CROs and sponsors need to set enrolment goals early and make trials more accessible says the chair of ACRO’s diversity and inclusion committee, which issued a principles statement on the subject this week.
Calls to make clinical trials to make trials more diverse by increasing involving more participants from a broader range of ethnic groups have increased in recent years.
In April, for example the US Food and Drug Administration (FDA) set out draft guidance designed to encourage the drug industry to enroll more participants from underrepresented racial and ethnic populations in the US clinical trials.
FDA Commissioner Robert Califf said the aim was to ensure trials are representative, explaining “The US population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.”
And the guidelines are already having a positive impact says Rachael Fones, ACRO D&I Committee Chair and Director, Government & Public Affairs and Strategic Advisor, Diversity in Clinical Trials at IQVIA, who told Clinical Insider about the industry group’s new principles statement this week.
Why is it so hard to achieve patient diversity in clinical trials?
“Historical issues around the mistreatment of minority populations and subsequent mistrust in clinical research are well documented. There is no shortage of literature and opinions about the barriers, and generally the focus is on the potential participants themselves with a particular emphasis on trust, socioeconomic factors, and access issues.
“Certainly these bear thoughtful consideration, but we also need to challenge the narrative.
“We need to be more intentional about enrollment diversity -- with our sites and with our outreach efforts, so the question should really be: If we collectively do a better job of asking diverse patient to participate, having more accessible sites in the community, and meeting diverse patients in a culturally tailored way, is it actually difficult to achieve?
“This is why we created the ACRO statement. The ACRO principles focus on actions CRO and technology member companies can take to help drive diversity in clinical trials. We won’t solve all the systemic problems, yet with today’s technology, data and collective will, we can move the needle toward making representative clinical trial enrollment the norm.”
Various regulators have moved to encourage sponsors and CROs to increase participant diversity in trials – The FDA’s recent diversity guidance being the obvious example - how effective do you think these measures will be?
“The latest FDA Guidance focused on diversity plans is having an impact already, and at the point where it can really make a difference – in upfront planning of new trials. We are seeing sponsors start discussions about goal setting and tactical efforts to improve diversity earlier in planning, when diversity goals can be set alongside other key parameters.
“At IQVIA, we have been advocating that the opportunity for real progress is at the operational planning level and are pleased to see this shift. Proactive and intentional goal setting, embedding diversity into the planning and execution of the trial, carrying that focus through site selection, start up, recruitment, and retention along with closely monitoring progress can ensure diversity goals are achieved in concert with all trial goals. In fact, we’ve built our Trial Lifecycle Approach to Diversity with this in mind.”
What measures will CROs need to take to boost diversity in trials? I’ve seen examples where contractors have partnered with community clinics or teamed with AI developers to identify participants faster – what other approaches are being tried?
“Some approaches we’ve seen across ACRO members include collaborating with sites to identify their needs and help them partner with the community, decentralizing elements of the trials to appeal to a broader set of potential participants, utilizing technology to reduce burden of community sites and participants and, of course, data and analytics to identify the right mix of sites with the right patients. Another way utilizing data analytics and AI that IQVIA has found particularly successful is through dynamic, multi-channel direct-to-patient campaigns, which have had a measurable impact in supporting overall recruitment efforts and diversity goals.”
How are diversity enhancement efforts likely to impact clinical trial costs? Recruitment is obviously a major part of the cost of any trial, so surely any effort to attract participants from communities who traditionally do not take part in research is likely to increase costs and time lines – is that a fair assessment?
“Too often, clinical trial diversity efforts have fallen short because diversity isn't focused on until after site selection and start-up – or when all the ‘machinery’ that runs massive phase 3 trials is already in action. Adding programs and new materials during recruitment is too late, ineffective, costly, and reinforces beliefs that diversity goals mean added time and cost.
“When sponsors, CROs and sites make diversity goals part of the plan from the start – rather than a goal added after sites have been activated – they can make adjustments that improve access and appeal of trials for diverse populations.
“During the pandemic, we saw many sponsors meet or exceed diversity goals while staying within tight budgets or timelines.
“For example, in one study conducted by IQVIA, a large pharma company recruited more than 40,000 patients to a vaccine trial in just eight weeks while exceeding its diversity goals. This success resulted from upfront planning that included diversity-informed site selection, clear goal setting with individual sites, targeted outreach efforts and careful monitoring of the recruiting funnel to ensure diverse populations had the chance to participate.
“The bottom line: when we are all working in the same direction, with intention – we’ve seen success. ACRO and its member companies are committed to working with our research partners to build on that success and help bring about sustainable change.”