The DIA 2019 Global Annual Meeting held June 23-27 in San Diego played host to approximately 7,000 pharmaceutical, biotechnology and medical device professionals from dozens of countries and more than 400 exhibiting providers of products and services that support the life sciences. As stakeholders gathered at this year’s Drug Information Association (DIA) event to share knowledge and advance health care innovations, the following three overarching themes continually resurfaced throughout the sessions and speaker presentations. Each is expected to be integral to redefining the future of clinical research and patient care.
In an era when technology companies and other providers are assuming ownership over more and more of our personal information, life sciences organizations are seeing imperatives to find new ways to help patients access and control their own data.
“Data is not just a concept or a fuel going through pipelines,” acknowledged Donna Cryer of the People-Centered Research Foundation. “Data is information about people’s lives and should be used to improve their lives.”
Given the sensitivity of patients’ personal information, life sciences organizations are awakening to the importance of giving their patients and research subjects greater involvement in clinical research data gathering activities.
“More and more patients are tired of being on the sidelines,” said Deven McGraw, chief regulatory officer of Ciitizen Corporation. “They want to be in there making decisions about their data.”
Yale University cardiologist and health care researcher Harlan Krumholz, M.D., said the best approach to improving the access patients have to their personal data is for life sciences organizations to engage in more clinical studies with people as partners. “We have treated research participants like prey,” said Krumholz. “We need to have intrinsic respect for people and let them pay it forward. The challenge will be in how we leverage digitization and how to do research better and more effectively.”
The transition from paper-based to digital processes is transforming the type and quality of data that can be collected in life sciences environments and the speed with which it can be put to use in creating new therapies. Finding the right balance between gathering high-quality data and utilizing revolutionary digital health technologies is proving to be both exciting and challenging in real-world settings.
“We are on the precipice of a massive data-driven change,” DIA Global chief executive Barbara Lopez Kunz said, “and that data will drive and define precision medicine.” Kunz said that the power of digitization will be the key driver of global connections and reshaping a global clinical landscape through the sharing of information and experiences. Toward that end, Kunz announced DIA’s recent hiring of its first chief digital officer, Bill Allman, formerly of Smithsonian Enterprises. DIA Global also presented Dr. Deborah Chee, president of Korea National Enterprise for Clinical Trials (KoNECT), with the Global Connections award for her efforts in promoting global collaboration and role in building one of the world’s leading clinical trials ecosystems.
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While digital transformation is helping life sciences professionals make unprecedented connections, it’s also compelling companies and agencies alike to grapple with the impact of evolving technology on the regulatory landscape and raising questions about best practices for regulating innovative mobile medical apps, wearable sensors, software as medical devices (SaMD), and other novel digital health tools. All eyes are on the U.S. Food and Drug Administration (FDA) as it continues to define its “least burdensome approach” to medical device premarket evaluation.
“We’re seeing more tools that analyze physiological data, but one of the biggest questions is how to do that thoughtfully,” said Hogan Lovells’ FDA Medical Device Group partner Yarmela Pavlovic. “You can see a lot of examples of the FDA trying to be creative, and there are a number of regulatory agencies around the world that are looking at the FDA as a test-case guinea pig but also as a leader.”
Discussions at the annual meeting about the role of technology in regulatory settings typically evoked excitement and trepidation in equal measures. Technology-focused sessions like the “Disruptive Technology Transforming Clinical Trials” panel raised four major challenges posed by rapidly advancing technologies and clinical researchers’ ability to keep pace without jeopardizing compliance.
Worries about technology advancing faster than it can be controlled are tempered by the strides being made by breakthrough technologies like the Emerald touchless sensor and machine learning platform for health analytics, which was one of many exciting innovations showcased at the event. Director of the MIT Center for Wireless Networks and Mobile Computing Dina Katabi explained how the passive in-home smart box uses low-level WiFi signals to track minute electromagnetic changes and record, monitor and learn from a variety of patient activities and biomarkers, from breathing and sleep patterns to gait and caregiver interactions. The AI-enabled system provides a glimpse into a future where health monitoring and patient care converts from wearable to invisible technology.
Just as exciting as developers’ groundbreaking innovations is the certainty that patients’ personal devices will be playing even broader roles in the clinical settings of tomorrow as the number of BYOD (bring-your-own-device) clinical trials increase in applicable instances. But the research that benefits from the use of patients’ personal devices in clinical trials will have to start with “first identifying the problem, then locating the appropriate tech,” according to Chris Watson, ERT’s director of product strategy – digital patient.
With so much data available, it is critical for life sciences organizations to ensure that collected data is tied to purposeful and substantive clinical benefits.
“For better or for worse, we are data-driven creatures,” said Paul Seo, director of the FDA/CDER/OPQ/Office of New Drug Products. “As scientists, it’s important that we consider the human aspect of this and view it from the bottom up. When you have patient-centric specifications, it helps scientists be better connected and bring the patient to the table. To change that mindset and culture, it starts with the data.”
Discovering novel data-gathering uses for AI, ML, blockchain, wearables, trial master file (TMF) management solutions and other advancing technologies is all the rage in the life sciences world, but expert presenters and representatives of regulatory agencies urged attendees at DIA Global 2019 to continually prioritize patient welfare, data quality and data security over technology.
“We can’t be interested in using technology just for the sake of using technology,” said Dr. Stephen Coons, executive director of Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). Just because data can be tracked doesn’t mean that it is meaningful, Coons admonished. “Not everything that can be counted counts.”
Using new technologies to collect meaningful data will help raise the bar in modern patient care to advance the best possible health outcomes, said Dr. Gary Gibbons, director of the NIH National Heart, Lung, and Blood Institute (NHLBI), in his keynote address.
“This is an opportunity to start to leverage new technologies, particularly the digital revolution, in which we can start to think about artificial intelligence, machine learning, and personal technologies to promote clinical decision supports, all of which are designed with patients at the center to improve outcomes,” Gibbons said. “But as we move forward with that new knowledge, it’s not sufficient for that to stay on the shelf in a journal article. We want to make sure it penetrates the real world of clinical practice and that patients actually get state-of-the-art evidence-based care.”
James Jardine is a marketing content writer at MasterControl. He has covered life sciences, technology and regulatory issues for more than a decade and has a bachelor’s degree in journalism from the University of Utah.