Shawn Blackburn, Chief Executive Officer
Right now, your smart phone is likely within reach. You might be wearing a fitness tracker. Maybe you’re reading this on a tablet. Devices like these are at the center of modern living.
But they’re also the tools behind a new kind of clinical trial — one that’s more inclusive and streamlined. When paired with complementary technology like eCOA, IRT and other eClinical systems, these wearables and mobile devices can drive patient-centric studies that also benefit sponsors and investigator sites.
The Model for Virtual Trials
Unlike traditional trials, a virtual clinical trial takes place wherever patients are – at home, at work, even on vacation.
At study outset, a patient receives an eCOA-enabled mobile device. Instead of reporting to an investigator site, patients use the devices to fulfill study requirements. With assistance from trial support staff,— participants perform study-related tasks in their own time. These tasks could include:
- Diary or PRO completion.
- Real-time readings of vital signs or specialty measurements (like glucose monitoring, actigraphy or spirometry) through sensors or wearables.
- Video conferencing with research staff who can monitor safety, reinforce protocol adherence, confirm medication compliance, and provide other helpful guidance.
Trials with less complex assessments could take place in a completely virtual environment. Trials with more complex protocols could follow a hybrid model, using ePRO, telemedicine and in-person home health visits, as well as visits to local labs if needed.
Optimizing Data with Integrated Solutions
In addition to wearable and mobile devices, virtual trials also require robust behind-the-scenes technology solutions.
Virtual trials generate volumes of rich, real-time data. An integrated eCOA platform enables stakeholders to make the most of that data, providing reliable access and powerful management tools.
Virtual trials also rely heavily on eClinical system interoperability. Trials use numerous individual support systems and the continuous flow of data across these systems is critical to success.
IRT systems can ship study medications directly to patients, providing end-to-end drug accountability. Integrated eCOA and IRT systems can also provide sophisticated patient engagement tools that include alerts, reminders, scheduling assistance, education and information sharing.
The Case for a New Approach
Virtual clinical trials use modern innovation to remove the burdens and barriers inherent to traditional research. This new, patient-friendly approach:
- Widens and speeds recruitment. Because there’s no central investigator site to visit, patients can participate from anywhere. With a wider pool of potential participants, recruitment takes less time and studies are more likely to include underserved populations.
- Supports eConsent. Electronic platforms can make it easier to communicate complex consent information, using audio, video and interactive components. And metadata, such as time spent on each page, helps measure patient engagement from the start.
- Promotes safety. Real-time data and integrated eCOA can help staff and sponsors recognize adverse events sooner. In such an event, eCOA workflows allow sponsors to quickly distribute safety information and critical documentation to relevant recipients.
- Feels familiar. Given the popularity of fitness trackers and smart watches, many people are comfortable with wearable technology. In-home clinical trials using wearables and sensors make the research process less invasive and institutional.
- Streamlines the process. Site-less trials can be conducted with fewer resources. Reduced patient burden also helps minimize dropout that can derail research.
- Offers continual access to quality data, including new kinds of outcome measurements. With wearables and sensors, sponsors can track and analyze data that might not be available under other circumstances.
The Future of the Site-Less Trial
The virtual trial is still in its infancy as stakeholders address regulatory considerations and work to ensure patient privacy and data integrity. Many current trials, however, incorporate virtual elements such as telemedicine, direct-to-patient supply chain services and data collection devices that minimize required in-person site visits.
There are also some exploratory “full virtual” models being used, and the industry expects rapid growth. In fact, some estimate that half of pharma companies will conduct virtual trials by 2019.
As sponsors increasingly employ patient-facing technology (like wearables) and behind-the-scenes solutions (like eCOA and IRT platforms), clinical research will become more efficient. It will offer strong potential for higher quality data. And it will become more inclusive and patient-centric, helping to speed delivery of critical therapies — a common good we can all get behind.