Improving Clinical Trial Diversity Through Community and Pharmaceutical Relationships

November 28, 2022 - In the United States and worldwide, clinical trials play a vital role in developing, testing, approving, and rolling out medical interventions. In the US, the FDA monitors and regulates clinical trials, using the results to decide whether to approve, expedite, or recall medications. Despite the impact of clinical trials on healthcare, their diversity is sorely lacking. The issue of poor clinical trial diversity may be partially addressed by developing relationships between community sites and pharmaceutical companies through global platforms.

Lack of Diversity in Clinical Trials

According to a Phesi analysis published earlier this year, despite Black patients having the shortest cancer survival rates, over 40% of cancer clinical trials do not include any Black patients. Although they are one of the most significantly affected populations, this situation is not unique to Black cancer patients. Nearly all marginalized communities are underrepresented across a host of different diseases. Affected communities include LGBTQIA, disabled, and other minority individuals.

Impact of Lack of Diversity

The impact of disparities in clinical trial diversity goes far past the duration of the trial itself. Since the results of these trials are used to make regulatory decisions on medications, regimens, devices, and other healthcare tools, the impacts are long-lasting. Healthcare tools tested and approved based on information collected from predominantly White individuals may not work as well for different ethnicities.

Recent examples are racial discrepancies in pulse oximeter and thermometer readings. A publication in JAMA Internal Medicine in July 2022 found that pulse oximeter readings for Black patients were 1% greater than that of White patients despite Black patients having lower blood hemoglobin saturation. Amidst the COVID-19 pandemic — when pulse oximeter readings were used to determine whether patients should receive supplemental oxygen — the repercussions of this discrepancy could be severe.

Shortly after the release of that article, a research letter published in JAMA Network Open found that Black patients’ temporal thermometer readings were an average of 0.07 °C lower than their oral temperature thermometer readings. Conversely, the discrepancy for White patients was less than one-third as much at 0.02 °C.

These variations represent two of many examples of a lack of equitable care. This can be partly attributed to a lack of clinical trial representation for marginalized communities.

Current Clinical Trial Landscape and Challenges

PharmaNewsIntelligence interviewed Kourosh Davarpanah, CEO and Co-founder of Inato, and Teresa L. Tocher, Director of Clinical Research at Clinical Trials Management Services, LLC, who provided some insight into the current, traditional clinical trial landscape and how clinical trial sites are connected with pharmaceutical companies to offer their patients access to care.

Location

They both told PharmaNewsIntelligence that patients being treated outside of major academic centers are at a significant disadvantage regarding trial access.

“The issue of patient access is that if they are not treated in one of the large academic hospitals they typically do not have access to the right trials for them as a patient. Not only is it an issue for most patients, but it's an even bigger issue for diverse patients, especially ethnically diverse patients that typically aren't treated in those large academic hospitals,” said Davarpanah.

He continued, “if a patient is African American, for example, they don't even really know if the drugs that are now on the market work for their ethnicity because it wasn't tested on people like them. This issue is a global issue whether the patient is in the American system, the French system, or the English system. Even though they are very different healthcare systems, they're still organized in pretty much the same way, with the large academic sites being in the major cities and the secondary sites being left out from the research.”

Identifying the appropriate clinical trials for their patients is incredibly complex for many doctors. With thousands of clinical trials worldwide focusing on the same diseases, determining which trials are best can be daunting. Moreover, access to these trials can pose an additional barrier for providers working at smaller community sites instead of larger academic sites.

Availability

Beyond issues associated with location, Tocher outlined how she, as a community site representative, struggles to find available studies.

“The biggest issue community sites face right now is finding the available studies looking for new sites. I reach out to sponsor companies and clinical research organizations (CROs) directly, and often they'll refer me to their website, but nobody gets back to us, and they don't list what's up and coming,” she shared. “Or if they do get back, they refer our site to clinicaltrials.gov. But once studies are posted on clinicaltrials.gov, it's usually when they're already up and running. It's not looking for new sites.”

Tocher noted that this back-and-forth communication is usually futile and unsuccessful in connecting with a new trial to enroll as a treatment site. There needs to be a way for smaller community sites to communicate with big CROs early in the enrollment process.

“We have a broad network of patients in Ventura County, different ethnic groups, and so on. But unfortunately, we only have the attention of a couple of sponsors and CROs who know about us, so we are trying to raise awareness of our location, our patients, and the things that we can do on a broader scale,” added Tocher.

Inato Platform

In a press release earlier this month, Inato debuted its new Check Your Fit tool, aimed at addressing issues of clinical trial diversity by bridging gaps between community centers and the pharmaceutical companies or CROs who typically run these clinical trials.

“Inato is leveraging what is already working well in the healthcare systems,” began Davarpanah. “There are many community hospitals globally that are not naive to research. They already run between one and 20 trials a year. But what they're struggling with is getting access to more trials and getting access to the right trials for their patients.” 

Davarpanah explained that the platform flips the existing model on its head. Rather than the community site spending time trying to get in touch with CROs, this platform helps providers look at various studies posted by pharmaceutical companies and CROs.

“Instead of chasing studies, community sites can proactively identify the best studies based on their patient’s needs and site capabilities. Inato will help these sites showcase to the sponsor that they’re motivated and have access to the right patients. We’re also going to help these sites reliably estimate how many patients they can enroll in the study,” he expanded.

The Check Your Fit Tool

Davarpanah shared that the Check Your Fit tool begins with a quick two-minute assessment for each community site to complete. “Within two minutes, sites can assess if this is the right study for them, and they should invest time and effort trying to assess how many patients they could enroll or if it's not the right fit,” stated Davarpanah.

The assessment asks the site questions critical to determining whether a site is a good fit for a clinical trial. The information is only input into the platform once, and Inato can continue to reuse it to match the site with a clinical trial or determine whether a trial is a good fit.

“We end up with this very holistic knowledge of our sites, but we do it in a way that provides a good user experience, not in a way where sites feel like they have to spend hours filling up information without having anything in return,” claimed Davarpanah.

He emphasized, “Inato is trying to create a world where the doctor and the patients are the ones that are saying this is the right trial for my patient instead of pharma companies leveraging the clout that they have to tell sites they need to do this trial even if it’s not the best one.”

Tocher, whose community site uses this tool, described its experience with Inato and the Check Your Fit tool. “They have everything listed right there, all the therapeutic areas in one spot. I can see what's coming up and what CROs are looking for and immediately know if it makes sense for my office,” she stated.

“It's been very beneficial to me to know what's out there because there are studies listed on there that I wasn't aware of before that we're applying for now, which makes a big difference for the types of patients that we serve,” continued Tocher.

Overall, Davarpanah and Tocher seem to have high hopes for the impact of this tool on clinical trial access and diversity. As the platform is rolled out and implemented, the company must determine what metrics to use to assess its efficacy. Although this tool may move us toward diverse clinical trials representative of patient populations, it is just a tool. For real, lasting change, it will take an interdisciplinary approach involving tools — such as this one, providers, patients, policymakers, and pharmaceutical companies.