where are your community sites?

We operate in Brooklyn, Manhattan, the Bronx and Long Island in New York; New Jersey; Chicago; Washington, D.C.; Philadelphia; and Houston and Dallas in Texas. Out of the patients who have visited our Bronx and Brooklyn sites, 50% are nonwhite or non-Caucasian, non-Hispanic; 30% have been African American; 10% have been Asian. Out of the 50% white, Caucasian and/or Hispanic, 30% have been Hispanic.

One of the surprising things we encountered was, we were supporting a program for a large pharma company and we were the first site to request Spanish translation for some of the materials. As a consequence of creating trial sites where the patients are, and doctors who really reflect the community they serve, we've been able to reach a lot more diverse patients. Most sites we create are outside the major hot spots of where traditional clinical research is done. And not asking patients to leave the doctors they see to participate in trials is another big value driver.

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Are wearables and sensors being used in TrialSpark's trials?

One of the advantages of our platform is it's very easy to integrate some of these novel wearables. We're looking at upcoming atopic dermatitis (eczema) studies and interesting wearables for itch, or proxies of how a person itches or scratches an itch. For Parkinson's, certain things measure tremor or gait better than a subjective scale. We've increasingly seen interest around the industry, but the groups running the trials aren't tech companies themselves. As a tech company, the data capture platforms we've built are easily integrated with these modern tools.

What motivated the partnership with 23andMe?

23andMe has the ability to, through their direct community base, understand where very specific patients are, and have deep phenotype and genotype information. If 23andMe knows where the patient is, and we know the doctor who sees this patient, we can just create a trial site near that patient. And that also enables genotyping-based studies that traditionally would be very difficult. So if you need to run an Alzheimer's study targeting patients with the ApoE4 homozygous or heterozygous genotype, that would be hard to do. But if you can start with where the patients are, and create this trial site where they live, that's a really powerful combination.

One of the things we're really excited about is, if you can run trials faster and more efficiently, ultimately bringing down the cost of drug development can also expand access to new medicines and hopefully bend the cost curve on drug pricing as well.