By Lucy Radley, Senior Vice President, Head of European Regulatory Development at ProPharma Group.
Clinical trials are, undoubtedly, an essential part of the drug development process, providing us with valuable information about the safety and efficacy of new treatments and therapies. However, despite their deep importance to the wellbeing of patients, persistent inequalities continue to plague the industry, particularly in regard to the underrepresentation of diverse groups and genders in these studies. This lack of diversity has, and continues to have, serious consequences, including delayed approval of drugs for minority populations and ineffective treatments for certain demographics. Everyone experiences diseases differently and has varying reactions to the same drugs, and so it is vital that clinical trials include those with a variety of racial and ethnic backgrounds, as well as gender, sexuality and ages. With World Health Day having taking place recently (7 April), there has never been a better time to address these inequalities head on and highlight the role of the pharmaceutical industry in improving this.
Under-representation in clinical trials and its consequences
Clinical trials are intended to represent the populations for whom the treatments are intended. However, studies have repeatedly shown that certain groups are consistently under-represented in clinical trials, including women, racial and ethnic minorities, and elderly populations. This under-representation has been particularly highlighted with respect to the treatment development for cancer, dementia and cardiovascular diseases, despite these disproportionately affecting people of colour in the UK1.
Similarly, this disparity in medical research was emphasised during the pandemic, where non-white ethnicities were disproportionately affected by Covid-19 but under-represented in clinical trials for vaccine development. In fact, these demographics which make up 13.8% of the UK population represented only 5.7% of participants2 Covid-19 vaccination trials.
This lack of representation has significant consequences. First, it can lead to delayed approval of drugs for minority populations. Clinical trials are used to determine the safety and efficacy of new treatments, and if these studies don’t include diverse groups, it may be difficult to determine whether a drug is safe and effective for these populations. This can lead to delays in approval, as regulatory agencies may require additional studies to be conducted in these populations before a drug can be approved.
Additionally, a lack of diversity in clinical trials can result in ineffective treatments for certain patient groups. For example, some medications may work differently in different populations due to genetic or environmental differences. If a drug is not tested in diverse populations, it may not work as well or may even be harmful for certain patient groups. Diversity in clinical trials is important for promoting health equity and ensuring that everyone has the opportunity to achieve their highest level of health, regardless of their race, ethnicity, gender, or socioeconomic status.
Existing barriers to diversity and equity in clinical trials
There are several existing barriers to diversity and equity in clinical trials that contribute to the lack of diversity in the clinical research process.
Patient-related barriers include lack of trust in the healthcare system among some communities, language barriers, cultural differences, and accessibility issues. For example, some communities may not be made aware of clinical trials and may not trust the healthcare system due to past experiences of discrimination and mistreatment. Women may feel that their concerns about their health are not taken seriously, as found by a recent report for Women’s Health Strategy for England. Similarly, an ongoing history of medical racism3, neglect and mistreatment has left long-lasting negative impressions of the healthcare industry.
Language barriers can make it difficult for individuals who are not fluent in the national language(s) of the country in which they reside to understand the trial requirements and provide informed consent. Cultural differences can also impact participation, as some groups may have different beliefs and attitudes towards healthcare and medical research. Finally, accessibility issues such as lack of transportation or inability to take time off work may prevent certain populations from participating. It is vital that all of these factors are taken into account by pharmaceutical professionals and not dismissed, to ensure that steps can be taken to make healthcare equitable and rebuild the trust that has been broken.
The steps needed to accelerate equity
To address the lack of diversity in clinical trials and ensure that we accelerate equity, the pharmaceutical industry can take on several actions. Diversity firstly needs to be increased in clinical trial design teams to ensure that different perspectives and experiences are represented in decision-making processes. It is vital that we ensure that we are helping all populations through innovation, experience, knowledge and efficiency – things that are greatly enhanced by diversity of thought and people. For diversity within clinical trials themselves, we need to actively engage with and recruit under-represented groups through targeted outreach and community partnerships. This also requires thorough collaboration with regulators, patient advocacy groups, and other stakeholders to identify and address barriers to participation in clinical trials for underserved groups.
It is important to note that while the pharmaceutical sector has a significant role to play in addressing under-representation in clinical trials, addressing healthcare inequalities and ensuring equitable access to healthcare is a complex and multifaceted challenge that requires collaboration from all stakeholders, including healthcare providers, policymakers, and patients themselves. Without diversity across all levels, we cannot ensure that health equity is at the centre of our industry. By ensuring that clinical trials include diverse populations, we can work towards eliminating health disparities and ensuring that everyone has access to the best possible care.