Within the dynamic landscape of clinical trials, the incorporation of Diversity, Equity, and Inclusion (DE+I) into patient pools is frequently driven by moral, ethical, and business considerations. While these are undoubtedly powerful motivators, there’s often an oversight in incorporating DE+I into your clinical trial planning from the onset. In the world of clinical operations, what happens if you don’t plan for an inclusive clinical trial early? Below we’ve outlined key considerations for why you need to incorporate DE+I into clinical trials sooner rather than later.  

Top 3 Reasons Why You Need to Incorporate DE+I into Clinical Trials Today 

1. Considering the Business Advantage 

There are substantial business advantages for thinking through DE+I considerations before a clinical trial even begins. Rather than adapting strategies while in the midst of an expensive trial, firms should plan far ahead of time to ensure that DE+I is considered when thinking through budgets, communications, critical KPIs, and more. 

A lack of diversity in clinical trials can have severe effects upon revenue once at market. Many demographics may feel uncomfortable taking drugs that have not been properly screened for their genetic or ethnic background. Carbamazepine, for example, was found to cause a severe skin disorder in some patients of Asian heritage. Consequently, even if a drug isn’t pulled from the market, it may not meet revenue targets as patients decide against drugs unproven in a diverse trial pool. 

In a worst-case scenario, a treatment that has not properly incorporated DE+I in clinical trials can be pulled from the market for concerns of harming certain populations. Tangibly, the immense cost of bringing a drug to market will have been for naught as all revenue is put on hold. Intangibly, a firm’s reputation will also suffer, which can even more severely degrade profitability. Other current and future drugs produced by the firm may be faced with skepticism, and thus fall short of revenue targets, too. 

Protecting the bottom line and a firm’s reputation are incentive enough to plan for DE+I now before a trial even begins. Rather than scrambling to adapt strategies mid-trial, firms should plan and budget far ahead of time. Demonstrated success with a diverse group during trial will likely lead to a more successful result as the product goes to market.  

2. Building Participant Trust 

Incorporating DE+I initiatives into clinical trials isn’t a task that can be accomplished overnight. Part of the importance of planning for DE+I long before trial kickoff is that trust must be built within diverse populations early. Oftentimes, however, individuals have distrust for clinical trials due to historical involuntary commitment and mismanagement.  

One strategy that firms can use to bridge the gap early is connecting with community leaders and organizations that are already trusted. For example, connecting with a local religious center can establish credibility and help patients feel safer. It’s vital, however, for trial researchers to also be diverse so that they can have insights into a culture that would otherwise be overlooked. Whether this means that they speak the language or are themselves from the culture, it’s crucial for researchers to understand and be able to relate to the patients who may participate. 

An additional strategy that requires firms to plan far in advance is to work with patient advocacy groups. These organizations help firms better understand the needs of unique communities and bridge the gap between patients and researchers. Essentially serving as allies for the patients, they often provide educational materials and support before and throughout the process. 

Ultimately, building patient trust so that they feel comfortable participating in a clinical trial is a process that requires foresight. Incorporating DE+I into a clinical trial may hinge upon patient groups feeling safe enough. Consequently, firms must include strategies and budget accordingly now so that they have willing participant pools when the trial arrives. 

3. Keeping Pace with the Changing Landscape of Clinical Trials 

Establishing DE+I as a priority when planning clinical trials is essential for aligning with dynamic industry shifts. A growing number of pharmaceutical companies are adopting new strategies for reaching a larger, more diverse group of patients. To stay competitive in the market, pharmaceutical companies that haven’t yet made DE+I planning a priority must take swift action to not fall behind as the clinical trial landscape constantly transforms.  

Clinical trials are increasingly adopting decentralized models, moving away from the traditional reliance on academic and medical institutions as trial sites. This non-traditional framework allows pharmaceutical companies to meet patients where they are by utilizing remote elements such as home technology. A more diverse patient population can participate in a clinical trial that is able to be conducted remotely, such as from the patient’s home via wearables or video conferencing. 

Frontier sites can also advance clinical research by operating trials at more community accessible locations, such as local pharmacies or clinics. For example, Walgreens has announced a commitment to continue as an active site for accessible clinical trials. Patients who face challenges commuting to city-based institutions now have greater opportunities to participate in clinical trials. This expansion broadens the diversity of the patient base, leading to more comprehensive and inclusive results. 

Pharmaceutical companies are also placing a growing emphasis on staff education to foster a greater level of support for DE+I throughout the trial planning and execution processes. Cultural competency trainings offer an opportunity to improve cross-cultural communication between patients and staff, which can lead to improved patient enrollment and retention rates. Educating clinicians can create a stronger relationship between minority patients and the drug industry, and it’s imperative for all organizations to display this commitment. 

Looking Ahead 

To create diverse, highly trusted clinical trials, clinical operation teams must make DE+I strategies a priority in the initial planning stages. Low diversity within your patient base not only limits revenue potential, but also puts your company’s reputation and relationship with minority populations at risk. 

Integrating DE+I initiatives into your budget, trial strategy, and communication plans is imperative for staying in line with shifting industry regulations and growing patient expectations. Focusing on inclusivity can foster trust and form strong community partnerships, increasing the profitability and the positive reception of the product upon trial completion. It’s more critical than ever to implement DE+I strategies to establish a successful and profitable clinical research organization. 

To learn more about how to incorporate DE+I strategies into your clinical research from the start, contact Clarkston’s Clinical Research experts today.  

Contributions from Jake Park-Walters and Sam Weitzel