Breaking down barriers to participation in clinical research has long been a challenge, affecting every aspect of the industry. As the industry works toward a more cohesive, diverse, and inclusive environment for all, Advarra’s mission is to invest in understanding and educating the industry on this critical topic. Developing a more inclusive and equitable study and research environment will reap many benefits for the industry and establishes the precedent for future trials as we work toward a more inclusive environment for all.
However, figuring out where to address barriers and create a more inclusive environment is overwhelming. This blog aims to define diversity, equity, and inclusion (DEI), discuss exclusive trends in recruitment and trial design, and present actionable steps sites can take immediately.
When researchers address the lack of diversity in clinical research and work to improve upon it in their current practice, a common mistake made is not understanding the nuances of DEI efforts, and looking at each concept as a separate entity, rather than understanding how they intertwine. While DEI is made up of individual concepts, every concept is needed to support one another, and it’s common for researchers to focus on one or two concepts, rather than all three simultaneously. To further understand how to achieve DEI in research, each concept needs to be defined as such:
- Diversity: making sure everyone is represented
- Equity: being fair to anyone involved
- Inclusion: creating an appropriate environment for all involved
Many researchers attempt to solve the symptoms of the problem, when in reality, addressing the root cause – which is most often tied to a lack of equity – will allow research staff to address and work toward solving DEI-related challenges the industry faces today.
Effectively Recruiting Participants
Throughout the industry, recruitment proves to be a major roadblock at any stage of a protocol. Without the necessary amount of participants enrolled in any study, startup delays, ultimately costing researchers time and money. Each protocol must have appropriate inclusion and exclusion criteria; however, researchers still focus on populations most convenient to them and do not evaluate criteria critically for each study. This practice enables researchers to seek out populations they are familiar working with and neglects certain populations because of criteria denying them participation in a trial.
Actionable Steps to Take
Since racism is not individual, it must be addressed at a systemic and structural level. If researchers want to solve recruitment problems for their studies, they need to look at the system as a whole and improve and build upon the current infrastructure. If teams are unsure where to start, these common barriers may be the first place to look at and examine.
Communication is paramount for success, including the clinical research industry. If researchers are not effectively communicating their trials to seek out participants, whether that is through physicians, community leaders, or other forms of advertising, then they will lose out on obtaining a diverse participant population.
An easy way to ensure better communication is to create an action plan moving forward. Build workflows into patient visits so potential participants know there are trials available to them. Understand how staff communicates to participants during visits – both online and in person. Are researchers meeting their participants where they’re at in terms of the language they can understand? Are participants coming in for necessary visits, and participating in remote capabilities as well? Consider these as the action plan is formulated and built.
Oftentimes, people will choose to participate in a trial if they know they can trust the process. Building relationships with external stakeholders, such as community leaders, their own providers, or word-of-mouth referrals benefits everyone. It gives researchers an opportunity to spread awareness about a trial, it gives stakeholders the opportunity to help others seek treatment, and it helps potential participants feel reassured if it’s coming from a trusted source.
Building trust isn’t something research teams should rely on with just external stakeholders; trust needs to be maintained after a participant agrees to take part in the trial. For example, including a diverse staff team who may have a better understanding of participants’ backgrounds, allowing them to advocate for them. This effort will greatly aid in establishing trust, recruiting potential participants, and retaining them as the protocol moves throughout each phase.
Effectively Design a Trial
Many times, staff get into the “copy/paste” habit when designing a trial. This is normally done in an attempt to save time by transferring the same requirements from one protocol to the next, especially when dictating the trial’s inclusion and exclusion criteria. This method is a direct symptom of a staff’s heavy bandwidth, but in reality, every trial needs to be designed individually as each trial is unique from the rest.
Additionally, as humans design trials, we need to acknowledge our own implicit biases at work when creating one. As a trial is shaped, taking extra time to review and understand where an individual’s biases may have impacted the design can greatly minimize the risk of creating a non-inclusive trial. As we work together to create a more inclusive and equitable research environment, it’s important to understand this process will require intentional and continual learning and unlearning from everyone involved.