Three steps to improve and measure your clinical trial patient diversity efforts

Over the last several years, the life sciences industry has contributed to an increased investment of time, funding, and energy in initiatives to improve the diversity of clinical trial participants. This increase in investment supports an already understood logic: that a properly diverse pool of clinical trial participants delivers the most representative set of insights regarding the safety and efficacy of a therapeutic solution. Despite this knowledge, organizations are often faced with the challenge of determining the type and level of diversity needed for clinical programs and individual studies. This is largely because diversity is an umbrella term that covers a range of characteristics including diversity of age, racial and ethnic makeup, socioeconomic status, and sex. Successfully overcoming this challenge then leads organizations to an even more daunting one: accurately measuring the performance and impact of diversity efforts toward their goals and objectives. In other words, they need to generate the appropriate evidence to demonstrate progress and improvement in this space. Even with the increase in investment, clinical teams are unclear on how to develop an optimal set of metrics to measure the success of diversity initiatives within clinical research.

In this piece, we discuss how life sciences companies can position themselves to successfully execute and measure the impact of diversity improvement initiatives within clinical trials, with insights on:

1. How to set a strategic vision for a diversity initiative that aligns with your corporate goals,
2. Best practices for creating KPIs applicable to diversity efforts, and
3. Building a culture of continuous improvement and adaptability to ensure the initiatives meet their full potential.

1. Crafting a compelling business case

Diversity initiatives, like other areas of spend, require a compelling business case to gain the proper level of support and buy-in from leadership. Diversity initiatives require sizable investments of time, money, and effort, with the expectation they will perform and succeed while facing complex, costly realities of clinical trial recruitment (i.e., difficulty engaging communities and a lack of retention). When drafting a strong business case and strategy for clinical trial diversity initiatives, there are some key messages that business leadership and the program team need to align on:

• Define the diversity context. The proposed initiative needs a what and a why this is important for a specific therapeutic product — this is an imperative for an initiative to be successful. While we can break down diversity into the classic parameters of sex, gender, age, race, ethnicity, income, etc., the business plan must articulate the clinical and business benefits of understanding the outcomes and effectiveness among these diverse groups. A good place to begin in defining the common goals and diversity markers is reviewing recent publications by regulators (e.g., FDA’s draft guidance on diversity).
• Tie the business model to ethical imperatives. Oftentimes, new and experienced leaders of diversity initiatives can quickly find themselves managing haphazard engagements that have difficulty demonstrating the expected business value (e.g., ROI, patient or community retention, and engagement). In these moments, the business plan can benefit from a second recommendation, ensuring a clear link to the strategic vision of a business unit and its leadership. The trial results data gathered from trials with adequately diverse populations can influence marketing and messaging, as well as the sales footprint in specific geographies and thereby impacting the commercial capabilities of the business unit. For example, a goal as part of the diversity initiative can be to recruit the most representative populations based on prevalence data of the disease being treated. This can result in outcomes such as greater product differentiation and/or broader label claims that reflect the benefits and risks to a wider range of patients. In turn, this can manifest as an improved business value in the form of positive financial return from product commercialization and, further, may be ideal for value-based care types of agreements as products that demonstrate clear efficacy within a representative patient population show better clinical outcomes.
• Prioritize a culture shift. A diversity initiative requires a culture shift by the teams responsible for carrying it out. Stakeholders responsible for driving the diversity initiative forward should foster internal ways of working that welcome diversity of thought and experiences. The teams should have multiple opportunities to interact with new perspectives and engage communities with various demographic differences. On the engagement side, an initiative’s vision should try to tie to objectives related to building trusted relationships in localities. One of the best ways to do this is to build advocacy among trusted individuals and establishments in the community. This can include partnering with verified and respected nonprofits, community health organizations, religious institutions, or healthcare associations that have experience interacting with specific groups. These organizations create a critical link between the life sciences organization and the community and may be key sources for measuring and validating diversity initiative performance and effectiveness.

2. Creating applicable performance indicators

Once the vision and objectives for a diversity initiative are established, teams should pivot to defining performance metrics, or key performance indicators (KPIs), to help both leadership and delivery teams understand progress toward the vision in a tangible way. The creation of KPIs for diversity initiatives requires a different approach from what you might take to measure a drug’s commercial success. Rather, it is an approach to better understand and address the safety and efficacy of the drug being studied, especially in populations most impacted by the condition or disease.

When creating KPIs for a diversity initiative, teams should take into consideration the categories of KPIs that align most closely with measuring performance against the set vision. For example, using a mix of quantitative and qualitative KPIs can uniquely contribute to understanding the true impact of an initiative’s efforts. To help illustrate this, a diversity initiative may have objectives tied to clinical trial performance (i.e., enrollment rates, retention rates, etc.). To track the impact and performance for these types of objectives, traditional clinical trial KPI measurements should be reconsidered in the context of diversity. For instance:

• Time from prescreening to consent. Patients of diverse backgrounds can be clinical trial-naïve or mistrusting, given the pharma industry’s mixed history. A valuable KPI for capturing and understanding the impact of these types of factors can be the average time from prescreening to consenting. By segmenting patient groups and controlling for certain variables, one can compare the results of the same process for both diverse and non-diverse participants. This can help to reveal inefficiencies or additional steps in the process (i.e., education, awareness) that might be required, thereby informing future enrollment strategies.
• Screen failures. Expanding data capture for screen failures to include the reason for failure (e.g., decision not to participate) and associated rationale can provide important insights into the thoughts or behaviors of diverse participants not previously understood. Further understanding this impact on clinical trials and in the context of a specific diversity initiative can help to provide important insights behind performance.
• Trial retention. Analyzing patient dropouts for patterns across demographic data such as race, ethnicity, orientation, age, and more can reveal potential biases in your clinical study design. It’s important to understand whether the design of the trial supports sustainable participation from all enrolled participants.

Assessing performance through KPI measurements like the above can provide important insight into the progress and impact of actions taken as part of a diversity initiative. Over time, the increased availability of this data creates possibilities for more detailed analysis, including trends across studies, programs, or therapeutic areas.

3. Building a culture of accountability

With the vision, goals, and KPIs in place, a final and critical step is to build a sustainable culture of accountability. A plan for accountability, fortified with continuous improvement and open-mindedness for change, is instrumental in creating lasting impacts as compared to a one and done approach. A one-time, check-the-box approach to improving diversity in clinical trials may show short-term results but will likely fail in creating systemic change within an organization.

A great example of this is the response to the FDA’s draft guidance on diversity. Released in April 2022, the FDA guidance for sponsors of clinical trials includes a diversity plan to explain how diversity targets were derived and what the plans are to achieve them. While some organizations envisioned this type of guidance, not everyone had resources and procedures in place to fulfill this new expectation from the FDA. So, organizations are trying to meet the FDA’s minimum ask in the short term. And even though this may lead to a success (i.e., reaching trial diversity targets), it must be recognized that diversity isn’t a one-time exercise. It’s a repeatable set of actions and activities that are only sustainable through a shift in cultural mindset. While organizations have made strides toward this, it is an area within industry that requires continuous improvement. The overall goal is for the efforts and actions of diversity improvement initiatives to naturally become part of business as usual, which a mindset of accountability can help achieve.

Adoption of accountability is certainly easier said than done and should be thought about as a continuous improvement process. Time to adoption, the number of improvements incorporated, and other actions can all vary. Being open to both new and old methods of adoption can be a great starting point to bring together all ranks, departments, and even therapeutic areas to march in sync. A few methods to create a culture of accountability include:

• Use existing culture as an asset. Accountability does not necessarily require an overhaul of the company’s current culture. For example, leveraging an organization’s existing culture of giving back to the community by infusing new objectives and rewards related to diversity can be a natural way to take advantage of an established way of thinking, group of people, etc., without being disruptive.
• Set strong goals. An accountability plan is only as good as its goals. Setting out strong goals from the start highlights expectations for team members to be held accountable against. The goals should be achievable and progressively build on one another to incentivize continued participation. Setting goals incrementally may also be advantageous to show progress and keep team morale high.
• Create a training plan. In parallel to setting goals, putting a plan in place to provide training on the importance of incorporating diversity as a culture can be beneficial. Trainings can set a foundation and shared vision of the ideal future-state. Trainings also can be used as an opportunity to communicate the organization’s plan to work as a unit and as a plan to hold teams accountable should they veer off the path.
• Measure progress and iterate. A culture of accountability will be an iterative process. It is beneficial to monitor the outcomes and adjust objectives and timelines as needed accordingly. Starting small and applying the change in select departments/therapeutic area teams can provide meaningful insights and thus opportunities to apply those learnings and adjust the process for other teams.

Clinical trials have seen a significant shift toward improving the representation of diverse populations. Prior to this change, patient populations utilizing approved medications were often not represented in clinical trials, leading to a reality where potential side effects and adverse reactions were not studied in the intended populations. While this shift can seem challenging to achieve, it is attainable and there are concrete steps that can be taken to get started and create a lasting effect. And although aligning on a vision, measuring progress, and creating a culture of accountability doesn’t happen overnight, it is imperative that we keep pushing forward. The more we work together to put this in place, the more this becomes the standard.

This article was first published in Clinical Leader