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Diversity in Clinical Trials: Significance & Challenges

By Jan Filakovsky, CEO of Biomapas

Diversity in clinical trials is crucial in ensuring that research findings are broadly applicable, and in avoiding treatments that are ineffective or even harmful to underrepresented groups due to variations in genetics and environmental factors. In this article, we will explore the critical importance of diversity, examining both the ethical and practical approaches to including a wide range of participants in clinical research. We will discuss the challenges faced in reaching diverse populations, such as language barriers or socioeconomic obstacles, logistics, and ensuring the highest compliance and data integrity. Additionally, we will review recent diversity guidance from the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA).

In this article:

 

  1. Significance of Diversity in Clinical Trials
  2. Challenges in Reaching Diverse Populations
  3. FDA Diversity Guidance & EMA Regulations
  4. Our Commitment to Diversity
Janos Filakovsky

Significance of Diversity in Clinical Trials    

Besides the obvious ethical responsibility to ensure that medical research benefits everyone, not just a select few, there are several reasons why diversity plays a crucial role in the success of clinical studies. When trials lack diversity, the results may not be applicable to the broader population, potentially leading to ineffective or even harmful treatments for underrepresented groups. For instance, genetic and environmental differences among various populations can influence how diseases manifest, and how treatments are metabolised. If minority groups are underrepresented in trial settings, these critical variations could go unnoticed, resulting in misleading data that fails to account for the full range of human diversity.

Diverse participation in trials helps to uncover health disparities and address them more efficiently. Some diseases disproportionately affect certain populations, and without their inclusion in trials, researchers might miss important insights into disease mechanisms and treatment responses. This can perpetuate health inequities and limit the effectiveness of new medical interventions. By ensuring that clinical trials include a wide range of participants, researchers can develop treatments that are safe and effective for a broader and, for a targeted population, ultimately leading to more equitable healthcare outcomes. 

Challenges in Reaching Diverse Populations 

Researching diverse patient populations in clinical trials is essential for ensuring that treatments are applicable across different demographics. Even so, several challenges and barriers persist: 

Logistical obstacles

Many individuals from diverse backgrounds find participation in clinical trials hindered by a lack of access to trial sites, which are often located far from underrepresented communities. The time commitment required for participation, including multiple visits and complex procedures, can be burdensome for individuals who may have work, family responsibilities, or limited transportation options. 

Additionally, there is a growing need to address the increasing technology demands at the site level, including the use of various systems like electronic data capture, IT support and training, system compliance, data entry, and data protection. While emerging regions are quickly adopting new technologies and improving technology literacy, challenges remain. Hospitals still face obstacles in transitioning from paper-based patient records to electronic formats in clinical trials. Patients using electronic data capture systems may require extra training and careful planning to ensure success.  

Mistrust in the health care system

Another critical challenge, particularly among minority groups. Historical exploitation and unethical practices in medical research have fostered deep-rooted scepticism, making recruitment efforts difficult. This mistrust is often compounded by a lack of representation among the researchers themselves, which can further alienate potential participants. 

Socioeconomic factors

Circumstances, such as financial instability and limited access to health care can prevent diverse populations from participating in studies. Individuals with lower incomes or those without health insurance may prioritise immediate financial needs over long-term trial involvement, especially if there are out-of-pocket costs involved. 

Language & communication issues

Participants from diverse backgrounds may have limited proficiency in the primary language of the trial, leading to misunderstandings about processes, risks, benefits, and even consent. o ensure success.  

Addressing these barriers requires targeted strategies, such as providing multilingual resources, building trust through community engagement, improving the accessibility of trial sites, and offering financial support or incentives. Biomapas’ extensive presence in emerging markets, and more than 20 years’ of experience in developing and supporting ecosystems for clinical research development in new geographies, allow for unique access to these underserved populations. Moreover, with employees speaking multiple languages across Europe, we are well-equipped to overcome these challenges and ensure that diversity is effectively included in all aspects of the trial design.

FDA Diversity Guidance & EMA Regulations

The FDA’s draft guidance on Diversity Action Plans (DAPs) for clinical trials, released in June 2024, represents a significant step toward ensuring that clinical trials better reflect the diverse populations expected to use the tested medical products. For CROs and sponsors, aligning with these guidelines not only means meeting with regulatory requirements but also enhancing the scientific validity and social relevance of clinical research. 

Key components of the FDA’s guidance include the mandatory development of DAPs, which outline strategies for enrolling diverse participants and set specific goals and metrics to measure progress. Under the Food and Drug Omnibus Reform Act of 2022 (FDORA), sponsors must submit these plans with their investigational new drug applications and marketing authorisation submissions. The guidance also suggests strategies such as community engagement, partnerships with local health organisations, and leveraging digital tools to reach broader audiences. In addition to stressing the importance of cultural competence among trial staff to build trust with potential participants. 

While the EMA does not have one overarching document equivalent to the FDA’s diversity guidance, various guidelines and initiatives ensure that clinical studies apply to the broader population. These guidelines are part of the Good Clinical Practice (GCP) framework in the EU, with the most relevant being Clinical Trials Regulation (EU) No 536/2014, which came into effect in 2022.  

The regulation mandates that clinical trials conducted in the EU are designed to be representative of the population that will eventually use the medicinal products, thereby enhancing the generalisability and applicability of the study results. This means that unless justified otherwise, clinical trials under No 536/2014 must include a participant pool that mirrors the broader population in terms of gender, age and potentially other characteristics like race and ethnicity.  

Biomapas, with its extensive presence in the EU, along with developed and emerging markets worldwide, is uniquely positioned to support sponsors in navigating these regulations and ensuring compliance. With up-to-date technology, medical advisers, and a deep understanding of industry trends, we are dedicated to fostering diversity in clinical trials, ultimately leading to better healthcare outcomes for all. 

Our Commitment To Diversity

Recognising the growing need for clinical studies to encompass a wider representation of diverse communities, Biomapas incorporates diversity by leveraging our existing trial-naive sites across CEE, CIS, Georgia, and Eurasian regions, to provide representative, applicable, high-quality, integrated trial data. We ensure that clinical trial conduct is in line with the highest ethical and research standards compliance.  

Our range of services, including Biomapas Academy professional training, and consultancy to all members of the clinical research ecosystem: hospitals, health– and regulatory authorities, and dedicated Quality Assurance specialists, further establish our commitment to enhancing clinical research. We boast a dedicated network of clinical trial coordinators supporting research sites.  

We take our corporate commitment to Environmental, Social, and Governance (ESG) standards seriously, and we work closely with our vendors who meet the same standards. We also partner with our clients to support and help them achieve their diversity goals in clinical trials. As a responsible industry player, we align our efforts with clients to promote sustainability and ESG principles throughout our collaborations.  

We offer a wealth of expertise in innovation and ethical practices for all Biopharma companies seeking expansion into these regions. Together, we can shape the future of medicine.

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