How to Improve Diversity in Clinical Trials: Achieving an Industry Imperative

CLINICAL TRIALS

How to Improve Diversity in Clinical Trials: Achieving an Industry Imperative Katrina Rice Chief Delivery Officer, Data Services eClinical Solutions Improving diversity in clinical trials is an industry imperative for achieving health equity. In an analysis1 reviewing participation of racial and ethnic populations at US sites between 2015 and 2019, the authors confirmed low proportions of some racial and ethnic groups. The study found the data highlighted the need to increase diversity in US clinical trial participation. Meanwhile, in a study2 of 167 new drugs approved by the FDA between 2008 and 2013, one in five had differences in exposure, response, or both across racial or ethnic groups. Considering patients of various backgrounds may not respond the same to diseases or treatment, there needs to be better trial representation, including people with varied living experiences, living conditions, and personal characteristics like age, gender, race, and ethnicity. This will help us more holistically understand the safety and efficacy of different therapies and ensure all communities can benefit from scientific advancement and discovery.

There is intent to improve the status quo, as well as a push to require proof of our progress. This is evidenced by the FDA updating their guidelines3 to address inequities in healthcare and improve diversity in clinical trials. There are a variety of ways our industry can achieve more diverse and representative clinical trials. As we work toward these goals, modern data platforms and analytics will increasingly become a key component, providing researchers with the insights needed to ensure diversity in clinical trials is measured and attained.

Encourage Industry Representation Institutionalizing a more diverse workforce across clinical development has a key role to play. The under-representation of minority racial and ethnic groups in clinical trials is harmful, and in order to address this problem, representation across the entire industry matters. In my nearly 25 years working in clinical trials and as a Black female leader within this industry, I’ve observed first-hand the limited representation of diversity that is present in all areas, not just among trial participants. We must look to drive diversity from Pharmaceutical Outsourcing |

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the top down, and to do that, we need to make a concerted effort to recruit qualified people from diverse backgrounds to join life science companies, particularly in leadership positions. Studies4 have shown people are more likely to trust someone who looks like them.

Poor representation impacts researchers’ ability to connect with and attract participants from differing backgrounds. In order to achieve the overarching goal of expanding diverse participation in trials, we need to first improve diversity among those working across life sciences and in clinical trials. Not only may it shift the perspective of those considering trial participation, it will ensure our industry incorporates the diversity of thought and experience necessary to realize a future of equitable healthcare.

Leverage the Rise of Virtual Trials Virtual and decentralized clinical trials (DCTs) are not a novel concept, but their popularity rapidly accelerated due to the pandemic, when people were staying home and not traveling to site locations. DCTs use technology to reduce visits to a central research site, thereby removing geographic barriers for potential participants who might not have convenient access to transportation, or who do not live nearby trial sites. One of the primary goals of DCT study designs is to widen the net of potential trial participants, including those from diverse populations. DCTs are able to achieve this goal by reducing or eliminating travel to and from the trial site, creating a trial design that incorporates flexible, local and home-based data collection technologies and methods. By increasing the use of DCT and virtual trial components, sponsors can utilize the technologies people use every day (such as smartphones, smartwatches, etc.) to make it more convenient and accessible to be in a clinical trial. Geographical barriers aside, there could be a lack of reliable transportation, a disability or injury that makes travel to a site location challenging. Removing these obstacles expands opportunities for both the trial and the patient.

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enrollment, helping promote an increased willingness to participate.

By increasing the number of trials incorporating DCT elements, trial sponsors are likely to reach a larger population because of more convenient participation.

Design for Diversity Technology in and of itself is not a magic solution, but should be thoughtfully applied for the maximum benefit. We have to consider - is the technology too cumbersome, or too complex? No participant wants to carry two cell phones, and having to learn to use a new device or complicated technology could be a barrier for participation.

Prioritizing technologies that are already in use day-to-day expands trial access for a variety of people. Introducing new or less familiar technologies could greatly enhance a trial’s data, but we must commit to providing ample training and support for patients. In addition to breaking down barriers and enabling access for diverse trial populations, technology should improve the trial experience and make it easy and convenient to be part of a clinical trial. Technology is also not the only way to meet patients where they are. As an involved member in my local community, I see potential for biopharmaceutical companies to partner with communities to help better drive diverse enrollment. If companies partner with local agencies or organizations within communities, this could expand opportunities to reach patients who may be desired for a specific study. Enabling patients to participate in trials from their own communities rather than traveling to a trial site location is an important trial design consideration, as it removes geographic barriers to participation. Making participation easier and not a burden on patients must be a priority from the earliest designs of our clinical studies.

Another consideration is the data we collect, and managing the quality of that data. This year, approximately 460 wearables studies5 are underway and 70% of clinical trials6 are expected to incorporate sensors by 2025. The boom in wearable health technology has coincided with the rise in virtual trials, which as a result has caused a rise in data streams clinical researchers must now learn to manage.

Its imperative sponsors do not waste time collecting data they don’t need, and instead focus on leveraging the data that provide critical insights for safety and efficacy, as well as the data needed to monitor for diverse representation throughout the course of the trial.

Companies and industry leaders need to consider what elements can be discussed and integrated in the early stages of a trial that can then be carried out throughout the trial’s lifecycle to help achieve the end goal of improving diversity.

Build a Foundation for Digital Trials The drug development process is full of risk, high failure rates, and high costs. DCTs are changing the ways we collect data from patients, and in order to fully embrace the DCT model, technology is critical to successfully manage today’s data needs. A study7 conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) found that there are substantial net benefits for sponsors using DCT technology. Trials using DCT elements led to shorter development pharmoutsourcing.com |

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cycle times, lower clinical trial screen failure rates, and fewer protocol amendments. Screen failures are cost drivers, and although 85% of people state they wish to participate in clinical research, more than 70% live more than two hours away from the study site. As a result, perceived patient burden is associated with screen failures and retention rates, and increases clinical trial timelines. Through a datadriven analysis of the value proposition and return on investment for DCTs using an expected net present value (eNPV) model, they were able to associate monetary values with faster trial timelines.

They found that in Phase II studies, the typical DCT deployment for a clinical trial resulting in a one-to-three-month time savings yielded a net benefit up to five times greater than the upfront investment required, and in Phase III studies, a similar time savings yields a net benefit up to 14 times greater than the upfront investment required.

If we want to realize the full value of DCTs and digital trials, including diversity, it is more important than ever for trial sponsors to ensure their infrastructure is equipped to support this data pipeline. Traditional approaches will no longer be enough to manage the volume of data, let alone provide the insights necessary to make informed decisions throughout the trial. To manage this new level of data flow, clinical research teams need a modern data foundation. In order to bring life-saving therapies to patients faster, we need to reduce drug development cycle times by using time and funds as efficiently and effectively as possible. DCTs are an important and evolving part of that change. By investing in technology that centralizes data into a single source of truth, researchers are able to confidently use data and analytics to realize the value of these growing data streams, react efficiently and measure results.

Measure and Report in Real Time If you’re not collecting and tracking the information that will inform diversity goals, it’s difficult to determine whether there is proper representation or not. One Journal of the American Medical Association (JAMA) report8 found that only 63% of oncology studies between 2008 and 2015 recorded any information about a patients’ race. Researchers need to analyze data that reflects the patient’s age, gender, race and ethnicity throughout the course of the trial, but this requires data that can be accessed in real time. Companies will need a technology platform that can support the volume, variety and velocity of data that comes from modern clinical trials utilizing multiple data streams and system providers. A central platform provides the foundation needed to consolidate data and enable real-time analysis to trial decision-makers. It also helps clinical development collect the data they need to ensure a diverse sample population.

In my role at eClinical Solutions, I see our clients successfully shifting to a cloud-based centralized platform approach and using it as a solution to operationalize their DEI initiatives.9 As part of this, they are monitoring site recruitment and measuring progress against their DEI guidebook. By implementing a technological solution for real-time data infrastructure and analytics, they have found that clinical trial teams could evaluate demographic data for participants and patient populations relative to their global sites throughout the study.

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CLINICAL TRIALS

This insight enables researchers to quickly identify lagging areas in implementing defined elements of their diversity plan. By doing so, clinical research teams can discover areas of concern, discuss solutions earlier in the process, and ultimately, be certain they are achieving diversity in their trials.

Foster the Future of Diverse and Equitable Health Since no two people experience a disease - or a drug - the same way, the industry needs greater inclusion and diversity to confidently evaluate the success and safety of emerging treatments. Participants should represent a variety of lived experiences and environments, in addition to characteristics like race and ethnicity, age, and sex, so that all communities can benefit from scientific advances. Diversity across the industry is key to improving diversity in clinical trials, and it needs to occur from the top down, starting with life sciences companies.

Technology will also play an increasing role - driving better representation in research by helping teams manage the influx of data streams from digital trials and providing real-time measurement.

Together we can ensure that historically excluded communities are given the same access to the medical advancements and life-saving therapies that become the future of healthcare for us all.

References 1.

National Center for Biotechnology. Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. Available at: https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC8652601/. Accessed September 23, 2022.

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2.

ScienceDirect. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Available at: https://www.sciencedirect.com/science/article/pii/S0146280618301889. Accessed September 20, 2022.

3.

U.S. Food & Drug Administration. FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. Available at: https://www.fda.gov/news-events/pressannouncements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinicaltrials. Accessed September 20, 2022.

4.

National Center for Biotechnology. Facial resemblance enhances trust. Available at: https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC1691034/. Accessed September 21, 2022.

5.

ClinicalTrials.gov. Clinical Trial Data Base. Available at https://clinicaltrials.gov/ct2/results ?cond=&term=wearable+device&cntry=&state=&city=&dist=&Search=Search. Accessed September 20, 2022

6.

Intel. AI and Wearables Bring New Data and Analytics to Clinical Trials. Available at: https:// www.intel.com/content/dam/www/public/us/en/documents/solution-briefs/ai-andwearables-bring-new-data-and-analytics-to-clinical-trials-solution-brief.pdf. Accessed September 23, 2022

7.

Clinical Leader. Tufts Finds Substantial Net Benefits to Using Decentralized Trials. Available at: https://www.clinicalleader.com/doc/tufts-finds-substantial-net-benefits-to-usingdecentralized-trials-0001. Accessed September 23, 2022.

8.

Journal of the American Medical Association (JAMA). Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018.

Available at: https://jamanetwork.com/journals/jamaoncology/fullarticle/2748395.

Accessed September 16, 2022.

9.

Clinical Leader. How To Operationalize Diversity In Clinical Trials. Available at: https://www. clinicalleader.com/doc/how-to-operationalize-diversity-in-clinical-trials-0001. Accessed September 21, 2022.

Katrina Rice is Chief Delivery Officer, Data Services at eClinical Solutions, a global provider of digital clinical software and services. She previously held technical roles at Lockheed Martin Energy Group and Bayer. Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven. In her free time, Katrina is member in several organizations including the Healthcare Businesswomen’s Association, Women of Color in Pharma and Chief, a private network for women in senior leadership roles.

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