During 2022, ClinicalTrials.gov registered an additional 30,752 clinical trials, bringing the total record up to 430,269. Testing new drugs and treatments is a critical part of supporting public health. Clinical research ensures that patients can get the therapies they need to manage acute illnesses and chronic conditions.
However, the clinical trial process is often cumbersome. The journey to new treatments isn’t just time-consuming; it’s labor-intensive and costly. Fortunately, clinical trial technology is advancing, paving the way toward greater efficiency, higher accuracy, better accessibility, and improvements in patient diversity and inclusion.
Here’s a look at how tech is helping the clinical trial space.
Artificial Intelligence in Clinical Trials
Artificial intelligence (AI) is poised to revolutionize clinical research in several ways.
- Increase access to patient populations that align with the needs of a clinical trial
- Assist in analyzing data
- Identify study-specific patterns
- Streamline clinical trial processes.
Here is an overview of a few ways AI is making its way into CRO and clinical trial technology.
Patient Matching and Screening
Even with a capable contract research organization (CRO) leading the way and a well-developed recruitment plan, matching human subjects to clinical trials is often time-consuming and complex. Merely reviewing the inclusion/exclusion criteria to determine if a volunteer is a solid fit for the project is a lengthy process, and it’s only one of several steps during the recruitment phase.
Often, the onus is on patients to find clinical trials that align with their medical conditions, which isn’t ideal. With AI, recruitment is far less cumbersome. Electronic health records (EHRs) can be reviewed by the AI, allowing the system to identify potential matches and boost enrollment. While this would require patient consent – per HIPAA guidelines – it creates new avenues for attracting patients beyond what’s currently available.
AI has the ability to review large quantities of collected data to identify patterns, screen for adverse events, monitor patient participation, and assess progress and outcomes. This can reduce the burden on principal investigators (PIs), clinical research coordinators (CRCs), and CROs.
Additionally, an AI can alert the proper personnel if it finds concerning data, allowing those running the clinical trial to take immediate action when the need arises. This could include anything from reducing the impact of adverse events to following up on human subjects that miss appointments and more.
Finally, when AI is coupled with an Internet of Things (IoT) device – allowing for remote patient monitoring – it makes data collection convenient. Participants can simply wear the device while going about their lives, ensuring critical data is collected without creating challenges for subjects.
Telehealth Improving Clinical Trial Accessibility
Even when a patient is identified as an ideal match for a clinical trial and begins the enrollment process, challenges can arise when completing the required medical screening steps. Since the inclusion/exclusion criteria may require certain tests or appointment-based information.
While this isn’t a challenge for patients near the selected site who have flexible schedules, other potential participants may experience difficulties. Those with rigid work schedules, long commutes to the site, a lack of reliable transportation, or responsibilities that make traveling difficult may struggle to complete enrollment since these steps are often inconvenient.
Similarly, even when the enrollment process is completed, ongoing participation in the clinical trial can remain difficult. If it’s viewed as overly cumbersome by patients, it can lead to retention challenges that can harm the outcome of any clinical research.
With telehealth services, it’s possible to streamline participation on several fronts. It allows patients to connect with study and CRO personnel without having to travel to the study site. This can make the study more inclusive, making diversity goals easier to achieve.
Medication Adherence Assessments
Often, clinical trials rely on antiquated processes to track patient participation in regard to medication adherence. Paper diaries are the traditional approach, and that can lead to challenges. Patients may fail to record all of the required information when they take a dose, handwritten records may be hard to read, and they require manual entry into electronic systems at a later date. These burdens are time-consuming for study personnel and CROs and may result in more errors over time.
Fortunately, new technologies are looking to improve this part of the process. Smartphone app-based solutions can collect visual data, including performing facial ID checks to confirm the patient is taking the dose and ensuring the medication was taken correctly.
Additionally, any written records can be collected using a mobile device. Using survey-style toggles and checkboxes speeds up data collection. Plus, written records will rely on keyboard-based entry, ensuring its clearly readable. Finally, the data can be directly uploaded into technology solutions from CROs or study administrators, making it easier to monitor and analyze along the way.
Ultimately, technology is reshaping the world of clinical trials, increasing accessibility to underserved participants, streamlining data collection and analysis, and more. In time, clinical trial technology can decrease the demands associated with clinical research, all while creating an improved patient experience for those who volunteer to take part.