Science 37 CEO and Co-Founder Noah Craft, MD, PhD submitted the following comments on the White House website’s Precision Medicine Initiative Page.
Fulfilling the promise of precision medicine will require unprecedented increases in the number and diversity of research participants. To ensure that this research benefits everyone, the diversity of participants must reflect the national population as a whole. Today’s standard means of recruiting, enrolling, and executing clinical trials must be fundamentally reimagined in order to serve this new phase of biomedical discovery. According to a 2013 Tufts Center for the Study of Drug Development report, 37 percent of all clinical trial sites fail to meet their enrollment targets, and more than 10 percent never enroll a single patient, despite the fact that close to 90% of patients are willing to consider participating in research.* The Clinical Trials Transformation Initiative found top barriers to recruitment include difficulty scheduling or securing transportation for study visits, and the demographics of research participants rarely match those of the population overall. These realities highlight the unmet need for people-centered innovation in the clinical trial research space, and for Science 37’s technology-enabled clinical trials management platform.
Science 37 is a Los Angeles-based clinical research company, and we are using technology to create the new clinical research methodologies necessary for precision medicine. The Science 37 approach disrupts the site-based model, replacing it with a faster moving, patient-centric solution. We bring trials to patients. We are developing systems to aggregate large numbers of micro-targeted patients efficiently, whether through EMR-based recruitment or by creating ‘metasites’ with broad geographic reach. Recruiting and engaging patients at home and in their local care system, and then bringing clinical trials to patients, has only recently become possible through new technologies and emerging market capabilities.
We bring trials to patients using our patient-centric mobile research platform, NORA® (Network Oriented Research Assistant). NORA® is a comprehensive, integrated, and customizable mobile data collection tool, trial-oriented EMR, and telemedicine platform that includes a mobile user interface for patient engagement, integration of home visits and mobile nurses, as well as a robust trial document and outcomes database. NORA® connects researchers directly to patients and their local care system; this connection enables seamless, HIPAA-compliant sharing of patient records and consultation, improving continuity of care for clinical trial patients. NORA® also facilitates real-time communication between participants and researchers, which we hypothesize will improve patient retention and data quality.
The Science 37 process and technology make clinical research faster, accelerate biomedical discovery, and reduce clinical trial costs. We’re currently partnering with both the pharmaceutical industry and academic research centers, and we anticipate many potential constituencies will use our platform for clinical trials, including precision medicine researchers. Because our technology and telemedicine-based systems allow us to recruit nationwide, we’re able to enroll more diverse patients by expanding beyond traditional university hospital patient populations. Using our services, researchers can find more patients, and patients can find the right trials. We were honored to have recently been recognized as the “Disruptive Innovation of the Year” at the 2015 DPharm: Disruptive Innovations to Advance Clinical Trials U.S. conference.
Science 37 is well-positioned to support the goals of the Precision Medicine Initiative. Our founders’ prior experience in clinical research, telemedicine, digital strategy, and healthcare software technology helped shape our approach. By combining this expertise with strategic partnerships with patient advocacy groups, clinical care facilities, technology companies and research institutes, we hope our platform will accelerate biomedical discovery and the ability to study and understand precision medicine treatment options. As the President highlighted in his State of the Union address, this kind of collaboration will be essential for the success of the Precision Medicine Initiative, and we are eager to be part of it.
Thank you for this opportunity to share our thoughts about how changing clinical research practices can lead to safe and effective customized precision medicine therapies.
Learn more: http://science37.com
*TUFTS CISCRP 2013 INTERNATIONAL SURVEY ON PUBLIC AND PATIENT ATTITUDES ABOUT, AND EXPERIENCES WITH, CLINICAL RESEARCH STUDIES