23andMe and TrialSpark seek to reimagine a clinical trial—from a top-down, expensive and time-consuming reality, often run by intermediary contract research organizations (CROs) to one that is a data-driven, patient-centric and more agile in nature. By combining 23andMe’s ability to engage their DNA genetic test consumer base with TrialSpark’s ability to identify clinical sites with community doctors, the hope is that a new kind of clinical trial will emerge: a more dynamic, patient-responsive, and data-driven study with streamlined site selection, activation and execution.
TrialSpark, a technology company seeking to enable physician practices to convert to clinical investigator sites, was reviewed by TrialSiteNews with some optimism but with a critical eye. They seek to leverage 23andMe’s crowdsourced research platform, including extensive DNA consumer database, consisting of “consenting potential study subjects” with TrialSpark’s distributed site network and trial services.
An RFP for BioPharma Sponsors
The pair seek to turn clinical research upside down, and the timing is good. The current clinical trial model struggles, and by all accounts and measures, clinical research is an industry ripe for disruption. Hence, the two new kids on the block plan on issuing a request for proposal to industry sponsors keen on accelerating the pace, improving the quality and enhancing the 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 will give priority review to protocols submitted by November 15, 2019-see the link for details.
The Standard Critique
In the TrialSpark issued press release, the two vendors go on to remind the reader of the standard clinical trials challenges, such as the major bottlenecks resulting in delays in bringing therapies to market, evidenced by nearly 48% of sites failing to meet their enrollment targets. They note to the reader that site-driven trials don’t consider the patient’s situation, causing lack of patient participation (e.g. trials are far from a patient’s home, etc.). We couldn’t agree more.
Because 23andMe is the only company with FDA-authorized direct-to-consumer Genetic Health Risk reports, they have developed what has emerged, they position, as a unique research platform—one in which consumers can choose to participate in research combining both genetic and non-genetic information which can help improve the ability to identify genetic components of complex diseases. More than 80% of 23andMe consumers have opted-in to participate in research, and they report over 60% have logged in to their account in the last 3 months. It is because of this vast pool of willing consumers who have openly shared their health information, allowing them to slice and dice the data, search and pin point the right prospective patient for the right clinical trial at the right time. With the right patient engagement the follow up experience can make patient recruitment much easier and faster goes the premise.
Emily Drabant Conley, PhD, Vice President Business Development 23andMe, emphasizes about the partnership that “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 trial. Now with TrialSpark we are taking this one step further by enabling our customers access to clinical trial sites within their community.”
Now, this is combined with the TrialSpark offering, which essentially seeks to build a network of physician practices that are converted to trial sites thanks to the TrialSpark technology platform and associated site services that we described as part of their offering back in December of 2018.
Emerging as a Virtual CRO?
TrialSpark has raised about $70 million according to Pitchbook and now employs nearly 200 from what we can estimate. They are hiring more quality assurance, clinical research associates (monitors) and related personnel leading us to believe that they are emerging as a new form of digital CRO as we predicted in our initial assessment back in late 2018. They have the added benefit of designing the company and approach, from the ground up, to leverage technology and data-first and incorporate the community physician practice model to attempt to address a fundamental challenge in the industry—that only about 5% or less of all physicians are active clinical investigators. In fact, most clinical investigators fall in the category of “one and done” in that they try participating in a clinical trial one time but find it too onerous and difficult for the trouble. Pharma sponsors don’t make it easy in all reality with often onerous payment terms to mention one example.
The Novartis Deal: Is it Working?
TrialSpark inked a deal with Novartis back in December 2018 where the Swiss drug makers sought to leverage the new, patient-centric model to access new clinical trial sites in the New York City area to test a treatment for ankylosing spondylitis.
Performance Question: since the inking of this deal, has Novartis seen noticeable performance at the new sites supplied by TrialSpark? Has site activation and study start up actually accelerated because of the bringing together of new community based sites via the new digital intermediary, TrialSpark, with patients in the community? What has been the patient-enrollment rates at the New York sites compared to others? TrialSpark serves as a new intermediary at least for this pilot or focus area in New York City. TrialSpark supplies the required labor power (e.g. monitors for the sponsor side and coordinators for the site side) and technology (e.g. GcP-compliant, end-to-end technology platform including precision-targeted recruitment, algorithmically-prioritized trials, risk-based quality monitoring and cloud-based CTMS/eSource data capture. This is a big burden to bear—and ultimately very costly.
Results are What Matter to Biopharma Sponsors
There is no doubt that 23andMe and TrialSpark are working to shake up the clinical trials industry. By leveraging a vast pool of consenting patients and enabling infrastructure a different model may emerge that very well could prove beneficial to industry sponsors who seek to accelerate site activation, study start up cycle times and patient recruitment rates; not to mention tap into and leverage patients and physicians presently not easily accessible. By bringing together patients and their community physicians with the right targeted clinical trials both 23andMe and TrialSpark can not only help industry but also in some cases actually save lives. This is a big deal.
But this not an easy industry to change and a number of fundamental assumptions underly the success of the exciting partnership. First and foremost the level of trust in big biophama is not high among vast numbers of consumers. Just because people have opted int to a DNA test for example, doesn’t mean that they trust big medicine and big pharma. Although the TrialSpark enablement of community physician practices seemingly may help to establish a gateway to greater patient trust, conducting clinical trials is a highly complex, specialized and regulated affair. For example, for all the talk of remote and risk-based monitoring by industry we are still a long ways away from departing from traditional monitoring needs. The recent updates in ICH E6(R2) and associated risk-based approaches lead to reports by sites of burdensome and onerous “over monitoring”.
Moreover, as TrialSpark must serve as an intermediary between sponsor and site, it requires lots of specialized skills that CROs typically offer—making TrialSpark emerge as a form of technology-driven CRO as we suggested in our first coverage of the startup. In fact, the TrialPark model may be even more expensive as they must somehow handle the infrastructure for the site as well. Why? Because they tout many sites they bring on board are traditional physician offices and community health centers which don’t possess the skills, knowledge and infrastructure to conduct clinical research. This means that labor costs will increase driving them to the need to structure and negotiate large CRO-type deals with industry sponsors to ensure a path to breakeven and profitability. That necessitates a certain kind of business culture that may at some point conflict with the need for careful cultivation of community engagement ultimately required for greater patient trust.
Call to Action: Sponsors should submit protocols to TrialSpark and assess the capabilities and perhaps conduct a pilot trial—establish standard KPIs for site activation and study start up to compare and contract against CRO-managed studies.