Why are clinical trials struggling with diversity? –

In the diverse world we live in, the products we make, the services we create and the places where we work must be equally representative. In recent years, diversity, equity and inclusion (DEI) has become a major goal for industries.

Within the pharmaceutical and healthcare industry, where greater representation has been proven to lead to better health outcomes for all patients and pharmaceutical companies developing drugs, changes are also underway.

Equitable and timely access to effective medicines is one of the core principles of the health sector and is a critical component of the environmental, social and governance (ESG) objectives of the sector. But historically, certain groups are generally overlooked due to the current systems in place. Racial disparities are still commonplace in many clinical trials with white ethnic groups often overrepresented among trial participants.

Factors such as ethnicity, gender, sexual orientation, and age may contribute to interindividual differences in treatment responses and risk of adverse events. Inadequate clinical trial representations of all populations may therefore make underrepresented groups vulnerable due to the lack of subgroup-specific data.

While many pharmaceutical companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. The good news is that technology is being harnessed to promote an IED-conscious agenda in the clinical trials space, making diversity more accessible than it has ever been.

To understand why improving diversity, mitigating bias, and enhancing inclusion in clinical trials is such an important task, it is important to understand the challenges currently at play.

Unboxing the status quo

Traditional randomized controlled trials (RCTs) continue to form the backbone of clinical efficacy and safety data submitted to health authorities for regulatory review. A risk-benefit approach underpins the decision-making process for evaluating human drugs, drug/device combinations, and advanced therapy drugs for human drug licensing.

It is well established that safety and efficacy data are strongly influenced by internal (intrinsic: ethnicity, gender, age, genetic heritage) and external (extrinsic: climate, education, access to health care) factors. The challenge for regulators and pharmaceutical companies is that the safety and efficacy data from an RCT may not always translate into a drug’s actual “effectiveness” (the drug’s effectiveness in patients once marketed), which is governed by these complex intrinsic and extrinsic factors. factors.

To mitigate against potentially inferior drug efficacy or a different drug safety profile in a broader population compared to outcomes highlighted in RCTs, it is important for companies to include “patient-focused” outcomes (symptom relief ) alongside traditional parameters (blood pressure, glucose concentrations). The diversity of clinical trial patients in the context of disease prevalence is key to capturing “patient-centred” outcomes in populations. For example, with skin conditions, textbooks, studies, and test photos often show the symptoms of lighter-skinned people, which are likely to differ in darker-skinned people.

The pandemic has exposed the imbalances

The race to produce a vaccine that could protect the world against COVID-19 has brought the topic of clinical trial diversity, or lack thereof, to the fore.

Vaccines approved for public use require full RCTs to establish their safety and effectiveness. The demographics of participants in vaccine trials should reflect the vulnerable groups for whom infection with the disease poses the greatest risk of harm and mortality. However, this did not happen to the extent that it might have happened during COVID-19 vaccine trials.

Research has shown a disproportionately higher rate of COVID-19 infection and death among older people and ethnic minority groups who are more likely to be negatively affected by social and economic deprivation linked to pre-existing health conditions . In the UK, during the first wave of the COVID-19 pandemic, minority ethnic groups (with the exception of women in the “Chinese” or “other white” categories) had higher post-exposure death rates than the “White British” population.

These problems are not limited to the UK; in the United States, certain minority groups, including Blacks, Latinos, Pacific Islanders and Indigenous peoples, have been shown to have twice the death rate from COVID than Caucasians.

Despite policies, guidelines and regulations to promote the diversification of clinical trial groups by the European Medicines Agency (EMA) and the FDA, the inclusion of key demographic populations in clinical research continues to be less than proportional to their representation in society.

Why are certain ethnic groups under-represented?

Correcting the imbalance in trial participation is not a simple task. Throughout the pandemic, the problem of vaccine hesitancy has been compounded by ethnic disparities. This is underpinned by a historic distrust of health care organizations, governments, and clinical research, which still prevails in some communities.

Factors influencing trust vary across ethnic groups. Reported experiences of discrimination, perceived structural inequalities impacting health care access and quality, and concerns about trial underrepresentation are likely to influence issues of trust, which companies bear responsibility for. to recognize and deal with appropriate measures to achieve this. cash. Without diverse participation in clinical research, data on safety and effectiveness are lacking. Certain groups of individuals may then not believe that the drugs were produced with them in mind and may be highly skeptical of the resulting evidence base and prescription label of the drugs.

In the second half of this article, we’ll look at how technology is being used to diversify clinical trials and look at some of the lessons learned during the COVID-19 pandemic.

About the authors

Tanya Chambers is a former Senior Evaluator for the Medicine and Healthcare Regulatory Agency (MHRA) with over 15 years of experience primarily in the evaluation of preclinical datasets (small molecules and biologics) accompanying clinical trial applications, EU and UK marketing authorization applications (MRP/DCP/Centralized submissions) and variations across all therapeutic areas. Most recently, Tanya led the ongoing preclinical review of COVID antiviral applications, which resulted in national rollout, and served as product manager for review of a wide range of development programs through innovative licensing pathways at United Kingdom: iLAP and EAM. Additionally, Tanya has a working knowledge of collaborative review of promising oncology treatments alongside Australia (TGA), Canada (Health Canada), UK (MHRA), Singapore (HSA), Switzerland (Swissmedic) and Brazil (ANVISA): ‘Project ORBIS’.

Liam JohnstonLiam Johnstone has six years’ experience in toxicology with regulatory bodies in the UK, developing expertise in the areas of medicine, consumer products and agrochemical safety while working respectively at the MHRA, OPSS and HSE. As a non-clinical evaluator at the MHRA, he assessed non-clinical datasets for new and generic drugs. He has provided scientific advice to companies both nationally and as part of the Scientific Advice Working Group (SAWP) on the relevance of non-clinical datasets and study designs, as well as on the production of guidance for the European Medicines Agency (EMA)

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