The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June—an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market.
The FDA issued new draft guidance that stated its intent to not actively regulate certain health IT devices. It also signaled that IT products that straddle the line between IT and devices would also be exempt. This is good news for mHealth solution developers and health sciences organizations engaged in clinical development, clearing the way for faster development and more confident adoption.
mHealth technologies hold great potential to transform clinical development programs, including clinical trials. Health sciences organizations and their contract research organization (CRO) partners have been focused for the last two decades on improving the productivity of clinical trials by boosting data collection and management efficiency. After many years, electronic data capture solutions have become the industry standard.
In contrast, the industry has made limited progress on improving the fundamental quality of clinical trial data. This is where mHealth technologies have the opportunity to take center stage and drive much-needed transformation.
Wireless technologies, including many types of remote sensors and wearable devices, have advanced at a breakneck pace in recent years, driving innovation across many industries as well as delivering new levels of consumer convenience and connectedness. With increased and clarified guidance from the FDA, the mHealth sector is now poised to more confidently capitalize on these advances and fuel new innovation of its own.
Using mHealth and other machine-to-machine (M2M) solutions, trial sponsors and CROs can improve data quality and accuracy. They afford organizations the ability to collect higher volumes of information and an expanded array of data types from trial participants, which supports more thorough analysis and more informed insight. As important, automated data capture removes the risks of errors associated with manual data entry.
mHealth and other M2M technologies enable continuous patient monitoring that can deliver important advantages to research teams because of the volume and variety of data collected. Sensors and devices, for example, can collect continuous data on physiologic vitals as well as activity levels and types, which can yield important insight into efficacy not possible with traditional patient journals and periodic exams.
mHealth solutions can also enable immediate capture of data without human intervention, accelerating delivery of important data and indicators to researchers. This immediacy can help researchers to identify potential adverse events sooner to improve safety as well as accelerate the overall pace of data collection, helping to speed time to data lock and regulatory submission.
Similarly, immediate access to data can provide greater visibility into a trial participant’s adherence to the study protocol. If a trial participant is not adhering, trial managers can quickly identify this and drop them from the study or explore other ways to help boost adherence across the participant pool as a whole. This enhanced visibility yields earlier insights into how many subjects will be required to complete the trial and, ultimately, accelerates the clinical trial cycle.
As important, access to real-time information can support adaptive trials, providing early indications of changes that might need to be made to protocol, sample size, or trial scope. Likewise, trial sponsors can have earlier insight into a therapy that is performing better than expected, which would accelerate the delivery of life-saving treatments to market.
The advent of sophisticated wireless technologies that have the potential to collect unprecedented volumes and varieties of data accurately and in real time has the potential to transform the pace, safety and success of clinical trials. New and clear guidance from the FDA stands to give technologists and health sciences professionals the insight they need to proceed confidently in exploiting the full potential of mHealth solutions.
Mukhtar Ahmed, Vice President, Product Strategy, Oracle Health Sciences