t is a fundamental principle of drug development for sponsors to understand who is likely to use their product to manage their disease or condition. To ensure that clinical trials accurately represent the population who will potentially use the products once approved, we have to change how we work.

Some people consider improving clinical trial representation to be an expensive and time-consuming effort. But some sponsors have learned that planning for representative clinical trials early in the study design cycle is actually very efficient.

First, this requires a change management approach. This means revising SOPs or templates for organizations that are just getting started in drug development, and more formal change management for large organizations. Bringing in outside experts to look at your processes and policies and assess your clinical trial operations can be helpful. If this proves to be a tough sell to your leadership, identify and interview companies that are already on the second iteration of this process; many sponsors have rethought their approach and started all over again, incorporating change management the second time around.

You do not have to wait until change management is fully incorporated. Simply taking these actions can support your efforts immediately:

• Reality Check: To identify unforeseen barriers to true representativeness in the study, pressure-test the protocol with patients, patient advocates, and the community; review and assess the eligibility criteria, visit windows, and study design for participant burden. Sponsors should review FDA guidance to Enhance Clinical Trial Diversity before finalizing the protocol. Bring in a diversity expert early during protocol development who can objectively pressure-test your protocol to identify any unintentional barriers so that they can be removed. This means talking to patients and asking them to identify barriers in the protocol. A patient may notice, for example, that the protocol requires them to travel a long distance for simple blood draws that could be done at a local laboratory or hospital.
• Get Help with Site Feasibility: After pressure-testing your protocol, it’s time to work on feasibility. It’s true that you need to figure out which sites are going to work for you in reaching people who have been previously underrepresented. Diversity experts can help you identify, through area demographics, which sites can help you reach the people you need for your study. These could be contracted suppliers or internal subject matter experts (SMEs) who understand the demographics, culture, and other important nuances of the local community/geography. Work with suppliers who can identify sites that can recruit patients appropriate for the study. Assess sites for practices in recruiting underrepresented groups and determine whether sites should implement implicit bias training to improve these practices.
• Helpful Reminders: Remind sites to consider all potential participants who may be eligible for the study regardless of demographics, occupation, income, language, and ability or disability.
• Engage with Communities: Ensure that you engage with communities. Identify studies of interest to communities and then take these studies to where these people are; engage with trusted community-based organizations, ideally months and even years before recruiting for a study. This builds sustainable trust in your organization and your goals. Work with people whose role is to build relationships in the community. It is essential to build grassroots-level relationships with trusted community-based organizations such as churches. This cannot be stressed enough: The most impactful level of advocacy is grassroots: meeting people in their own communities. Changing the mindset around clinical trials to recruit all populations in the community creates a much better chance of recruiting a more diverse set of people into your study.

The authors have worked in both the clinical and commercial sides of these relationships, and the above steps have consistently worked in connecting communities to care. Taking these proven steps to enhance diversity in clinical trials will initially mean adjusting and learning. In the end, though, these steps will help reach many potentially eligible participants and enhance clinical trial participation for everyone; in time, they will become second nature in relationship building that is respectful and sustained.