I first became aware of 23andMe’s entry into the clinical space while reading an online article about GlaxoSmithKline’s (GSK’s) $300 million investment in the genomics company. The article did not spin the news in a positive light. It noted the investment has given rise to privacy concerns, but didn’t mention any specific scenarios. It did quote Peter Pitts, president of the Center for Medicine in the Public Interest, saying patients should be concerned about their genetic information being misused, which seems to be stating a general, if obvious, concern of this digital age. It’s not even clear that the statement from Pitts was referring to the GSK investment, which was not mentioned. At one point, the article even refers to the news as “scary.”
But how does the news really impact the millions of customers of the genomics company? In a nutshell, not much. Since the company launched its DNA testing service in 2007, approximately 80 percent of its customers have consented to having their data used for research. Which, coincidentally, is exactly what GSK and 23andMe will be doing with the information. That being the case, the GSK announcement should not have come as a surprise to anyone. Insights gained from consented customer data has been shared with at least six other pharma and biotech firms in the past three years. However, this is only de-identified, aggregate-level summary statistics. No individual-level data is shared. Additionally, an article in WIRED from November 2007 noted that was always a part of 23andMe’s business plan. From the very start, 23andMe has believed it could help bring patients to trials and cures to patients.
The Search For Cures Starts With Good Data
Developing cures for many diseases will require research into genetic data of the type 23andMe is collecting. The company is also collecting user information via voluntary surveys, asking users several questions every time they log on. The company now has, on average, over 350 data points (which 23andMe calls phenotypic information) on each customer. With the information it now has, 23andMe is confident it can deliver on its goal of outperforming the traditional medical research model in speeding cures to patients.
To conduct clinical trials, pharma must first find patients to participate in the research. This is an area where 23andMe may make its greatest contribution to research. The patient recruitment problem, as well as its consequences, are well known to everyone in clinical research. A small number of patients (currently around five percent) actually participate in clinical trials. Many patients do not know that trials exist, physicians seldom recommend them, and trials are often delayed or cancelled as a result of poor patient recruitment.
23andMe believes their mission on the clinical side is to empower their customers to take control of their health data and gain access to innovative therapeutics through clinical trials. Other companies are attempting to do something similar. But, 23andMe’s main differentiator is that it has a platform that allows for direct consumer connections and engagements. The company has sold over 10 million kits, and 60 percent of clients have used its platform in the last 90 days. Not only have these clients opted-in to participating in research, they also answer survey questions. If a trial seems to be a good fit for them, they must consent to wanting to learn more about the trial, and will also consent to having the trial site contact them. Only then will the site initiate contact.
“We have over 2 billion survey questions that have been answered by our clients, and roughly a million and a half new health data points are collected daily,” says Shawn Tedman, director of clinical trials for 23andMe. “We have actively engaged customers on the platform and they are providing us with meaningful and interesting health data in addition to genetics. That seems to fly a bit under the radar. People know us for the direct consumer genetics piece, but users of the platform provide us with an average of over 350 additional health data points.”
Those additional data points include things like the individual's self-reported health conditions, severity of their disease, and medications they are taking. Questions are tailored by disease state. Initially, clients will get general questions about their health and what diseases they might have. Then the questions become more condition-specific. For example, if the individual has a metabolic condition, the survey could inquire about type II diabetes or other related conditions. Condition-specific questions have been developed with industry stakeholders and 23andMe now has a database of over 35,000 questions that can be shared with users. Information gathered from patients is updated regularly. This has allowed the company to gather a wealth of data on certain diseases.
Engagement is a term that Tedman uses often. One goal of 23andMe is to drive engagement with users of the platform. A byproduct of that engagement is that customer information is always fresh and current. Tedman does not believe enough has been done to engage patients and educate them on clinical trial participation generally, and that is something 23andMe is hoping to change.
Build Clinical Trial Awareness
Educating users on clinical trial availability is a task that 23andMe is well-equipped to address. Interactions occur via a consumer platform. Survey questions specifically related to clinical trials ask users if they would like to learn more. Users who are not initially interested in a trial can have a change of heart once they learn more about the trial process. Tedman believes the company will definitely impact the percentage of patients who opt to participate in trials.
“We believe we are empowering our users to do things that will help them become healthier individuals,” says Tedman. “What we hope to learn will be a win for the entire life sciences industry, and the value goes both ways. We can learn from what other organizations have done and incorporate those learnings into our processes. We will also be sharing our learnings with the rest of the industry.”
If a pharma company wants to collaborate with 23andMe, the first step is to define objectives. Although 23andMe has a focus on trial recruitment, it is also looking at ways to improve protocols, site selection, trial feasibility, and making trials more patient-centric.
“We will talk to that potential collaborator to discuss their goals and assess its fit with our dataset and customer base,” states Tedman. “We can give them an idea of how many clients we have with certain conditions. For example, we have over a million customers with a self-reported diagnosis of depression. Over 50,000 have self-reported a diagnosis of epilepsy. From there, we assess their goals to determine what they are trying to do, and whether it aligns with our patient-centric and customer-centric outlook. The bottom line for us is we always want to make sure we’re empowering customers and doing things that are patient-centric.”
If the goals of the collaborator align with the goals of 23andMe, customers will be engaged (by 23andMe) to determine their interest in a trial and to gather feedback on potential protocols. As noted earlier, customers must consent to receiving information on the trial and to be contacted by the trial site. 23andMe will only request that consent if it determines the customer is a fit for the trial. The site will then contact the patient to begin the screening and enrollment process. Even at that point no genetic information is shared. The site will only receive contact information (name, address, phone number, and email) on the patient to facilitate additional screening. The patient still has the opportunity to opt-out of the screening process at any time.
Patient Follow-Up Is Important
A common complaint from patients, investigators, and sites is that they participate in a clinical trial but never hear about the outcome of the study. That is another pain point 23andMe is trying to alleviate. Patient-centricity is important to the company not just before and during a trial, but afterwards as well. 23andMe views itself as a trusted third-party with a trusted brand and platform. Tedman believes that allows the company to gather honest feedback on a trial, the drug, and the sponsor company. He also believes it would be difficult for any site or sponsor company to gather feedback with that same level of impartiality.
“We are a third-party unaffiliated with the site or the trial,” notes Tedman. “Therefore, we are a neutral party requesting feedback. We are also doing it through the trusted lens of a partner platform that the patients are already familiar with. The platform allows us to interact with the patient during the trial, provides resources to them, and provides reminders about their study visits.”
Eventually, 23andMe hopes to provide trial results directly to their customers in a way that pharma companies do not. Tedman states some pharma companies have tried producing lay-language summaries of trial results and sending them to sites, which are then supposed to send them to patients. Unfortunately, that rarely happens. Pharma and the investigator sites have simply not found an easy way to perform the task. According to Tedman, it is not due to a lack of focus or interest.
“Direct-to-consumer communication is something that pharma companies just don’t have a lot of experience with,” he adds. “It is something you really have to build out and develop over time. That is something we have done. There is a page within our platform that will tell a customer how many studies they have participated in along with a link to updates or results for each one. We were already doing something similar for academic research collaborations, so it was easy for us to put that same focus on clinical trial results. Our lay-language summaries inform patients of what happened with the trial and where it will go from here.”