How to ensure gender diversity in clinical trials

clinical trials diversity

Labiotech sat down with Alicia Staley, VP, patient engagement at Medidata, a Dassault Systèmes company, to discuss underrepresentation of women in clinical trials and the importance of making trials more diverse.

What does the current landscape look like with regards to gender diversity in clinical trials?

While we’ve come a long way since the 1990s and early 2000s, when women were widely underrepresented in trials, there continues to be a diversity gap that needs to be addressed. A recent study published in Contemporary Clinical Trials shows that sex-based gaps still persist in trial populations and this underrepresentation contributes to gender health inequity. For example, women have been historically underrepresented in cardiovascular disease clinical trials, despite it being the leading cause of death among women worldwide.

What difficulties are there in trying to achieve gender diversity? What do you think are the main misconceptions around diversity in patient populations of clinical trials?

For clinical trials to be more representative of the populations they serve, the diversity gap needs to be addressed at all levels – and this includes at management level. Diversity with respect to clinical trial leadership is associated with greater levels of diversity in trial patients. Having diverse leaders across the clinical trial ecosystem is shown to increase innovation and to have a positive impact on trial design, leading to greater levels of diversity in trials. Clinical trial teams also need greater visibility on the recruitment process, to ensure they are hitting the right targets in terms of patient populations.

In terms of misconceptions, a big one, conversely, is that the focus is on the lack of women participants or individuals from underrepresented minority groups. It is not as simple as it seems.

Breast cancer, for example, has always been considered a “women’s disease”, yet one in 833 men will develop breast cancer in their lifetime. Despite this, men are vastly underrepresented or not represented at all in these trials. We need to think about how we can change our approach to enrollment to ensure we take factors like this into account.

How can a lack of gender diversity impact clinical trials outcomes? What implications does this have at the subsequent stages?

Lack of diversity can have a significant impact on clinical trial outcomes. Everyone is different, and individuals from different genders and backgrounds do not metabolize drugs and treatments in the same way. If we don’t address the diversity gap properly and take a closer look at disease prevalence in different patient populations, we risk developing drugs that may be ineffective or negatively impact people’s health.

Some diabetes trials have historically failed to enroll non-white ethnic minorities despite this group being more susceptible to and having a higher incidence of type 2 diabetes compared to the wider population and from the early age of 25. In addition, failing to consider diversity and assess drugs on the correct patient population can be costly as it could result in misleading or skewed data. Ensuring diversity from the outset of a trial will avoid situations where drugs end up going back to the lab, wasting valuable time and money.

How can the industry close the diversity gap and promote/encourage more women in clinical trials? What is Medidata doing in this area?

In addition to ensuring diversity across the workforce, including in leadership positions, as mentioned previously, and promoting equality and inclusion internally, technology will also play an important role in supporting the industry in bridging the diversity gap. Using technology to monitor patient enrollment enables trial investigators to make a judgment call on recruitment numbers and patient profiles in real time.

Medidata has done a lot of work in this area – we’ve developed tools that can help with patient recruitment and retention. The company’s ‘intelligent trials’, an analytics solution that brings together cross-industry real-time performance metrics, predictive models, and forecasting capabilities, have a diversity module which provides site-level participant demographic data including race, sex, age, and ethnicity.

The module enables clinical trial site sponsors and contract research organizations (CROs) to benchmark trial diversity so that they can identify sites that are more successful at enrolling diverse patients. These insights make diversity an important factor at the early stages of trial planning, when companies are still evaluating where to conduct their trials, and they can help speed up the entire process.

The theme for this year’s International Women’s Day (IWD) is DigitALL: Innovation and technology for gender equality. How do you think innovation and technology can help equality in clinical trials? To what extent can regulators help advance gender diversity in trials?

As I touched on previously, technology can play a significant role in supporting the industry in making trials more diverse. Technology allows trials to be ‘decentralized’, which means patients can spend more time being monitored remotely at home, rather than travelling long distances to trial sites. This, in turn, supports the participation of people who might not otherwise have been able to take part in a trial, such as those with childcare duties or who cannot afford to travel. This leads to better data, which is more reflective of the general population and ultimately helps drug developers to better understand the different effects that new compounds may have on different groups of people.

Regulators are also supporting the industry in addressing the diversity gap. In April 2022, the US Food and Drug Administration (FDA) published draft guidance on how the industry can improve clinical trials diversity. In the guidance, the FDA recommended that sponsors submit a race and ethnicity diversity plan (with strategies to hit predefined metrics) in the early stages of clinical trial development to ensure trials are more diverse and representative – which is encouraging.

To what extent do you think awareness days like IWD are important in showcasing the underrepresentation of women in clinical trials?

Awareness days are crucial in shedding light on these important issues. It’s easy to get lost in our day-to-day lives and awareness days play an important role in encouraging conversations which help drive things forward. Since 1988, December 1 marks World AIDS Day, an annual day to raise awareness of HIV. The awareness day has been highly successful, the red ribbon is instantly recognised by many, a reminder for all of the disease. The red ribbon launched thousands of awareness days and showed the power in driving change.

How do you view the future of trials with regards to patient diversity?

We’ve made significant strides in making trials more diverse and I believe the industry is going in the right direction. I applaud efforts made at all levels, but our work is not yet done. We need to continue working together and focus our efforts in addressing a key issue at the root: building more diverse workforces. Without addressing inequities throughout the clinical trial ecosystem, we won’t be able to truly achieve Diversity, equity, and inclusion for all participating in clinical trial research.

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