Sanofi launches a digital way to partake in clinical trials – to make participation more widely available and lower the duration of the trial itself. Clinical trials are a crucial step to putting the potentially life-saving medication on to shelves. However, due to the specifics required for each participant and their proximity to a research centre, 80 per cent of clinical trials are delayed due to recruitment problems in the US alone according to a study by the Centre of Information and Study on Clinical Research Participation (CISCRP).
Unfortunately, these delays prevent some of these innovative medicines from reaching its patient base or taking longer than necessary. Sanofi, partnering with Science 37 decided to tackle this problem head-on by taking a digital approach.
“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,” says Lionel Bascles, global head of clinical sciences and operations of Sanofi. “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.”
According to the study by CISCRP, 87 per cent of patients are willing participants for clinical studies, but yet 70 per cent of them live over two hours away from a research centre – deterring them. Many studies require the participant to check in a few times a week, which is too far for most people to attend during their busy lives.
Science 37’s approach allows patients to be monitored and report to researchers via an Apple iPhone equipped with the company’s NORA technology. Qualified study participants are provided with the phone, a data plan, any sensors or any devices needed to obtain the information for the study. With quick access to researchers, mobile nurses and under the care of local health care professionals, this could be a solution the geographical gap.
“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,” says 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.”
Sanofi’s agreement with Science 37 covers use of its Metasite model and NORA technology across the U.S. with plans to expand internationally in the future. By eliminating months of searching for patients and long travel time to study sites, virtual clinical trials could reduce total trial time by as much as two years.