People Science brings “science to the people” with decentralized clinical trials

Decentralized clinical trials offer time and cost savings as participants join a trial from home instead of a research center. In addition, US-based People Science says that its innovative clinical trials allow more people to participate and ask questions, aiming to “democratize science” with its tools.

Through the company’s mobile app, Chloe, nutraceutical companies can conduct rigorous clinical trials more affordably. Trial participants receive a product and testing equipment at home, and track their progress through Chloe.

Nutrition Insight continues its conversation with Noah Craft, the co-founder and co-CEO of People Science. Craft and the company’s other co-founder, Belinda Tan, have a Ph.D. and MD background as physicians, microbiologists, and immunologists. 

“We have a fundamental mission at our company to bring the tools of science to the people; our company’s name is that for a reason,” says Craft. “Because of how the platform is built and how affordable it is, many more people can ask rigorous, scientific questions.” 

To enable this, the company allows more people to ask questions, ensuring that everybody’s voice and data can be heard. Craft adds: “Because Chloe should be accessible to most people with a smartphone, it means you can participate.” 

“Similar to voting, go vote if you want your voice to be heard. If you want your scientific voice to be heard, participate,” he underscores. In addition, some of People Science’s clients speak on behalf of a community of people. 

Pharma to nutraceuticals

Pharmaceutical companies are increasingly exploring nutraceuticals, as we explored with several suppliers at last year’s CPHI trade show in Milan, Italy. 

Similarly, Craft and Tan switched from a company focused on clinical drug development to creating a platform that supports nutraceutical companies. Although Craft says this company still serves the pharmaceutical industry, both co-founders thought “it was time for rigorous science, scaled, decentralized work” to come to the nutraceutical space. 

“When we started People Science, we felt like there are so many solutions to human health and wellness that are affordable, sustainable, accessible, and many have been used for millennia,” he explains. 

Craft says there are many preventative human health solutions that are affordable, sustainable, and accessible, with a long history of use.“Some plants have been known to be beneficial for thousands of years. We wanted to bring the lens of rigorous science to this space to bring more affordable, sustainable products into preventative health, wellness, and betterment.” 

In contrast, he notes that the pharmaceutical space focuses chiefly on late-stage diseases and single molecules, which are very expensive to develop and are very expensive. “That system waits for disease to become severe before you treat it.” 

Focus on quality control

Craft notes that in pharmaceutical trials, decentralized or virtual work is commonplace. He highlights: “They don’t even talk about where the data is collected.” 

In the pharmaceutical sector, data quality and how it gets into the system is regulated and more important than where data is collected. 

However, decentralized trials are new among nutraceutical companies, as most research is still done traditionally with “someone sitting in a lab.” 

Craft explains that such control doesn’t necessarily lead to better-quality data. For example, in pharmaceutical trials taking place in a research center, participants can still smuggle in candy bars, or “if you only see them once a month, they dump out the bottle of pills before they walk in the door and say, ‘I took them all.’” 

“If you want to know how your product performs in someone’s real life, then study them in their home and build trust. We often encourage people to tell us the truth. Every day we ask you, ‘did you take it?’” 

People Science used its experience in pharmaceuticals to develop a secure mobile app to enable rigorous decentralized trials.If participants take 27 out of 30 pills a month, the researchers can skip the data points for those three days they didn’t take one. 

“With the combination of trust and meeting people where they are at home, you have better quality data,” says Craft. “You’re accepting that you can’t see everything that goes in their mouth, but you can ask them to tell you everything that went in their mouth.”

In addition, Chloe is built to US FDA and European Medicines Agency audit specifications. Craft says that every piece of code and data has an audit trail. 

“You have to believe it [the data] came directly from a specific person and has never been changed. If someone opens and changes it, you have to give a reason for why you opened it. It’s quite an intense, high-quality system from a regulatory perspective.” 

Built on trust

Trust is imperative in People Science, says Craft. “If consumers don’t trust us, it’s over.” 

He explains that the company’s app is built to the highest privacy and personal security specifications, making it challenging to hack into. Moreover, consumers own and control their data. 

Chloe helps nutraceutical companies to assess how their product performs in someone’s real life, instead of in a research center.“The consumer or the participant controls all the sharing,” Craft adds. “You can use Chloe without sharing at all. If you join a sponsored study, you have to share it with People Science and the sponsor, but you own your data in perpetuity.” 

“We maintain your data for you, and then you own it, but you have the right to cancel your account and withdraw your data — it’s yours.” 

Although that is standard practice in Europe, he says that is not true in the US. “Some states are progressive about who owns the data, but it is very different from doctor-owned or pharmaceutical company-owned data.” 

In addition, People Science ensures that the data has value for app users in terms of presenting data conveniently. “There are a lot of visualizations of your data. At the end of these studies, we send the participants the study data so they can see how they compare to other people,” says Craft. 

He says that because all study results are shared with participants, People Science’s clients also need a degree of faith in their product, as it may not work for everyone. 

“Our clients are science forward, clients that don’t care about science, they don’t hire us,” he notes. “It says a lot about our clients — they care to know if things work.”