January 10th, 2018 Clinical Trial Technology Will Continue to Evolve In 2018 What will clinical trial tech bring in 2018? Here are some of our predictions. In the past year, we’ve seen a number of exciting improvements in clinical trial technology, from remote patient monitoring to mHealth initiatives to digital patient recruitment tactics. It follows that we’ll continue to see improvement on this front in 2018, with new technology and regulations enabling better engagement, higher patient retention, and lower costs. Here’s what we predict that 2018 will bring for clinical trial technology. A Stronger Foundation for Digital Health Announcements from the FDA have already ensured that 2018 will be a momentous year for digital health. The agency recently updated the 21st Century Cures Act to create special categorizations for software functions in medical technology, giving them the flexibility to regulate complex products with multiple functions. The FDA has already applied this kind of logic to computer-aided diagnostic tools, which qualify for fast-tracked approval so long as the tools are comparable to those already on the market. This change not only makes it easier to build certain digital health technologies, but also sends a message to developers that the FDA supports the use and approval of this kind of tech in clinical trials. As such, certain sponsors and CROs like Novartis have already begun to use digital health tech to improve medication adherence and therapeutic support. Though the FDA has yet to announce specific guidelines for regulating digital health technology in clinical trials, the company has worked with the Duke-Margolis Center for Health Policy to release a set of best practices for the use and development of mHealth tech in this setting. In 2018, we’ll see even more digital health tools make their way into clinical trials. These technologies – like compliance apps, data capture tools, and remote trial delivery systems – will support sponsors and CROs as they work to improve patient retention and reduce costs. A Renewed Focus on Patient Centricity In 2018, the industry trend toward patient centricity will continue to grow. The industry already recognizes the value that patient centricity can provide; in a recent survey, 79% of respondents reported the belief that patient centricity is a meaningful initiative for clinical trials to pursue. In the coming year, trials will continue to incorporate patient centricity initiatives and improve patient feedback pipelines so they can increase rates of recruitment and retention. This coming year, clinical trials will continue to integrate the patient perspective into trial design and invest in technologies that streamline the patient experience. Sponsors and CROs will explore remote trials, telehealth, and digital health monitoring technologies to reduce site visits and improve follow-up. Other practices include partnering with ridesharing services to meet patients’ transportation needs and using centralized digital portals where patients can access trial information from the comfort of their homes. Employing the right kinds of patient centricity initiatives now will reduce costs of drug development in the long term. Better Analytics and Risk Management Software We also predict that 2018 will bring higher-quality analytics models to the clinical trial industry. These technologies can help sponsors and CROs improve the quality of trial practice and oversee vendors more effectively. Pfizer has already begun using a customized analytics platform to establish program- and study-specific key performance indicators (KPIs) and track progress toward those goals over time. Data visualization and tech integration across platforms should also improve across the board. Though widespread implementation of many of these technologies is still a long way off, 2018 will bring us closer than ever to streamlined, tech-enabled clinical trials. We’re looking forward to seeing how far the industry can go.
What will clinical trial tech bring in 2018? Here are some of our predictions. In the past year, we’ve seen a number of exciting improvements in clinical trial technology, from remote patient monitoring to mHealth initiatives to digital patient recruitment tactics. It follows that we’ll continue to see improvement on this front in 2018, with new technology and regulations enabling better engagement, higher patient retention, and lower costs. Here’s what we predict that 2018 will bring for clinical trial technology. A Stronger Foundation for Digital Health Announcements from the FDA have already ensured that 2018 will be a momentous year for digital health. The agency recently updated the 21st Century Cures Act to create special categorizations for software functions in medical technology, giving them the flexibility to regulate complex products with multiple functions. The FDA has already applied this kind of logic to computer-aided diagnostic tools, which qualify for fast-tracked approval so long as the tools are comparable to those already on the market. This change not only makes it easier to build certain digital health technologies, but also sends a message to developers that the FDA supports the use and approval of this kind of tech in clinical trials. As such, certain sponsors and CROs like Novartis have already begun to use digital health tech to improve medication adherence and therapeutic support. Though the FDA has yet to announce specific guidelines for regulating digital health technology in clinical trials, the company has worked with the Duke-Margolis Center for Health Policy to release a set of best practices for the use and development of mHealth tech in this setting. In 2018, we’ll see even more digital health tools make their way into clinical trials. These technologies – like compliance apps, data capture tools, and remote trial delivery systems – will support sponsors and CROs as they work to improve patient retention and reduce costs. A Renewed Focus on Patient Centricity In 2018, the industry trend toward patient centricity will continue to grow. The industry already recognizes the value that patient centricity can provide; in a recent survey, 79% of respondents reported the belief that patient centricity is a meaningful initiative for clinical trials to pursue. In the coming year, trials will continue to incorporate patient centricity initiatives and improve patient feedback pipelines so they can increase rates of recruitment and retention. This coming year, clinical trials will continue to integrate the patient perspective into trial design and invest in technologies that streamline the patient experience. Sponsors and CROs will explore remote trials, telehealth, and digital health monitoring technologies to reduce site visits and improve follow-up. Other practices include partnering with ridesharing services to meet patients’ transportation needs and using centralized digital portals where patients can access trial information from the comfort of their homes. Employing the right kinds of patient centricity initiatives now will reduce costs of drug development in the long term. Better Analytics and Risk Management Software We also predict that 2018 will bring higher-quality analytics models to the clinical trial industry. These technologies can help sponsors and CROs improve the quality of trial practice and oversee vendors more effectively. Pfizer has already begun using a customized analytics platform to establish program- and study-specific key performance indicators (KPIs) and track progress toward those goals over time. Data visualization and tech integration across platforms should also improve across the board. Though widespread implementation of many of these technologies is still a long way off, 2018 will bring us closer than ever to streamlined, tech-enabled clinical trials. We’re looking forward to seeing how far the industry can go.