Belong.Life has expanded its digital clinical trial matching program to include patients with multiple sclerosis (MS). The technology uses advanced artificial intelligence (AI) that processes a patient's medical data and determines which trials in its global database are appropriate. The app typically returns results, which are prescreened by a clinical trial coordinator, in less than two days. More than 8,000 cancer patients have used the program so far.
The sheer volume of clinical trials proves daunting for many physicians and patients. Even well-informed and determined patients encounter challenges with the technical language used and the very granular nature of the inclusion and exclusion criteria.
“Physicians, on the other hand, may be able to understand them, but they are not aware of all clinical trials out there,” Irad Deutsch, Belong.Life’s co-founder and chief technology officer, told BioWorld. “In the best cases, they are aware of the clinical trials that take place in their own hospital/clinic.”
The combination leaves both many patients unaware of the trials that could be their best hope for a cure or remission and a high number of trials critically under-enrolled. Nearly 90% of trials require twice as much time as initially projected to reach their enrollment goals, and two-thirds never reach their target level of participation, reducing the quality of data essential for ensuring the safety and efficacy of new treatments.
MS patients often face an additional hurdle. “Some of them find it hard to concentrate over time, and many of them experience some cognitive difficulties (AKA ‘cog fog’ among MS patients). This makes it tough for them to digest the vast amount of information found within the clinical trials databases,” Deutsch explained. Cancer patients who have had chemotherapy have a similar issue with “chemo brain.”
Belong.Life’s mobile app uses AI and machine learning (ML) to digest the huge volume of data in the clinical trial database. “As a single clinical trial has between hundreds and thousands of different types of features – anything from geography and demography, down to disease history, and numerous clinical, emotional and behavioral characteristics of a patient – when you multiply this with the number of clinical trials out there, you end up with hundreds of millions of ‘data points’ that need to be processed in order to come up with a match,” Deutsch explained. “That’s where AI and ML kick in.”
The use of mobile technology for clinical matching reflects the goals of the Clinical Trials Transformation Initiative’s Digital Health Trials program, in which the organization participates. “The use of mobile technology holds promise for improving the quality and efficiency of clinical trials, increasing scale and reach, reducing participant burden and increasing engagement, streamlining study operations, and creating opportunities for collecting data that was previously unattainable,” the institute noted in a recent position paper.
Belong.Life uses AI algorithms to match patients’ profiles and treatment history to clinical trial catalogs and refine the list to find the trials most relevant to them. While the AI does “95% of the heavy lifting,” clinical trial coordinators make sure the data entered is accurate and complete, review preliminary results, consult with patients and develop the final short list that meets the individual’s preferences and needs, such as inability to travel significant distances.
The coordinator discusses the results with patients, allowing them to understand all their options. Sometimes, that leads to a second round of matching. The program returns the results of the search to patients directly but encourages them to discuss them with their physician. If desired, the coordinators connect patients with the trial site.
The clinical trial coordinators also play a critical role in keeping the data clean and improving the algorithm by validating the appropriateness of the matched trials and correcting errors so that the system does not repeat the same mistake twice.
Benefits to trial sponsors
“Pharma companies and [clinical trial organizations] are finding it harder and harder to locate the right patients for their trials, a direct result of the trial criteria becoming very granular over the years,” Deutsch noted. “As the Belong network has many patients, and our reach is far wider than any physical site, we make it easier for these companies to find eligible patients.” The opt-in nature of Belong.Life’s app ensures that only patients who wish to pursue clinical trials go through the process.
Belong.Life also assists sponsors with choosing the best locations for trial sites. Because its original app creates a very personalized social network for individuals, the company can identify areas that have large populations of patients who meet specific criteria. By opening a trial site in a spot with greater recruitment potential, companies can reduce their trial costs dramatically.
The mobile nature of the matching program has enabled sponsors to get their trials in front of eligible patients during the COVID-19 pandemic, even when those individuals could not visit the clinic or meet with their physician.
“Leveraging AI for remote clinical trial matching and performing these matches while patients are safe and comfortable at home greatly assists health care organizations bridge this gap,” Deutsch said. “Moreover, we are seeing an increased demand for virtual trials – analyzing historical de-identified data that can shed light on possible new therapies. This is where AI is extremely valuable – connecting the dots of different patients' journeys and finding a pattern that can help health care organizations to develop more effective therapies.”