The future of diversity and technology in clinical trials

The science of medicine is moving with great speed, and healthcare providers are increasingly focused on a personalized approach that matches patients to specific treatment plans. But all these new medicines must be tested in rigorous studies, which can lengthen the time it takes to bring these treatments to a wider population. Luckily for patients, emerging technologies are reducing barriers to accessing treatment and expanding inclusivity in trials with methods including digital participants—some of which aren’t human patients at all.

During a recent virtual panel sponsored by Bristol Myers Squibb in partnership with Fast Company, industry experts discussed the future of the clinical trial space. Here are three key takeaways:

1. Clinical trials are becoming more efficient—and patients are benefiting.

The drug-development field is burgeoning. According to Michelle Longmire, M.D., CEO of decentralized clinical trial software maker Medable, it is crucial to focus on clinical trials because “the science of the therapeutics is at an all-time exponential growth phase,” citing spaces such as mRNA technology and immunotherapy. To leverage this flourishing industry, innovations in the clinical trial process can help get new therapies to patients more quickly and easily. Longmire added that there are currently more than 10,000 uncured and sub-optimally treated human diseases—but only 55 drugs are approved annually on average.

That is in large part because of the barriers to participation in trials which, among other challenges, can require travel and time that may be impossible for some patients. Jeff Elton, CEO of ConcertAI, which provides real-world data and artificial intelligence services to healthcare entities, pointed out that many traditional sites such as academic centers don’t attract enough eligible patients for a given trial, and recruitment can be difficult.

“Identifying patients for these trials often is more complex than it sounds,” he said, citing inclusion and exclusion study criteria like patients with rare diseases, certain comorbidities, or those who have been unresponsive to other medications. “Finding those [patients] in clinical workflows where physicians, nurses, and other care personnel are very, very busy can be quite challenging.”

Now, however, new technology may help remove many of those barriers.

2. AI and advanced data science approaches can enhance trials, in some cases with no human patient needed.

Complementing clinical trial participants with data from the real world is becoming more common in clinical development. What if a clinical trial could easily source ideal participants—ones who wouldn’t be inconvenienced by travel, because they’re not human? Data and AI are making that possible. It is the driving force behind “digital twins,” virtual representations of patients built on historical data. These digital twins are followed in real time to simulate the biological process and outcomes if a human patient with the same characteristics went through the clinical trial.

As Venkat Sethuraman, senior vice president of Global Biometrics and Data Sciences at BMS, explained, “We think, what does an average patient on a certain treatment in combination with chemotherapy look like? We have all the baseline characteristics and disease models: We can ask, what would a 65-year-old female with certain metastatic disease and certain biomarker expression levels disease progression look like, given all the knowledge and data we have [when taking this drug]?”

The concept may sound futuristic, but Elton revealed that digital twins are already being incorporated into trials today—not only to assist in recruitment, but also to enhance and speed insights. “It allows me to conduct that work, validate that work, and have different ways of reconfirming it as we come back to the actual [human] population,” he said. “This can streamline and speed cycles of insights into that disease state and how biopharmaceutical and other research groups can progress their work in that particular area.”

3. Sensors, pharmacies, and dedicated industry efforts can help expand access.

But digital twins are only as good as “the diversity of the data that we have,” Sethuraman emphasized. And historically, people of color have not been properly represented in many trials. “If you don’t have, say, women of color in that data set, then you’re not going to spin off a virtual twin who’s going to look like [that] population,” he explained.

Longmire has witnessed these disparities firsthand as a Stanford-trained physician, and it’s part of why she cofounded Medable. Earlier this year, the company announced a partnership with CVS to increase study access and engagement. Some CVS MinuteClinics will be equipped with Medable’s software, which can enroll patients in trials and even collect their data for studies. “When we look at the accessibility of, say, Stanford versus a CVS, I mean, compare the difference [in access] for communities across the United States,” she said.

All panelists agreed COVID was a catalyst in this respect, helping speed people’s comfort level with telemedicine, self-testing, and more: “The greatest experiment we’ve all witnessed in the last two years is the COVID experiment,” Sethuraman said.

“Technology is the bridge,” Longmire said. “But what we really need to be asking ourselves is: How can we be a part of communities? In the future, clinical trials will be a more integrated part of our daily lives. It will be a bigger part of our healthcare experience and a bigger part of our communities.”

IMPLEMENTING SOLUTIONS FOR THE FUTURE

Barriers to entry have long been a challenging reality for clinical trials—including difficulty in finding eligible patients, time and travel requirements that may dissuade participants, and a lack of diversity that may not reflect the wider population. These and other hurdles have led to delays in getting cutting-edge therapies to patients who need them, even as the science of drug development accelerates.

But new innovations are disrupting the clinical trial space. Technological advancements like digital twins can provide study insights with no human participant needed. And, in one positive side effect of COVID, patients are becoming far more comfortable with remote sensors and testing. Beyond helping accelerate drug approvals, these new trends can also greatly expand access to trials for patients across the country and prioritize diverse populations in future studies.

“People have gone through a lot over the last couple of years,” Sethuraman said, “and this is the perfect time to innovate.”