How To Operationalize Diversity In Clinical Trials

Changes are quickly taking place regarding the push for patient diversity in clinical trials. For years, sponsor companies have been trying to increase the number of ethnic and diverse patients in their studies. Soon, they will face tougher oversight.

In May 2022, the FDA released guidance on patient diversity in trials, which may soon require drug developers to submit their diversity enrollment plans to the agency. And the Diverse and Equitable Participation in Trials (DEPICT) Act, introduced by three congressional representatives in February 2022, is legislation aimed at boosting diversity in clinical trials by requiring enhanced data reporting on clinical trial demographics and providing resources to improve access to clinical trials.

“Since its inception, Cerevel has prioritized diversity, equity and inclusion across all facets of the organization, with a particular emphasis on thoughtful clinical trial design,” says Dr. Stacey Versavel, PhD, Senior Director of Clinical Operations at Cerevel Therapeutics. “We are pleased to see that the industry is making a formal move to prioritize diversity in clinical trials.”

Create A Guidebook For Diversity

Although Cerevel is a young company, it is hardly like other startups. Cerevel has more than 200 employees and ten programs in its drug pipeline. The company acquired the assets when Pfizer divested their neuroscience therapeutic unit.

“We launched in 2018 with the goal of becoming the premier neuroscience company, and we immediately hit the ground running – starting up multiple clinical trials to understand the effectiveness of these potential new medicines,” says Rich Gleeson, head of clinical and R&D technology for Cerevel. “We knew that we needed a system that was compatible with the quick pace of our team and our sophisticated processes. The decisions our clinical teams needed to make had to be done thoughtfully and quickly to deliver on our goals.”

Dr. Versavel notes the company prospectively developed a diversity, equity, and inclusion (DEI) guidebook to assist clinical study teams. She states the guidebook will help sponsor teams think about diversity throughout the life cycle of a clinical trial, from design through to planning, startup, implementation, and closeout.

“There are elements derived in this guidebook from various functional groups within the organization,” says Dr. Versavel. “They will help our clinical study teams think about DEI as a best practice. The guidebook was developed and implemented last year, which was prior to learning about the DEPICT Act and the new FDA guidance. We are proud to have been ahead of the curve.”

A Focus On Technology

From the time it was formed, Cerevel wanted to build a next generation biotech company from an IT perspective. The company wanted to be fast, nimble, and lean, understanding the efficiencies that are gained from smart systems.

Gleeson notes that until a few months ago the company owned no servers. “The technology we use to run clinical trials is all cloud and SaaS based,” he says. “Many companies instinctively want to build systems from scratch. Our organization preferred to leverage managed services and third parties as much as possible to buttress up a smaller, dedicated IT team.”  

One of the downsides of using SaaS providers and operating in the cloud is that clinical trial data can wind up thinly spread across the internet. Gleeson notes the company still wants to bring its trial information into a single location so as to develop analytics to provide oversight, keep track of patients and adverse events, and track pharmacovigilance. To do so, it needed a partner to help with the overall architecture and strategy.

The Search For A Solution

Cerevel performed a search for a product that would help it monitor site recruitment and foster greater diversity among enrollees in its clinical trials. Unfortunately, most of the products it looked at failed to meet the company’s requirements. Gleeson notes the companies he spoke to generally fell into one of three buckets. There were the pure technology companies that had a product and wanted to build a custom solution on top of it, which can give sponsors the capabilities they need, but with the risks and pitfalls that come with building your own solution. Taking that route can also take a long time to complete.

Another bucket is data/analytics companies that are not specific to pharma or clinical trials. Gleeson found there was a considerable gap between the capabilities of those products and Cerevel’s requirements. He also felt those companies did not fully understand the business of clinical trials. Therefore, the longevity of those relationships and products could present risks.  

The third bucket is companies in the clinical space that have adopted technology. One of the companies Gleeson spoke to was eClinical Solutions. Gleeson felt their product was one that met the company’s needs and could be implemented quickly. It would also meet the managed service and analytics part of Cerevel’s strategy.

“The time to value was much shorter than for many of the other products we looked at,” he says. “We tried to cast a wide net and look at different strategies and different types of companies. This product best matched our cloud architecture and use of managed services. They also provided services such as the mapping and ingestion of data which allowed us to quickly make use of the product.”

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Real-Time Participant and Patient Data

The results have proven successful. “Following the development and rollout of these tools, our clinical team was able to look at data in real time,” says Dr. Versavel. “We can now look at the demographic data for participants and patient populations relative to our global sites over the course of conducting a clinical study. If we think we are lagging in implementing applicable defined elements of the DEI guidebook in a certain clinical study or a certain geography, our clinical study teams can have discussions about solutions sooner rather than later to course correct.

Dr. Versavel states an underperforming site might also cause the company to question whether patients and/or participants have the resources they need to enroll in a trial. If diversity seems to be an issue at a site, that might prompt the company to consider how it can assist with additional resources, such as a cell phone, transportation, or vouchers for travel and food.

“If we need to change our plan during the course of a trial, the data platform enables us to do that,” says Gleeson. “I once had an instructor who told me you can’t fix what you can’t measure. This whole experience of putting together a DEI report has helped prove that adage to me. Today, if someone asks me a question about how they can view certain information, I can assist them. I can quickly mock something up in the tool, get that to our data management team, and they can make the request a reality. With our cloud-based tools, data standardization, and technology, we can quickly answer any questions that arise.”

Overcome Implementation Challenges

When asked about challenges faced with the implementation, Gleeson mentions two. First, he notes deployment is easy, but adoption is hard. The focus for many technology companies is often on deployment. Once they get the technology installed, they will declare victory and leave.

“Adoption is more difficult because it’s about changing people’s daily lives and how they’re using technology,” he says. “It’s about working with data management teams, conducting webinars and meetings, and connecting with the user community to make sure they understand how the system works. You want to make sure you engage with a company that is willing to do that.”

The second challenge related to the product. Gleeson states most products, out-of-the box and off-the-shelf, won’t perfectly meet a company’s needs. The product was not 100 percent exactly what Cerevel wanted or needed, and there were times it wanted to make a change to a dashboard or add certain indicators. The technology was able to support those changes.

“When evaluating different products, that is generally your trade off,” he adds. “It’s time versus perfection. You must also think about optimization. Features that may be more important for us may not be that important to others. Our clinical study team is ensuring that we are representing D&I adequately within the scope of our trials. So, there are certain aspects of the platforms that benefit us more than others. We benefit from that flexibility.”