Improving Diversity and Inclusion in Clinical Trials

Promoting greater inclusivity among clinical trial participants plays a pivotal role in addressing healthcare inequalities and fostering equal access to healthcare. To further our understanding of treatments and vaccines, it’s crucial that those taking part in trials mirror the disease’s prevalence in various demographics and accurately represent relevant clinical populations. 

Increasing clinical trial diversity and reducing demographic disparities is key to achieving this. In this guide, we explore methods for improving diversity and inclusion in clinical research.

Diversity Challenges and Disparities in Clinical Trials

The development of most new treatments typically involves a sequence of clinical trials, taking place across three phases (phase I, II and III). Among these, phase III studies are the most advanced, and are tailored to evaluate a drug’s safety and efficacy across a broader population than previous phases. 

Ideally, phase III studies should encompass a diverse range of participants, in particular the demographics that the drug is intended for. This is to ensure that the drug’s efficacy and safety profile can be accurately assessed across various population groups, helping to inform its performance not only in clinical trials but also in real-world scenarios. 

Additionally, a diverse study population can provide valuable insights into any potential variations in response to the treatment among different demographic segments. For instance, age, gender, and underlying health conditions, which can be crucial for tailoring the drug’s marketing and content strategies effectively.

Given that certain diseases disproportionately affect specific demographic segments, such as specific ethnic communities, regulatory bodies have begun to establish explicit requirements for achieving diversity in clinical trials.

Ultimately, striving to improve diversity and inclusion in clinical trials and other healthcare settings means that progress can be made to ensure everyone has equal access to the medical care they need.

Unfortunately, many trials fall short in achieving a diverse participant pool.

How CROs and Sponsors Benefit From Inclusion and Diversity

End-users from different demographics aren’t the only ones who stand to benefit from clinical trials being more inclusive and diverse. CRO’s and teams carrying out clinical trials benefit from the increased sample size of people to recruit, which ensures they can hit their recruitment targets.

Hitting recruitment targets on time means that there are little to no delays, which can save a clinical trial’s sponsors a substantial amount of money. Not only that, but a larger number of participants also means that the trial generates more data, leading to more accurate results.

Factors That Contribute to Poor Diversity and Inclusion in Clinical Trials

Medical Provider Bias

Some healthcare professionals may unknowingly hold biases that influence their interactions with patients, resulting in differential treatment and ultimately poorer health outcomes for minority patients. Some healthcare providers may also lack awareness of or sensitivity to the cultural norms and values of minority groups, making it challenging to build trust.

In addition to this, clinical trials can be set up excluding certain minorities, which can lead to less thorough testing of the drug within those specific demographic groups. This has the potential to lead to adverse effects of the drug in relation to particular genetics that stem from the ancestry of different minorities.

Language Barriers

Language barriers can further complicate communication in clinical research, making it difficult for patients to discuss their medical conditions and treatments. This can lead to misunderstandings about the significance of research and mistrust during the recruitment process.

In addition to this, a lack of clear communication can result in clinical trial participants having a lack of understanding about the trial process, which can result in increasing site burden for them. An increase in site burden has the potential to lower the retention rate of participants within clinical trials, which can massively impact the success of the trial overall.

Limited Access to Healthcare

Limited access to healthcare facilities and services in minority communities, often due to economic factors, contributes to the lack of inclusivity in clinical trials. The challenges faced by individuals who work during traditional business hours and rely on public transportation, make it difficult for them to participate in clinical trials. 

Additionally, insufficient access to basic clinical care may mean that individuals are not informed about available clinical trials, which can further increase the disparity within clinical research.

Distrust for Healthcare Settings

Healthcare systems can have built some distrust with individuals within minority communities, whether it’s because of historical events or based on bad personal experiences.

As mentioned i above, a lack of inclusion within clinical trials can mean a drug isn’t fully tested within certain demographics, which can only further perpetuate the cycle of distrust if a needed drug is revealed to have adverse effects. Combatting any distrust and building positive relationships is key.

How to Improve Diversity and Inclusion in Clinical Trials

Diversity and Inclusion Research

One of the strategies that can be used to start improving diversity and inclusion in clinical trials is for CROs to start defining the groups most susceptible to the disease being studied.  This can be achieved through epidemiological research and recognising what obstacles are currently present which stop people from different demographics accessing high-quality healthcare. These obstacles are commonly referred to as ‘disease burden’.

Communication and Trust

Sponsors must engage in communication and collaboration with the community to establish a mutual understanding regarding the significance of volunteers participating in clinical trials. Furthermore, sponsors should pledge to maintain transparency throughout the entire process, helping participants understand the trial design, desired outcomes, and the disclosure of trial results. 

Additionally, sponsors should actively seek input on design elements that could affect community members’ ability to take part in these trials.

Expand Recruitment Outlets

Expanding patient recruitment efforts can involve tapping into independent disease registries and patient advocacy groups. Additionally, a proactive strategy is to broaden the search for potential participants beyond academic medical centres. This can encompass reaching out to local health systems, collaborating with community organisations, and even utilising direct-to-consumer channels through social media and traditional media outlets.

Developing Diverse Teams

In the realm of clinical trials, racially and ethnically diverse investigators and staff who mirror the communities they serve play a pivotal role as community ambassadors. They contribute significantly to the cultural competence of trials and serve as a safeguard against unconscious or implicit bias.

On top of this, providing training and support to personnel and research partners to both effectively recruit diverse participant populations for clinical studies, and educate existing staff on how clinical trial teams can become more inclusive and diverse in their approach.

Improve The Platforms Used

To establish a sustainable foundation, it is crucial to offer ongoing support and implement standardised platforms. Developing a robust data infrastructure that harnesses real-world data can greatly assist investigators in identifying and connecting with eligible patients for clinical trials. This infrastructure should also encompass baseline measurements to enhance the quality of data related to race and ethnicity.

The Role of CRO Services in Achieving Diversity and Inclusion Goals

Working with the right CRO service provider can be a good way to help improve diversity and inclusion in your clinical trials. Their expertise in helping conduct clinical trials for their clients means they should have plenty of experience in doing so, and therefore should have an excellent understanding of regulation guidelines.

To ensure diversity in clinical trials, sponsors should consider the following factors when selecting a CRO:

Global Site Network

Confirm the CRO’s global presence and their commitment to leveraging this network for diverse participant recruitment. Inquire about their access to epidemiological and real-world data.

Community Partnerships

Assess whether the CRO actively collaborates with local organisations and patient advocacy groups in the regions they represent. Understand the scope of their community access and their use of culturally relevant marketing and recruitment strategies that resonate with local participants. Consider partnerships with healthcare providers, such as doctors and pharmacists, who are trusted by patients for education and enrolment.

Regulatory Expertise

Ensure that the CRO possesses a strong understanding of regulatory processes and adheres to relevant guidelines. Address any gaps in their comprehension of these guidelines.

Diversity Focus and Training

Look for a CRO that not only acknowledges FDA guidance on diversity, but is also familiar with patient-centric and expanded eligibility guidance. Assess their active efforts to develop tools and strategies for inclusive trials, including potential consultation with social psychologists who can facilitate connections with specific populations.

Proactive Corporate Social Responsibility

Evaluate the CRO’s commitment to diversity, equity, and inclusion as part of their CSR initiatives. Ensure that these goals extend both internally and externally, demonstrating a dedication to diversity in their workforce and in the clinical trial populations they engage with.

Selecting a CRO with a comprehensive approach to diversity and inclusion can significantly enhance the success of clinical trials and contribute to more equitable healthcare outcomes.

Conclusion

Diversity and inclusion in clinical trials are vital for achieving equality within the healthcare industry. Challenges like bias, language barriers, and distrust must be addressed before healthcare settings, like clinical trials, can expect to see an increase in the diversity and inclusion. Working alongside a diverse operating CRO can help with increasing diversity and inclusion, but all stakeholders involved must play a role.

To create a more inclusive future, we must adopt a patient-centric approach, expand recruitment, diversify teams, and enhance data infrastructure. Diversity isn’t just a requirement; it’s the foundation of fair healthcare.

Learn more about our CRO Services today, to see how we can work together and be part of the change for equal healthcare access. Together, we can make a difference. To discuss how Simbec-Orion can help with improving the diversity and inclusion in your clinical trials, get in touch with our team.

Back to Blog Archive