May 9, 2016. SDCRN+SDRAN joint program
The Future of Clinical Trials. How Mobile Technologies and Telemedicine are Transforming Clinical Research
By Roberta Alexander, Ph.D.
San Diego Clinical Research Network (SDCRN) and San Diego Regulatory Affairs Network (SDRAN) came together to discuss ways to utilize telemedicine and mobile technologies in clinical research. The speakers were Kevin Bruhn, Ph.D., VP Strategic Development at Science 37, and Kim Tyrrell-Knott, Partner, Epstein, Becker & Green Law Firm. The event was moderated by Brad Pruitt, M.D., Executive Director and Chief Medical Officer, Parallel 6, and took place at BD (formerly Carefusion) in San Diego. Many members of SDCRN and SDRAN attended, in addition to others interested in clinical research and digital medicine.
Unlocking Access: How Mobile Technology Accelerates Discovery
Kevin Bruhn, VP, Strategic Development, Science 37
Science 37 was the winner of The Most Disruptive Innovation in Clinical Trials award by dPharm in 2015, and Clinical Informatics News Best Practices Award in 2016. Their CEO and Co-Founder, Noah Craft, M.D., Ph.D., was recently named as one of the top 40 healthcare transformers.
It is definitively an exciting time to use mobile technology in clinical research to reach more patients and keep them engaged. In fact, although 90% of patients say that they would like to participate in a clinical trial, only 3% actually do. Many patients live too far away from a site, don’t know that a study is even going on, or maybe they lack trust and education about clinical research. Patient recruitment suffers, and time and costs go up.
It takes 6 to 9 years to do the necessary trials to get a new drug approved, and clinical trials account for approximately 40% of the total budget of drug development. In addition, lengthy clinical studies leave less and less time for patent protection.
Science 37 aims to streamline clinical trials by decentralizing them and facilitating virtual interactions between the patient and the investigator. Science 37 uses a unique platform called NORA (Network Oriented Research Assistant) that functions as electronic medical record storage and database for data collection and management. Patients can interact with NORA via an app and stay engaged throughout the trial, without the inconvenience of traditional site visits. They can interact with the investigator and study coordinator via the app, have blood draws and other lab tests done at any local lab, and non-specialized assessments can be done by a local physician.
Science 37 acts as a metasite to coordinate protocol approval through a central IRB, patient recruitment, and study implementation via a network of local physicians and nurses and via the use of mobile devices that keep the patient at the center of the study. This set-up allows them to reach a greater number of patients in all geographical areas and of all racial backgrounds, increasing the enrollment of minorities in the study.
Science 37 was founded by Noah Craft in 2014, and has already collaborated with sponsors and CROs on several trials in various therapeutic areas. So far, their focus has been on oncology, dermatology, and rare diseases, where traditional patient recruitment is particularly slow. Science 37 has helped to accelerate studies and cut costs, and has established collaborations with various organizations, including Genentech, Harvard Clinical Research Institute, and Los Angeles Biomedical Research Institute, among others.
mHealth – Where Has it Been and Where is It Going?
Kim Tyrrell-Knott, Epstein, Becker & Green
Clinical research, either done in a traditional way, or done using modern technologies like those implemented by Science 37, is highly regulated. Good clinical practice, patient rights, privacy laws, rules by the department of Health & Human Services (HHS) and other federal or state laws, all regulate clinical research. From a digital health perspective, many changes are happening, and the FDA is taking a more liberal and risk-based approach.
Overall, certain aspects of digital health are still highly regulated, while others are not regulated at all. A good example of an unregulated technology is the FitBit: lots of people have one, and each collects lots of data, but how to use this data for a highly regulated process like a clinical study, if the device itself is not regulated at all?
Cybersecurity is also an issue with telemedicine for the FDA and other entities. The Food and Drug Administration Safety and Innovation Act (FDASIA) has drafted guidance for industry for the use of mobile medical applications. For example, clinical decision-support (CDS) software is more or less regulated based on the significance of the healthcare decision (e.g. diagnose vs. treat disease) and on the severity of the condition.
Overall, data acquired via telemedicine and mobile devices need to be regulated in ways similar to data acquired in more traditional ways, avoiding the risk of subjecting new technologies to higher standards.