Introduction
Inclusivity: A Problem with Clinical Trials
Under-Served Groups
Examples of Barriers
Benefits of Improved Inclusivity for Clinical Trials
Summing Up
References
Clinical trials are a cornerstone of medical research and the process of introducing safe, effective drugs and treatments onto the market. Historically, clinical trials have been lacking concerning inclusivity. This article will examine the importance of inclusivity in clinical trials and the barriers to inclusion surrounding under-served demographic groups.
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Inclusivity: A Problem with Clinical Trials
Because pharma products are designed to serve different population subgroups with diverse ages, sex, ethnicity, and genetic profiles, which may differ in their clinical responses to treatments, it is essential to design a clinical trial that serves all demographics. Diversity and inclusion should be a research priority, but historically this has been difficult to achieve for numerous reasons. If a trial does not include this consideration, it can be said to be flawed by design.
Racial and ethnic minorities continue to be under-represented in trials. The barriers are well understood, but sustainable options to overcome them have thus far proven difficult to realize. For example, African Americans make up 20% of multiple myeloma sufferers in the US, but they only account for 6% of individuals included in trials. Similarly, 11.2% of all type 2 diabetes suffers in the UK are South Asian, but they represent only 5.5% of individuals in trials.
The need for improved inclusivity in trials has been highlighted during the COVID-19 pandemic, as ethnic minorities are disproportionately affected by the disease. In the UK, a June 2020 report by Public Health England highlighted that individuals from the black ethnic group were more likely to be diagnosed with COVID-19, and deaths were higher in Black and Asian ethnic groups. Black males were 4.2 times as likely to die from the disease than White males. However, there is a lack of data on the effectiveness of treatments for ethnic minorities.
Clinical trials must include data on ethnic minorities and other under-served populations. However, there is no legal obligation to report and record ethnicity in clinical trials in the UK. Amongst 1,518 COVID-19 clinical trials highlighted in a June 2020 systematic review, only six had collected ethnic diversity data. While projects such as the UK’s NIHR-INCLUDE aim to correct this, there is still a significant amount of progress needed to ensure better trial inclusivity.
Under-Served Groups
The term “under-served group” reflects the perspective that there are barriers to some groups for inclusion in trials, meaning that they are not served as effectively by the clinical community. The lack of inclusion is not their own fault.
There are many types of under-served populations. This includes mental health patients, smokers, people with addictions, educationally disadvantaged individuals, physically disabled individuals, obese individuals, geographically isolated populations, ethnic minority groups, individuals excluded by digital barriers, socially marginalized populations, language barriers, elderly people, religious minorities, and patients with rare diseases.
While there is no single definition, characteristics of under-served groups include lower inclusion than would be expected from population estimates. This high healthcare burden is unmatched by the volume of research designed for them, differences in how they engage with and respond to healthcare interventions, and how research neglects to address these issues.
This definition is context-specific. It depends on the population, the interventions and conditions being studied in the clinical trial, and the questions asked by researchers. Designing trials that include under-served demographics is key to improving them and accurately identifying clinical outcomes.
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Examples of Barriers
There are many barriers to inclusivity in clinical trials. These include lack of available trials and poor promotion, difficulties with consent and poor consent procedures, lack of initiatives for participation, lack of research interest, cultural barriers, risk perception, health fears such as needles and hospitals, lack of trust, and negative financial impacts.
The UK’s NIHR-IMPACT project has designed questions to help improve the inclusivity of clinical trials. These questions cover inclusive research design, assessing the inclusivity of trials, and guidelines for improving the inclusion of under-served groups.
Benefits of Improved Inclusivity for Clinical Trials
Improving the inclusivity of clinical trials does not just benefit under-served groups; it also benefits the trial itself. Firstly, if it does not include a broad range of participants, there may be issues with generalizing the results across a broad population. Secondly, the balance of benefit and risk can be better established by including a broad range of participants.
Additionally, logistical, sociocultural, biological, and psychological differences increase the complexity of intervention delivery, impacting its success. Evaluating whether an invention will be effective across diverse groups ensures its practicability. Moreover, a clinical opinion may take the place of scientific evidence if there is a lack of data for particular groups which can accurately inform clinical decisions. Finally, there is a moral justification for inclusion based on the principle of “no decision about me, without me.”
Summing Up
Historically, inclusivity in clinical trials has been an issue, as evidenced by several studies and the COVID-19 pandemic. The barriers to inclusion are well-understood, but sustainable solutions have thus far been challenging to realize. Inclusivity as a design element will only serve to improve future clinical trials by providing better data across populations and providing better clinical outcomes of interventions and treatments.
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Further Reading
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