Beyond the Talk: Addressing the Silent Obstacles to Inclusion

The topic of Diversity, Equity, and Inclusion (DEI) has been at the forefront of many discussions recently, largely due to the pending new iteration of the FDA DEI guidance, significant shifts in the political landscape, and the wave of recent DEI related layoffs across various industries. At the DIA 2024 conference, DEI was a prominent theme, featured approximately in ten dedicated sessions. However, beneath the surface of these discussions, there are four significant challenges that need urgent attention if we are to truly move the needle towards inclusive clinical research that is sustainable.

Insufficient Resourcing and Budget for Robust DEI Strategies

A glaring issue brought to light is the insufficient resourcing and budgeting dedicated to DEI strategies. Many organizations are attempting to manage global DEI initiatives with alarmingly small teams, where some consist of fewer than three people. These under-resourced teams are expected to handle extensive and complex global DEI agendas, which severely limits their effectiveness and scope. Without adequate personnel, the implementation of meaningful DEI strategies becomes an uphill battle.

Moreover, there is a noticeable lack of a defined budget for engaging vendors and sites specifically for DEI recruitment. This financial ambiguity hampers the ability of organizations to attract and retain diverse talent pools. Procurement challenges further exacerbate the situation, as organizations struggle to onboard DEI vendors due to bureaucratic, logistical, and legal hurdles. One such example is measuring community engagement focused vendors on KPIs for patient referral vendors. Many DEI leaders have stated that engagement is required BEFORE trying to talk about referring a patient to a study. These issues collectively contribute to the sluggish progress in advancing DEI initiatives across the board.

Without sufficient resources and budget, even the most well-intentioned DEI strategies can falter. The lack of dedicated funding for DEI activities, training, and outreach efforts means that these initiatives often become sidelined in favor of more immediately pressing business concerns. Additionally, strategies and vendors are brought in as “rescue missions” with limited windows of opportunity but LARGE expectations of turning a highly restrictive clinical program around. These persistent scenarios perpetuate a cycle where DEI remains under-prioritized and under-resourced, thus failing to gain the momentum needed to drive real change.

The objective for community engagement/awareness is not “butts in the seat” rather how many patients are we engaging, what kind of content resonates with them.

DEI Value Not Tied to Business Impact

Another challenge is the prevalent perception of DEI initiatives as purely altruistic endeavors, rather than strategic business imperatives. Yes, ensuring we have a representative patient pool for therapeutic, diagnostic, and device clinical trials is the RIGHT thing to do, however the impact is financially grounded. The messaging around DEI often emphasizes its moral and ethical dimensions, which, while important, can inadvertently undermine its perceived value in a business context. This altruistic framing can lead to DEI being viewed as an optional or secondary concern, rather than a core business strategy.

To shift this perception, organizations need to demonstrate the tangible business impacts of DEI. This involves showcasing how DEI initiatives can positively influence project timelines, lead to significant cost savings, and open new customer pools that can drive higher profit margins. Imagine if companies could increase their customer base by 10-15%, this could lead to millions and sometimes billions in profits. Additionally, highlighting DEI's role in driving scientific discoveries or new therapeutic targets can further reinforce its relevance to business success. By tying DEI efforts to measurable business outcomes, organizations can better justify and sustain their DEI investments.

The integration of DEI into business metrics and performance indicators is crucial. For instance, organizations could track the impact of DEI on employee retention rates, innovation outcomes, and market expansion. By providing concrete data that links DEI efforts to business performance, companies can build a compelling case for the strategic importance of these initiatives. This approach not only secures ongoing investment in DEI but also fosters a culture where diversity and inclusion are seen as integral to business success.

Unknown Consequences for Not Meeting DEI Goals

A pressing concern is the absence of clear consequences for sponsors that fail to meet DEI goals at both regulatory and organizational levels. Currently, there is considerable ambiguity around what happens if pharma sponsors do not achieve their DEI targets – there are discussions around administrative councils and post marketing requirements. Questions arise about the extent to which a sponsor can fall short of their goals and whether such shortfalls should impact the approval of therapies. Without clear consequences, there is no accountability for organizations to prioritize and achieve their objectives. This lack of accountability can lead to complacency and minimal efforts toward meaningful DEI progress.

Establishing well-defined repercussions for failing to meet DEI targets is crucial to ensuring that organizations remain committed to their DEI promises and make tangible strides in this area. Introducing regulatory requirements and enforcement mechanisms could be one solution. Regulatory bodies could establish clear guidelines and penalties for non-compliance with DEI goals, like other compliance standards within the industry. One suggestion would be to have a threshold or cutoff for how far a sponsor can be from their designated DEI goal. The conditions could be (and note will be dependent upon disease/condition):

• If DEI goals are achieved, sponsors can move forward with the next phase / potential approval
• If DEI goal is missed by a small margin, then they must present to the council their rationale; if rationale is not robust then post marketing studies are required
• If DEI goal is not achieved the goal by a large margin, then approval should not be granted until efficacy and safety are shown across the designated subcategories

Persistent Silos Within Industry & Organizations prevent learning DEI lessons

Finally, a significant barrier to advancing DEI is the presence of silos within industry and within organizations. Organizations are hesitant to share lessons learned due to fears of losing a competitive edge and inadvertently providing insights to competitors. Within organizations, teams across different assets or therapeutic areas work within silos which can lead to duplicative efforts. Thus, this lack of transparency stifles collective learning and progress within the industry. When organizations are unwilling to share their DEI strategies and experiences, both successes and failures, it prevents others from learning from these insights and implementing more effective DEI initiatives. A culture of openness and shared learning is essential for driving widespread DEI progress and fostering an environment where best practices can be disseminated and adopted industry wide. One such way of sharing without losing a competitive edge is by participating in consortia where intel is gathered and anonymized in reports shared broadly.

To date some conferences have created sessions for sharing DEI experiences and best practices however the message is too high level, or the sessions are at inconvenient times (e.g., last day, last session). We need more forums designed like Health Equity Congress or Society for Clinical Research Sites (SCRS) to share the granular details about execution and allow the exchange of knowledge. By promoting transparency and collaboration, the industry can accelerate progress toward more inclusive and equitable practices.

Moving Forward

Addressing these hidden challenges requires a multifaceted and collaborative approach. Organizations must allocate sufficient resources and budgets to DEI initiatives, ensuring that dedicated teams have the necessary support to implement robust strategies. It is also essential to clearly tie the value of DEI to business impacts, demonstrating how these efforts can drive financial and operational success. Establishing clear consequences for failing to meet DEI goals will help ensure accountability and sustained commitment to DEI objectives.

Moreover, fostering a culture of transparency and shared learning is crucial. Organizations should be encouraged to openly share their DEI strategies, experiences, and lessons learned, creating a collaborative environment where best practices can thrive. By tackling these issues head-on, the industry can make meaningful strides toward truly inclusive and equitable practices, ultimately benefiting both businesses and the communities they serve.

In conclusion, while DEI is undeniably a critical focus in today's corporate and regulatory landscapes, significant challenges remain hidden beneath the surface. By recognizing and addressing these issues, organizations can move beyond superficial commitments and drive substantive, impactful change in their DEI efforts. This not only enhances business performance but also contributes to a more inclusive and equitable society.

As we move forward, it is imperative that we approach DEI with the seriousness and strategic focus it deserves, ensuring that it remains a central pillar of organizational success and societal progress.