How Technology is Modernizing the Clinical Research Process
Contrary to popular belief, the clinical research industry has not historically been at the cutting edge of health care. When I entered the field several years back, I remember registering surprise at the technology still being used at the time by some clinical research providers.
A major reason is that, outside of medical centers, organizations interested in doing medical research haven’t had a lot of technological resources provided to them. Even to this day, many aspects of clinical research are done manually. Electronic medical records have traditionally not been well suited for the research process, as they’re built around caring for patients and aren’t designed to collect data for studies.
Because of that, many smaller clinical research sites continue to operate on spreadsheets — going into groups of patient health records and running a report for certain diagnoses and lab values, then manually tracking every call and follow-up to build a list of interested, eligible patients. As you can imagine, this can be a tedious, time-consuming process.
Among clinical research professionals, two recurring issues tend to come up: recruitment and retention. In both areas, we at ObjectiveHealth believe that these processes can be improved with the use of cutting-edge technology.
To that end, we’ve been taking a look at the work processes being used at research sites and gradually building a suite of innovative tools to fix the problems we see operationally.
In 2022, we introduced ObjectiveScreen, a technology that connects to electronic record systems across multiple providers, helping to identify patients who are most likely to be eligible for clinical trials. Even better, this AI-driven technology learns from the data it collects, building algorithms that gradually improve over time, speeding up the recruitment process for each successive trial.
In our studies, ObjectiveScreen has been especially effective at identifying patients with a condition called nonalcoholic steatophepatitis, or NASH. Since NASH is a silent, chronic condition, patients often aren’t diagnosed accurately at first. By examining health records for risk factors like diabetes, obesity, hypertension, hyperlipidemia, and abnormal biomarkers, ObjectiveScreen can point us toward potential candidates for novel treatments that are available through clinical trials.
One reason why ObjectiveScreen works so well is because of the kind of research company we are. Our study coordinators are embedded with our care provider partners, operating an advanced research department at these sites. Our study coordinators monitor for upcoming patient appointments and use ObjectiveScreen to examine each patient’s medical history to stratify their risk for undiagnosed conditions. From there, they can intervene and suggest clinical research as a care option to patients who are at risk for a condition that might not be currently treatable or who aren’t responding well to their current treatment.
Only a small percentage of patients who are initially flagged will still be eligible for a study following subsequent screenings. However, by casting a wide net and using ObjectiveScreen’s technology, we’re able to recruit three times as many patients than before, resulting in six to eight weeks’ faster enrollment.
Retaining patients is another matter entirely. Our success in this area — a 90% patient retention rate, compared to a 70% industry average — is a result of using technological tools while also utilizing the strength of doctor-patient relationships. Because we’re physically located within practices, we have the advantage of patients viewing our research as an extension of their existing care plan, which increases their willingness to participate.
From a technology perspective, we engage our patients virtually, sending out educational materials and text messages to coordinate visits and remind them of upcoming appointments. We also continue to monitor patients longitudinally over multiple visits, so if they are interested in participating in a study but don’t make it through the screening process initially, we’ll follow up with them when there’s a new study to see if they’re still interested.
We’ve also recently introduced ObjectiveView, an advanced analytics platform designed to give trial sponsors deeper insight into the full clinical trial process, from recruitment all the way up to enrollment. This tool empowers sponsors, allowing them to continually monitor the progress of their studies, identify potential roadblocks, and understand the underlying cause of any issue that may arise. With this information, sponsors can collaborate with sites to quickly and effectively address any challenges by adjusting their recruitment and screening procedures.
ObjectiveView is an invaluable tool for trial sponsors seeking to optimize their clinical trials by providing real-time data and insights into the progress of their studies. By using this platform, sponsors can better understand the challenges and hurdles associated with their trials, and take proactive steps to improve the overall trial process, ultimately leading to better outcomes.
Moving forward, we’re continuing to think about how technological solutions can elevate the work we do, including additional patient-facing tools that could potentially help further with retention issues. We’re constantly chasing a more efficient, streamlined version of clinical research that eliminates grunt work and focuses on delivering clear, actionable results for sponsors.