After its venture arm helped raise $31 million for LA-based clinical research company Science 37 last October, Big Pharma Sanofi has now signed its first pact with the company aimed at improving recruitment and reducing trial times with new siteless study tech.
The pair plan to do this using modern technology and “decentralizing trials,” i.e., via the use of mobile phones and telemedicine services to help find patients for its trials regardless of geography and, importantly, keep them ongoing in tests—something that has been a systemic problem across the industry for years.
Sanofi said in a statement that “most people are eager to participate in relevant trials,” quoting a CISCRP study which found 87% of patients want to do so.
Yet, data show that around 70% of potential participants live more than two hours away from their nearest study center, something which hits recruitment and retention.
The ‘SanofiScience 37’ approach will allow patients to be monitored and report to researchers via an Apple iPhone (it did not say whether other providers, such as Android, would be part of this however) that are equipped with the company’s NORA technology (a.k.a. Network Oriented Research Assistant), its cloud-based mobile research platform.
“Qualified study participants are provided with the phone, a data plan and any other sensors or connected devices needed for the trial, along with the medicines being researched,” the partners explained.
“Participants can reach study staff at any time via the mobile device, while also remaining under the care of their local health care professionals.”
So-called “mobile nurses” are also sent to the participant’s home to provide services that can’t be done over the phone, such as blood draws, and nearby hospitals or clinics are also used for scans or other specialized services.
The patient’s data are sent to researchers who can then access information that would otherwise have to be collected face-to-face at study centers.
Using this type of tech can “reduce the time required for a typical trial by at least 30%,” according to figures from Science 37.
And the company add that, by eliminating months of searching for patients and travel time to study sites, “virtual clinical trials could reduce total trial time by as much as two years.”
Lionel Bascles, global head of clinical sciences and operations of Sanofi, said: “After years invested in the lab on an innovative treatment, the clinical trials are where we finally obtain and analyze the relevant data that will let us understand how well a new treatment will benefit patients.
“With digital clinical trials, we can get and analyze the data on how a new medicine works in the real world a lot sooner, which means patients get the medicines they need sooner.”
“Our decentralized clinical trial model addresses critical shortcomings of traditional clinical trials, such as enrolling and retaining appropriate patients. Whether you live near a major research institution, or in a remote area, we make participation possible,” added Noah Craft, CEO of Science 37.
“By utilizing a patient’s home in lieu of a physical trial site, we remove the burden of travel for those too sick or remote and provide access to qualified individuals who want to volunteer for a study but cannot because of geographic limitations.”