Clinical trials can and should be available to a broad and representative population, not restricted by geography, ethnicity, socioeconomic status, or gender. Technology can play an important role in circumventing obstacles to participation and democratizing access to clinical trials for everyone.
Scott Schliebner, Executive Vice President and Chief Strategy Officer of 2M Clinical, explained that removing barriers to create diverse, representative trials is both the right thing to do as well as good science. Trials can help identify how certain drugs work within specific subpopulations. Trials can identify drugs that might pose safety risks to certain patient populations. Trials also can be prescribed preferentially to different groups.
Unfortunately, the current clinical drug development paradigm often prevents many people from having access to the care they need. Clinical research can be a legitimate care option for many people, yet access to clinical trials by underserved and underrepresented groups has been unequal at best.
“We rely on patients, and their data is the only way to move investigational drugs forward,” Schliebner said. “Yet, despite this, we are designing clinical trials without thinking about what is feasible for patients and the result is that our clinical trials are far too burdensome. We can do better in terms of considering our ultimate stakeholders—the patients themselves—and what is feasible and realistic for them. After all, patients are the ultimate stakeholders and clinical development of new treatments fails to move forward without their participation.”
Typical hurdles to clinical trial participation include time, travel, out-of-pocket expenses, and inconvenience. Traditional site-based clinical trials require patients to travel to physical sites, sometimes great distances, or across state, province, and country borders. This results in the need to take extensive time off from work for participation, and in many cases, is in addition to already managing a challenging or complex condition.
In the cases where children are the participants in clinical trials, it is really the entire family that enrolls in a clinical trial. Clinical trials that require excessive site visits, evaluations, and assessments routinely have large percentages of patients who withdraw, drop-out, or do not finish a trial due to the intense and unrealistic requirements. This, of course, causes further delays with clinical development as clinical trials drag on to meet enrollment goals and collect critical data on safety and efficacy.
Schliebner shared that decentralized trials (DCTs) can play a big role in bridging the diversity gap. He describes this model as an “Amazon approach” – using technology to bring trials directly to patients, as opposed to having patients travel to brick-and-mortar “stores.” For one, shifting clinical trials to more of a digital experience can reduce the time demands and inconveniences of having to visit a physical location. Technology also can advance medical care through mobile health platforms, connected devices, artificial intelligence, and machine learning.
Schliebner added that a common issue that occurs during clinical trial enrollment is when studies are looking for patients that don’t even exist. Leveraging data can help with this piece of the puzzle, too. Schliebner adds, “we often see clinical trials with dozens of eligibility criteria that every patient must meet to enroll. Sometimes, these overly selective criteria result in such a narrow window of eligibility that there are literally no patients who qualify.”
Dustin Arnold, Chief Technology Officer for 2M Clinical, and lead of the new NeighborhoodTrials.com platform, described how technology can help identify and match potential participants to relevant trials. Arnold said valuable data streams can be used for analytical purposes to identify potential participants for a variety of different clinical trials. Machine learning and artificial intelligence help sift through vast amounts of data and identify patterns that humans can’t on their own.
“We can use technology to improve the chances of connecting the right person to the right clinical trial at the right time,” Arnold said. “Being able to identify the person that’s in need and potentially provide the quickest path to them recognizing the value of participating in a clinical trial can be hugely impactful.”
You can also screen potential participants faster by automating qualification and disqualification assessments. This accelerates enrollment, informed consent, and other manually intensive processes in a clinical study by weaving technology into the right places.
We believe our NeighborhoodTrials.com platform incorporates the above-mentioned technologies to help patients find the trial that is right for them. Additionally, our Patient Engagement combines technology with a human element to increase the success of recruitment and retention efforts.
A patient-centric mindset lets us take a step back to see how people prefer to engage and how they live their lives. People use digital technology for a wide variety of activities and expect healthcare to integrate technology, too. A 2020 FDA study found that about 75 percent of people preferred a mobile clinical trial compared to a traditional trial. Technology also enhances communication between all parties and patients during trials and beyond. Mobile health platforms and wearable devices can replace the need for in-person visits and checkups.
Telehealth has emerged as a crucial care-delivery method for providing essential care to the most vulnerable populations, particularly during the pandemic. The use of telemedicine and digital engagement for healthcare continues to rise, due in part to COVID-19 reactions.
“One silver lining of the pandemic is that people realized we need to do things differently and evolve,” Schliebner said. “Another thing COVID-19 spotlighted was disparities that exist in our world in a lot of different areas, one of those being access to health care.”
Integrating technology into clinical trials can create better science as people get the care they need at home, right at their fingertips. Fewer site-based visits and evaluations can help reduce barriers that keep many from enrolling and can make clinical trials a truly viable care option for minority groups who have traditionally been excluded.
Schliebner and Arnold acknowledge it takes effort to evolve and harness technology and data, but they’re encouraged to see biopharmaceutical companies make more of a concerted effort toward inclusive and representative trials. Technology can play a pivotal role in achieving this goal by allowing people to participate in a trial that keeps them at the forefront.