This was the message delivered by Belinda Tan, co-founder and co-CEO of digital health clinical research platform People Science, speaking at the recent South African Botanical Products Association (SABPA) Symposium (Feb. 5).
The adoption of digital health tools and decentralized clinical trial (DCT) methodologies exploded during the Covid-19 pandemic, she told delegates, leading to ‘exciting’ partnerships across tech, supplements and health firms, such as the recently reported Fullscript and Oura enterprise.
“DCTs are accelerating evidence generation and democratizing access. To me that’s super exciting,” Tan said, “importantly, it’s enhancing engagement of consumers involved in trials, reducing drop-out, and improving research quality.”
As well as lower drop-out rates than typically seen in site based methods, DCTs are time efficient, less costly, and less logistically complicated thanks to reduced staff requirements. In fact, Tan said studies which could cost around $2 million can be conducted at closer to $200,000.
She highlighted the supplements industry as a frontrunner in adopting new techniques.
“The earliest published RCT using decentralized clinical trial technologies was in the early 2000s when there was an academic study at Tufts where they looked at a dietary supplement in osteoarthritis patients. So this industry, compared to drugs, has that innovative spirit and I think that’s where the potential for change and growth can happen.”
Tech challenges
A common mistake in the conduct of decentralized clinical trials is the tendency to ‘cobble together off the shelf solutions’ such as the Google Suite tools, SurveyMonkey, Typeform, said Tan.
“Ultimately you run into walls because it’s not quite the appropriate implementation.”
“The main issues are lack of streamlined software and hardware, clunky apps and poor user experience. The participant user experience is the top priority; if you don’t concentrate on that you are going to get drop-out, poor quality data, and thus a poor-quality study.”
Some other key stumbling blocks can include shipping and sample collection logistics and poor accountability.
But with the right tools, study monitoring and documentation can all be automated to decrease overhead costs, Tan said. Data collection can immediately be streamlined with the use of high-quality mobile devices, such as Apple Watch, Oura ring or Garmen. However, she warned against the use of cheap or untested health tech which is unlikely to gather the same quality or detail on data.
She highlighted the importance of customized protocols developed with specific end-points in mind.
“What has been somewhat of a compromise with other DTC offerings in the marketplace is that everything is very fixed and templatized with no room for flexibility and I think that limits the questions you can ask.”
The CHLOE programme
People Science has developed CHLOE (Consumer Health Learning and Organizing Ecosystem), a software programme providing access to the backend dashboard allowing researchers to oversee studies and even message participants in real time.
She said the research is conducted via the CHLOE app which gathers data in a ‘gamified’ fashion to enhance engagement and allows the researchers to reach out to participants, or vice versa.
“That’s where all participant engagement happens and it’s a very powerful way for us to ensure a streamlined experience for participants. It allows them to remain engaged, minimizes dropout and maximizes data compliance.”
Verb Biotics utilized the platform to conduct two RCTs investigating it’s probiotic’s impact on sleep quality and anxiety.
The first six-week study utilized FitBits to collect data, and after the research sponsors saw the trial achieving ‘enough signals’ they invested in Oura rings for the second study in order to gain more in-depth data, said Tan.
People Science conducted participant outreach using social media ads which directed potential participants to a website with a pre-screening survey to determine qualification. Participants then received an email with a link to the CHLOE app.
“In the app they go into a further screening with additional questions, then the research staff can engage with them on the app. Those who pass the screening are randomized, supplies are shipped, and the participants continue with the study within the app,” she told delegates.
“In the first study we recruited, enrolled and randomized 122 participants within three weeks which is remarkable”, she said, adding that the sample was also of high quality as it included a diverse pool of participants.
What’s more, each study was conducted, submitted, and accepted by peer-reviewed journals within 12 months “so its an incredibly fast timeline”, said Tan.
