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For decades, clinical trial recruitment was a one-way, transactional process. The quickest route to getting innovative drugs to market was through a flawed system that emphasized gathering a quality data set over the simultaneous need to ensure collected data reflected a diverse patient population.

Compounding this challenge is the fact that nearly two-thirds of drug trials conducted in the past five years were conducted outside the U.S., with many of those trials being conducted in countries with less diverse populations. Fortunately, times are changing for the better.

Converting to real-world data has been slow

In 2001, the National Institute of Health (NIH) mandated that women and members of other minority groups be included in any NIH-funded clinical research to more accurately reflect the real-world patient populations that ultimately use the products being researched.

However, nearly 20 years later, the industry still struggles to recruit representative populations. In fact, among new molecular entities and biologics approved in 2020, just 11% of study participants were Hispanic, 8% were Black and only 6% were Asian.

In 2020, the U.S. Food and Drug Administration released its final guidance, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs. This initiative will promote study diversity, more accurately reflect real-world patient populations, and obtain relevant safety and efficacy data specific to those populations. This aims to result in a larger, more equitable and diverse data set detailing the clinical and safety impact of a given therapy within specific patient subgroups that may have been underrepresented otherwise.

“At Otsuka, we are prioritizing the use of real-world evidence to ensure we adequately represent different patient populations in our trials. Over time, our evidence database will include anonymized data from hundreds of thousands of patients. The more data we have, the higher the likelihood is that we will get an adequate representation of each community we serve.”

Shuvayu Sen, vice president, Value and Real World Evidence Health Outcomes, Otsuka Pharmaceutical Development and Commercialization, Inc.

Digital technology can help bridge the physical divide

Another aspect of democratization of clinical trials is the role played by technology. The emergence of electronic patient records improves researchers’ ability to get meaningful endpoints out of real-world evidence. As the number of datasets increases, artificial intelligence software will enable comprehensive analysis of that big data in completely different and beneficial ways.

Digital technology also helps alleviate the burden of travel. The inability to physically get to a center is one of the biggest barriers to diversity in clinical trial participation and disproportionately impacts those living in underserved communities. An NIH study showed that lower income patients traveled up to twice the distance than higher-income participants. The virtualization of clinical trials can help to broaden access.

Companies like Otsuka Pharmaceutical Development and Commercialization, Inc., have pioneered innovative solutions to digitizing trials over the last five years by leveraging tools such as eConsent, eSource, and eScanning of clinical supplies to provide real-time insight to trial activities. Through collaborations with industry leaders such as Verily Life Sciences, Otsuka has developed innovative solutions to virtualize clinical trials that drive greater patient-centric research, while being committed to ensuring patient safety, data integrity and trial optimization. As an example, in 2020, Otsuka designed and launched what may be the first completely virtual clinical trial. The study is focused on identifying new and better ways to engage more patients and clinicians in research, increase the speed and ease of conducting studies, and collect more comprehensive, higher quality data, outside the four walls of a clinic.

Democratizing clinical trails and beyond

Advocating for and delivering on diversity and inclusion in clinical trials is a step in the right direction, but access to these beneficial medications is critical to avoid health disparities.

Digital innovation will be a key factor in bringing this to fruition, while still incorporating the human touch throughout the journey to provide personalized support when and where it is needed. Only then can true diversity and democratization of clinical trials be achieved. It’s time to meet people where they are.


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