CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trial space. Staff Writer Ron Rosenberg spoke to Noah Craft, M.D., Ph.D., co-founder of Los Angeles-based Science 37, which seeks to transform biomedical discovery and reduce clinical trial costs using a mobile research platform to simplify the process of participating in clinical studies.

Q: Bringing end-to-end clinical trials to par­ticipants’ homes using an array of medical services that includes mobile nursing companies, pharmacy chains, patient advocacy groups and rapid prototyping is your com­pany’s new tool to accelerate drug development. How will it work in replacing traditional clinical trials and overcoming new cost concerns?

A: Science 37’s end-to-end clinical trials metasite op­erating model uses digital recruitment strategies, locally delivered medical services and our NORA (Network Oriented Research Assistant) mobile technology platform to bring clinical trials di­rectly to patients, in their home and within their local care circle. The traditional clinical research model is built around the academic research center, which limits the number of people who can participate to those who live close by, exclud­ing up to 70% of potential participants. The tra­ditional site-based model is incredibly expensive and, with so many sites underperforming on recruitment goals, the lengthy time required to complete trials is a growing challenge.

The NORA mobile technology platform sup­ports the Science 37 metasite operating model. NORA’s core functions include online consent, a trial-specific EMR, a telemedicine platform, and a mobile data collection tool. On the front end of NORA is our easy-to-use mobile applica­tion, which enables seamless communication throughout a trial and connects patients, mobile nurses, and their local doctors to the Science 37 metasite staff and researchers.

Using this platform, we are able to enroll patients from anywhere in the U.S. much more quickly than traditional trials can. More importantly, the patients participating in our trials have an extremely high satisfaction rate and have 24/7 access to the clinical research team through NORA.

The pharmaceutical and medical device industries spend approximately $50 billion an­nually on clinical trials. Because of the significant efficiencies that the Science 37 operating model and our metasites create, we are able to provide faster end-to-end clinical trial services to spon­sors and researchers, while operating at a lower cost than traditional models. When it costs about $1 million a month just to keep the average clini­cal trial open, increasing the speed of trial imple­mentation has significant financial benefits.

Q: NORA puts the trial directly in patients’ hands so participants are better engaged with researchers and their staff. What are some of the patient-centric concerns/problems you hope to resolve through technology that can’t be done today?

A: Despite having instantaneous connection to almost every other aspect of daily life, patients lack real-time information about and access to clinical trials. More than 80% of patients say they are interested in participating in trials— but according to a Clinical Trials Transformation Initiative report, among the top barriers to clinical trial recruitment are patient mistrust of research (45.6 %), transportation to study visits (45%) and difficulty scheduling study visits (40.5%).

Our NORA platform utilizes telemedicine and coordinates mobile workforces to over­come geographic barriers and unlock access, so anyone can take part in trials, including rural, underserved and minority populations, and people with significant mobility challenges. By creating a telemedicine-based platform, through which patients can connect with the care team and resources they need 24/7, we are increasing patient satisfaction and retention while ensuring better collection of high-quality, real-world data and improving safety monitoring.

Q: You won the “Disruptive Innovator of the Year” award at the Disruptive Innovations to Advance Clinical Trials conference in Septem­ber and are taking part in the first phase III, FDA-registered clinical trial with a major pharmaceutical company. Looking ahead, how and when do you envision indus­try acceptance of trials that deliver end-to-end services to patients at home and in local circles?

A: Highly regulated industries are quick to default to the conventional approach. To increase acceptance of our model, Science 37 is demonstrating we can deliver clinical trials with the highest safety and data-quality standards, but with added convenience, efficiencies and patient satisfaction. By starting with the question “What’s best for patients?”, we are creating a way for more people to take part in research.

The good news is that we’re already demon­strating success in multiple studies with major sponsors in prototyping and registration trials. Our plan is to move forward with new research across therapeutic areas, continue to validate our model and generate more effectiveness data.

Science 37 is past the proof-of-concept stage and we are expanding our core team and offer­ings. We plan to work with the most innovative sponsors and in disease areas where our work is most impactful. The industry has been asking for the “decentralized clinical trial” model for some time. So we’re looking forward to widespread acceptance of our new operating model.

This article was reprinted from Volume 19, Issue 48, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »