Without clinical trials, new medicine may never make it from the research lab to patients in need. These carefully designed studies can provide important data that include proper dosage, benefit to patients, and potential side effects.
There is a growing challenge, however, in finding appropriate participants, especially for treatments that target highly specific conditions affecting narrower patient populations. Right now, there are more than 40,000 clinical studies recruiting patients in the U.S. alone, with some requiring thousands of participants, each of whom must meet precise criteria to join. So it’s not surprising that 80% of these important studies are delayed due to recruitment problems, according to a study by the Center for Information and Study on Clinical Research Participation (CISCRP).
Unfortunately, those delays mean it can take longer for innovative new medicines to be studied and approved, leaving patients to wait years for new treatment options. To tackle this growing problem, Sanofi is taking a digital approach to clinical trials, partnering with Science 37,a clinical research services and technology company based in California.
Leveraging mobile technology and telemedicine capabilities, this new approach will allow Sanofi to develop “site-less” or decentralized clinical trials that are more patient friendly: easier for them to access, and eliminating many of the common impediments to participation. Using digital technologies to streamline finding and retaining participants for the entire length of a study has the potential to reduce the time required for a typical trial by at least 30%, according Science 37.
Going digital also eliminates a number of other hurdles to patient participation, including the most significant: geography.
Most people are eager to participate in relevant trials – 87% of patients want to do so, the CISCRP study found. Yet, 70% of potential participants live more than two hours away from the nearest study center. Because most clinical trials require patients to travel to those centers for regular tests and observations, sometimes several times each week for the duration of the trial, this distance is another challenge to patient access.
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 and any other sensors or connected devices needed for the trial, along with the medicines being researched. Participants can reach study staff at any time via the mobile device, while also remaining under the care of their local health care professionals. Mobile nurses are also sent to the participant’s home to provide services like blood draws when needed, and nearby hospitals or clinics are engaged bfor scans or other tests that require specialized equipment.
The patient’s data are sent securely to researchers who can immediately access information that would otherwise have to be collected by medical personnel through face-to-face interactions at study centers. This platform can also remind patients to take their study medications at the proper time, and let researchers know if participants are adhering to the study requirements.