Building Inclusive Science: The Vital Role of Diversity, Equity and Inclusion in Clinical Research

Diversity, equity and inclusion (DEI) have become important elements in the landscape of clinical research. It is important for the principles of DEI to be understood for their goals, intended outcomes and applications; otherwise, they may be regarded as mere buzzwords or just another box to tick on organizational mandates.

DEI are critical components of building a thriving, fair, all-encompassing, respectful and innovative society. By understanding and actively promoting DEI, individuals and organizations can help create environments where everyone has the opportunity to succeed regardless of their background or identity by overcoming and dismantling systemic discriminatory barriers.

Implementing DEI principles is not without challenges. It requires ongoing commitment, education and sometimes difficult conversations. There can be resistance to change, and it may take time to dismantle long-standing biases and systemic barriers.

Building DEI within life science organizations, particularly in the area of clinical research, is not just a social imperative but also a scientific one, ensuring that drugs developed are both safe and effective for the populations they are intended to serve.

Xtalks spoke with Stacy Weil, DHI, Senior Vice President, Business Operations and Patient Centricity, Premier Research, to gain insights into incorporating DEI practices and plans in clinical research.

XTALKS CLINICAL EDGE: Issue 3 — Premier Research Interview

Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.

The Scientific and Social Imperatives

In clinical research, DEI planning holds dual significance. One is the scientific aspect because a given treatment should be developed in the population that it’s intended for, explains Weil. This entails designing clinical trials that involve recruitment of appropriate populations to ensure the trial data is reflective of the population(s) that will ultimately use the drug.

There is also a social aspect to DEI plans rooted in health equity and access to care. “From a health equity perspective and access to care, the intent is that people have equal opportunity to participate in a clinical trial,” says Weil.

This dual focus can, however, introduce challenges. Balancing the scientific need for diverse datasets with the social need for inclusivity requires careful planning and execution.

Navigating FDA Guidance and Legal Considerations

In June, the US Food and Drug Administration (FDA) updated draft guidance on diversity action plans required for certain clinical studies. The agency said diversity action plans are “intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product.”

The FDA emphasizes that enhancing diversity within clinical studies not only facilitates broader applicability of results across a broad spectrum of patient populations, but also enhances understanding of the disease or medical product under study. The ultimate goal is to extract insights that will help inform the safe and effective use of the medical product among patients.

Weil explains that the responsibility of creating and implementing an equity plan for an asset’s entire development process falls on the sponsor company.

Weil explains that while a clinical research organization (CRO) like Premier Research may manage individual clinical trials, its operations or clinical teams would not necessarily be charged with the development of a DEI plan. The sponsor company would submit the plan, which the CRO would use to build a recruitment and engagement strategy.

A critical consideration, which can often get lost in the mix, is that as per the FDA’s most recent draft guidance, the plan is most applicable to Phase III studies, or other pivotal studies as applicable. This plan must be in place well before Phase III trials begin, as the FDA requires it to be reviewed and approved prior to patient enrollment in the Phase III trial.

The Importance of Early Planning

Early planning is critical to the development of DEI strategies. While it may appear to be particularly challenging, with advancements in precision medicine, the availability of genetic data and the application of AI tools, it could be possible to predict how a drug might perform in different populations early in the development process. This can enable the selection of molecular targets and, in turn, patient populations, early on in development.

“If I were a biotech client, knowing the expectations of the FDA guidance and the information from preclinical research, I would start to have a plan very early on,” says Weil.

How early is the question. In its latest draft guidance, the FDA specifies that the client should submit the plan to the FDA with enough time for the agency to review the plan and send it back with comments before the first patient is enrolled in Phase III.

Compared to the original guidance, the latest draft has provisions that acknowledge a diversity action plan may not apply to all trials, which is helpful as pertaining to feasibility, explains Weil. This includes considerations such as whether certain ethnicities or racial groups are afflicted by certain diseases in the same proportion as others, and if so, should the focus be on the groups afflicted “most” by the disease in order to have better, more reflective and relevant data. At this time the provision is open to interpretation which has created some hesitancy in moving forward with developing a formal plan.

Waiting until later phases to develop a DEI plan can be risky, as it might not leave enough time for necessary adjustments. Weil recommends beginning the planning process as early as Phase II to ensure that the plan and subsequent recruitment process can be thoroughly reviewed and refined before Phase III trials commence. “The farther in advance you can plan that, I think the better,” she says. Optimally, the plan should be a part of the Investigational New Drug (IND) submission, she adds.

Beginning to work on plans even at the preclinical stage would not be unusual, as companies may have some idea scientifically at that point as to how a treatment may work in certain populations. If you have good indications at this stage, Weil recommends starting DEI planning at that point in time as that will give you plenty of time to get the plan prepared. “You can adapt it along the way as you’re conducting your trial. You can get it to the FDA for review long before Phase III because there is an obligation to return it, and have that back and forth [with the agency] within a certain period of time,” she explains.

By the time you get to Phase III, a lot of lessons would have been learned with startup, Phase I and Phase II, which may enable things to go a little bit smoother and faster, and systems could be built a bit quicker, she says.

Key Components and Considerations of a DEI Plan

To build a DEI plan, there are several important elements and considerations. These include identifying a plan in the overall development strategy and operationalizing the strategy through the recruitment and retention plan. Another critical piece is data collection in terms of how data will be collected in support of whether key points in the plan are met or not and then ensuring the statistical analysis plan includes provisions for the proper analysis of the data in accordance with the results within the population recruited into the trial.

While the FDA’s DEI guidance is primarily focused on the US, many clinical trials are multi-center with sites across the globe, which introduces added complexities. Different countries have varying regulations on the collection of race and ethnicity data and potential differences in how race and ethnicity are specified.

Data collection methods may also differ across regions and countries. The FDA guidelines outline US standards, but the way race and ethnicity data are collected in the US may not be applicable in other countries.

Ensuring uniformity and consistency across sites also extends to the design and use of databases in clinical trials. Companies must ensure that their systems can adapt to the different ways countries recognize patient characteristics.

Previously, databases were not built to include a DEI plan. In the US, since the plan is slated to become a requirement, building a database for collecting data as per US guidelines may not translate to other countries in a global study, which can complicate the process of creating a unified plan.

Databases should be set up to give options for turning fields on and off, depending on applicability based on region and country which help to safeguard teams from inadvertently collecting data that they shouldn’t, Weil says. If all fields related to race and ethnicity in a database are made available, for example, people might collect data and enter it into the database, which could inadvertently go against data collection regulations in a given country. This introduces complexities into DEI planning and execution, necessitating early planning and consultation with all stakeholders involved, including the FDA and sites.

The opportunities presented by embracing DEI are significant. By fostering diverse, equitable and inclusive environments, organizations and communities can unlock the full potential of their members and drive innovation.

As the landscape of clinical research continues to evolve, the integration of DEI into the trial process is not just a regulatory requirement but one that is grounded in scientific and ethical principles. Companies must prioritize the development of comprehensive DEI plans early in the drug development process, ensuring they are prepared to navigate the complexities of both US and global regulations.

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