Pharma and biotech will increasingly turn to digital health tools over the next five years to better collect, analyze and act on patient-generated health data (PGHD), according to a research paper Validic, a digital health platform.
Research indicates the rise in acceptance and use of PGHD and digital health technologies are attributed to increased pressures to reduce trials costs, streamline processes, demonstrate real world-efficacy, address medication adherence and improve treatments for chronic diseases, as a press release from Validic notes.
According to survey results, over 60 percent of respondents stated they have used digital health technologies in clinical trials and over 97 percent said they plan to use these tools increasingly over the next five years. Findings from the survey point to the increasing prevalence of technology-driven clinical trials and growing need for automated access to real-time, remotely-collected patient data.
The study conducted over two months includes responses from nearly 200 global pharma and biotech companies, CROs and technology providers. Within those organizations, most respondents hold executive leadership positions closely followed by clinical operations professionals, innovation team members and information technology personnel.
The research analyzed the survey results and market trends to identify the key drivers fueling the induction and utilization of digital health technologies – in this study classified as wearables, in-home clinical devices, sensors and apps – and the patient health data generated from these tools. Some of the identified drivers include:
- The role of digital health data is changing. While the current use of digital health technologies in clinical trials is mostly focused on subject recruitment, remote patient monitoring and medication adherence, patient communities are expected to become one of the biggest growth opportunities for digital health in pharma. The study found engagement levels within these patient communities facilitates improved trial recruitment and post-market research. Additionally, medication adherence was flagged as the most important outcome and data point for drug developers by over two-thirds of respondents; while 100% of respondents concluded digital health technology improves medication adherence.
- Reducing drug development costs is increasingly vital. As drug development costs continue to escalate, pharmaceutical companies are facing increasing pressure to reduce trials costs, streamline trial processes and demonstrate real-world efficacy to a variety of stakeholders. These factors contribute significantly to driving the bottom line, cutting drug development costs and ensuring adequate return on investment – all necessities to remain competitive. By automating the collection of real-time data from digital health technologies, researchers are able to capture more accurate, holistic and objective participant data in less time with fewer resources.
- Chronic disease management remains important. Chronic conditions will be an increasing focus for pharma and biotech companies due in large part to their continuously growing prevalence among the U.S. population. As digital health has already played a crucial role in the prevention of chronic disease, seventy percent surveyed indicated patient-generated health data could have the greatest impact on improving treatments for chronically ill populations.
- Technical challenges for data access have been addressed. While the use of digital health technologies and PGHD in clinical trials is relatively new and stakeholders still have some lingering concerns, the technical and interoperability barriers for introducing these devices into trials have been overcome. Digital health is rapidly growing in size and scope; and with that, device manufacturers and app developers are entering the market with new tools and data points. Knowing which devices to use, how to access and integrate the data, and best practices for analyzing the data still remain concerns for respondents.
“The use of digital health technologies and patient-generated health data is becoming a proven necessity to the operational efficiency and patient-centricity of the pharmaceutical industry,” said Validic CEO and co-Founder Drew Schiller. “This remotely-collected data has the potential to reduce patient burden allowing for more passive engagement and data collection, while also improving the accuracy of data patients contribute during and after trials.”
“Wearable sensors, remote monitoring devices, and mobile apps all have great potential to help us understand how patients are responding to therapies,” saidKara Dennis, managing director of Mobile Health at Medidata, a provider of cloud-based solutions for clinical research in life sciences and a Validic partner. “We’re excited to be working through the operational and regulatory challenges with clinical trial sponsors, and to be guiding the industry through an intensive phase of exploration and implementation that will define the future of clinical research.”