Mar 29, 2023

Four Key Actions to Operationalizing Your Diversity Action Plan: Learnings from Leading Clinical Research Leaders

We are fortunate to be in an industry where experienced leaders often come together at industry conferences and events to share insights and learnings with others to advance clinical research and ultimately improve health outcomes. My most recent experience at the Health Equity Congress in Boston, MA did not disappoint. For two days, diversity in clinical trial leaders from around the world convened in wintry Boston, undeterred by ice and snow, to collaborate, reconnect and advance health equity for patients who need it most. The nimble forum provided the perfect backdrop for meaningful, poignant collaborations. This experience was a stark departure from the frenetic harried pace of some of the larger conferences. As the meeting continues to grow in popularity, I hope the spirit of collective impact remains. It was a great forum where large companies shared best practices, with smaller organizations sharing their agile approaches to bringing these action plans to life. If you are seeking to implement diversity action plan development and deployment at your organization, here are four key actions that I learned from seasoned leaders.

Clear Accountability - One thing that came across clearly was that there wasn’t a one size fits all approach to how diversity plans develop. In some organizations, the medical writing team was responsible for crafting the diversity action plan document with feedback and input from the diversity in clinical trials and clinical operations leaders. In other organizations, the reverse approach was taken with the diversity in clinical trial leaders and the clinical operations leaders developing and writing the plan. The one thing that was clear across every organization was the clarity of accountability for executing the plan. For several organizations, the execution responsibility ultimately sits within clinical operations and clinical development as a best practice to ensure the implementation of the strategies. Therefore, sponsor organizations must designate a study lead and department responsible for operationalizing the plan.

Alignment - Internal alignment is mission-critical to operationalizing these plans. Executive alignment as to the importance of having more representative trials along with the regulatory requirements is imperative to ensuring sufficient resources are aligned. Organizations need alignment on components of the plan they can perform in-house vs. aspects of the plan requiring partners and vendors to help them deploy.
For example, must they retain an external epidemiologist to support benchmarking efforts?
Is there alignment on partners required to deploy the plans- Community awareness vendors, Community Site Partners/IROs, Patient Recruitment, DCT, technology, CROs
Can R&D and Commercial teams align on diverse patient outcomes and objectives to maximize ROI and potentially shared resources inclusive of data?

Start Now - This came across loud and clear from FDA agency representatives and industry leaders. The time to submit your plans is now before the finalized guidelines. Leverage this grace period to your advantage, as the current submissions can help inform the future state and process. Leverage the data that is currently available to benchmark incidence and prevalence. It is not enough to say it doesn’t exist and allow that to deter your efforts. Suppose the current data is limited. Use what you can from registry resources. In that case, epidemiologists, EMRs, claims data, and cross-reference with social determinants of health and what is known about the condition and IP to inform your action plan. Furthermore, to rectify some of the inherent challenges and biases currently in data sets due to omissions of the representative population in the machine learning models, we can only overcome them by gathering more equitable data.

Track Progress & Collaborate - These plans are living and breathing documents to help inform how to best collaborate with diverse patient populations. Moreover, these plans lend themselves to supporting enhanced collaborations across the industry and sponsors to drive more innovation in developing safe and effective medicines for patients needing them most. Teams must consistently measure what’s working and, more importantly, what’s not to pivot.

The time is now to prepare teams for the guidelines. With that in mind, the four key actions can guide the establishment of accountability to ensure someone(s) is leading the charge and change. Second, teams should prepare everyone for the need to adapt policies and procedures to align when the time is right to make changes. And lastly, this will set up your team to track progress and collaborate with others so that, as an industry, we continually learn and devise even better solutions.

Written by Ryan Brown, VP Diversity Solutions, Circuit Clinical