Worrying signs for trial diversity require broad industry action

A recent report found that diversity in clinical trials has dropped. Ben Hargreaves examines why diversity in trials is needed and what recent action has been taken to improve the current situation.

The momentum behind increasing diversity in clinical trials has been gathering pace in recent years. This movement is happening across the industry, as pharmaceutical companies, regulators, and the many other stakeholders involved in bringing treatments to patients acknowledge that more needs to be done.

However, the work that is still to be done was made obvious by a recent IQVIA report, which found that Black/African American and Hispanic patient representation had actually declined since 2012. This emerged as something of a surprise, given the increased focus on diversity. Following release of the report, Murray Aitken, executive director of the IQVIA Institute for Human Data Science, concluded that “more work needs to be done to improve diversity.” There have been notable steps in this direction in recent months, but the question remains whether this is enough to improve the situation by the time of IQVIA’s next report.

Understanding the barriers

For much of the history of clinical trials, representation in trials was largely dominated by white male participants. Now, it is better understood that different groups can have distinct disease presentation or health circumstances that affect how they will respond to treatments. It is important to promote greater diversity in trials to ensure that all groups, particularly those that have often been underrepresented, are ensured access to trials. The reasons are various, but the bottom line is to ensure that everyone is able to access the same treatment options, and also to progress overall understanding of diseases and conditions. By limiting the diversity of patient populations into trials, gaps have been created in knowledge of treatment efficacy across populations, and of preventative factors in disease development. There is also the economic cost to consider, with estimations that reducing disparity of healthcare outcomes related to differing population groups could save the US economy billions.

As the industry recognises the need to address the issue and pushes towards greater diversity, a new set of challenges emerges: how to ensure that people who are eligible for clinical trials have access to them. According to research, there are five main barriers that currently hinder minority groups from being represented in clinical trials: mistrust, lack of awareness and access, cultural and language barriers, investigator and provider bias, and financial burden.

Institutional diversity

To address all five of these issues will take an industry-wide approach, but one that can be led by the regulators. Last year, the US FDA announced that it was taking steps to increase racial and ethnic diversity in clinical trials. The draft guidance, which was released at the beginning of this year, recommends that sponsors of medical products develop and submit a plan early in clinical development that addresses some of the barriers mentioned that prevent greater diversity.

The guidance recommends that drug sponsors should include enrolment goals for underrepresented racial and ethnic participants, which should form part of the protocol objective of the study. Clinical studies should also assess the data generated to determine whether the medical product could have a differential safety or effectiveness associated with race or ethnicity. In cases where there is already data suggesting that the medical product could perform differently, the guidance states that the plan should specify the study features that will support analyses of this factor. The guidance also proposes additional recommendations, with the aim of helping the industry to develop specific approaches to improve racial and ethnic diversity.

Industry action

For its part, the industry is recognising this need to improve diversity. Recent years have seen an increase in action and focus on improving diversity in trials. Abbott recently announced that it would take several steps to improve diversity in clinical trials and to improve care among underrepresented populations. The action includes working with the Institute for Health Equity at Norton Healthcare to build research programme models to serve underrepresented communities. Beyond this, the company revealed that it would provide an education programme to support coordinators from diverse backgrounds, and that Abbott would establish a Diversity in Research Office within the company.

When asked for more details on the latter initiative, an Abbott spokesperson stated, “Our new Diversity in Research Office is responsible for ensuring that research efforts across the company include diversity plans, key performance goals, and foster collaboration to increase diversity across the organisation, the industry, and regulatory bodies.”

Regarding its overall efforts, the spokesperson added, “Greater diversity in clinical trials is key in driving new medical advancements that improve the lives of everyone regardless of their ethnic or cultural background or socioeconomic factors. Abbott’s Diversity in Clinical Trials initiative is designed to create a more inclusive clinical trial ecosystem and, in turn, create a more equitable healthcare system with life-changing medical devices.”

Broad stakeholder backing

For implementation of change to meaningfully support more diverse clinical trials, effective action has to occur from a broad spectrum of stakeholders. The American Lung Association (ALA), a non-profit organisation focused on lung health, is taking action within its own area by highlighting and working to aid the poor health outcomes faced by Black Americans in lung cancer.

The organisation recently took action to launch the Awareness, Trust, and Action programme, which aims to increase awareness among Black Americans about clinical trials, and to encourage conversations around the availability of treatment options. According to the ALA, Black Americans with lung cancer are less likely to be diagnosed at an early stage, less likely to receive surgical treatment, and less likely to receive any treatment at all when compared against white Americans.

Tai Zahir, national director of lung cancer education for the American Lung Association, explained why this is: “One of the many reasons that Black Americans have lower survival rates is from mistrust in clinical trials. Our nation’s history has not been without blemish in the endeavours of scientific research. One such example of this was the Tuskegee trials of the 1930s-70s. This historic mistrust has led to an underrepresentation of Black Americans in modern clinical trials.”

ALA will work on its efforts with the support of the pharma industry, which Zahir noted would provide some of the finances required to improve awareness for the project. With awareness built of the availability of treatment options through research, Zahir stated that not only could Black Americans receive greater access to medical care, but that broadly improving diversity can help researchers determine whether drugs are safe and effective for those with a similar background.

Through the work across the industry, there is more finance and focus being placed on ensuring that diversity across clinical trials should improve in the years to come. The test will arrive when research organisations, such as IQVIA, begin a review of diversity figures in the years to come. The report by IQVIA referenced at the beginning of this article is based on historical data over the last decade. The hope is that representation figures begin to improve in future reports, as the greater emphasis on diversity in recent times begins to filter through into clinical trials.