When it Comes to Diversity in Clinical Trials, Big Data is a Big Deal
Randy Marchbanks, senior vice president of the global operational strategy unit at the PPD clinical research business of Thermo Fisher Scientific, discusses how data can inform vital patient diversity goals for clinical trials.
In late 2020, the U.S. Food and Drug Administration (FDA) finalized its guidance for increasing diversity in clinical research to encourage the inclusion of underrepresented populations. While its end goal wasn’t new, the focus on the repercussions of not following this path had real teeth.
And for good reason.
For some time, the research community had raised concerns about drawing conclusions based on non-representative populations. They pointed to hypertension study enrollment that didn’t adequately reflect African American participation in clinical studies, despite this community’s high incidence of high blood pressure. They noted the absence of pregnant or lactating women in therapeutic studies designed to treat conditions that might affect them. And they pointed out that for conditions that can impact geriatric patients, related clinical trials are often under-enrolled when it comes to those over 65.
With this new guidance, biopharmaceutical companies are moving quickly to develop internal strategies to comply with the spirit of the new diversity and inclusion mandate. Many have reached out to the PPD™ clinical research business of Thermo Fisher Scientific seeking specific strategies we have developed and can deploy to support their efforts. It is clear from our customers’ actions and their sense of urgency that they are taking this updated guidance very seriously. It’s also clear that they require strategically impactful and operationally reliable solutions from their CRO partner to consistently deliver diverse and inclusive subjects in their clinical trials.
Preparation pays off
Over the past three years, we have invested heavily in diversity and inclusion guided by a global, cross-functional diversity in clinical trials (DICT) steering committee.
“We knew that we needed to tackle clinical trial patient diversity to ensure that research subjects proportionally represented the various cultural, ethnical, racial and socio-economic populations in the world,” explains committee co-chair, Rose Blackburne, M.D. “In the simplest terms, clinical trial participant safety and efficacy data should be inclusive and reflective of the patients that will ultimately use the drug, device or diagnostic test being developed.”
In 2020, as Thermo Fisher Scientific’s PPD clinical research team and our partners raced to enroll patients in COVID-19 vaccine and treatment studies, this underrepresentation of affected populations spurred a new urgency. Customers took note and rightly insisted that diversity recruitment efforts meet the moment, enrolling people of color who were disproportionately bearing the brunt of the pandemic.
This has been a challenge historically for all health care researchers for several reasons, including:
- Lack of understanding regarding clinical trials and low awareness of current associated regulations to protect informed consent and oversee safety of trial subjects
- Limited access to clinical trials due to unconscious bias, a limited number of principal investigators (PI) connected to underrepresented patients, plus fewer community physicians with clinical trial awareness
- Historic lack of trust in vulnerable groups due to real and perceived unethical clinical research practices
- Eligibility criteria that may be overly restrictive, unnecessarily eliminating subjects due to age and comorbidities
- Socioeconomic factors — both financial and environmental — creating barriers to participation
- Trial requirements that may be burdensome, including the length and frequency of visits required, duration of the trial or the actual trial site location
The pandemic exacerbated these factors, layering restrictions on travel, burgeoning illness, growing staff shortages and more. And yet it was vital that we reach our diversity targets for both treatment and vaccine trials.
Big data steps in to deliver diversity
Faced with requisite diversity targets of COVID-related trials, we worked hand-in-hand with our patient recruitment and site research business, Accelerated Enrollment Solutions (AES), to put a multipronged strategy into immediate action. Key to the success of that plan was the heavy reliance on data for planning and real-time data analytics for ongoing optimization.
One initial source for likely patients was the AES patient database with access to a more than 100 million household database with one or more opted-in patients; 20 million identified, prescreened, consented patients interested in clinical trial participation; and 10 million identified, prescreened, consented patients interested in clinical trial participation who provided race and ethnicity information.
The plan also called for data overlays — especially epidemiological studies to locate COVID-19 “hot spots” — and combined those results with trial site locations to engage a diverse patient pool.
“By combining our database and epidemiological data, we were able to sharply focus our direct-to-patient engagement campaigns and community outreach,” said Riaan van Tonder, head of global project delivery. “With so much pressure to get these trials up and running quickly, this strategic approach allowed us to meet enrollment goals for diversity in record time.”
The ultimate promise of big data is the ability for us to find the right patients with the right diseases at the right time … without a lot of wasted time or energy.
PPD Data Platform Captures Demographic Information
- Data from 22,000+ clinical trials to build benchmarks for clinical trial diversity
- Viewable by relevant cut including, race, ethnicity, gender and age
- Details from overall indication to site level to identify sites that disproportionately recruit diverse patent pools
- Real-world demographics in area and disease prevalence
Continued Commitment Provides Ongoing Value
Our internal initiatives continue to optimize diversity and inclusion considerations from study feasibility through trial conclusion. We recently boosted our bench strength in clinical research diversity when Lloryn Hubbard joined us after spending three and half years at Roche/Genentech where she was a project lead in medical affairs and the health equity population science team. During her time there, she actively collaborated with others to build one of the first diversity and inclusion programs in the industry. In addition, an internal data task force has pulled demographic data from thousands of our trials over the past 10 years to identify sites and primary investigators who were particularly successful at enrolling diverse patient pools.
By pulling that anonymized data and putting it into an analyzable file, we can pinpoint investigators with proven ability to enroll diverse patient groups. We’ll be able to do this across indications for very specific audiences — African Americans, Asian Americans, women, older adults — really any previously underrepresented group. And that means we’ll be able to build appropriately diverse patient cohorts for future trials.
While our diversity initiatives are responsive and in service to customers, they are also reflective of the company’s values. In fact, a sizable investment has just been made in multiple data subscriptions and data mining efforts.
The price tag may be high, but the promise of big data to deliver on diversity is priceless.
