With regulators and industry focused on diversity action plans, diversity, equity and inclusion (DE&I) is poised to be a huge priority this year. A recent survey reveals what is and isn’t working for sites on diversity tactics and how sponsors can best lend a hand.

The survey, published in Clinical Pharmacology and Therapeutics and led by Demi MacLennan, a project manager with Labcorp Drug Development, was sent to 198 clinical research professionals employed at U.S. sites with the aim of providing a boots-on-the-ground perspective on how they’re working to meet diversity goals.

The 72 survey questions inquired about respondents’ current knowledge and perspectives on methods for recruiting and retaining participants and their impact on diversity in trials.

Not surprisingly, most respondents (98.6 percent) supported the idea of enrolling a diverse cohort, and 68 percent said they try hard to do so. About 57 percent said that study leadership/management does invest time and energy in enrolling diverse study participant populations.

But about 32 percent also said their own workforces lacked diversity or had minimal diversity.

Regional differences were apparent; low diversity was more common in Midwest respondents (42.5 percent) compared to 18.3 percent of staff from other regions. Midwestern respondents were also less likely to have at least one bilingual staff member (35.4 vs. 71.2 percent).

Although sites have tried educating their staff about diversity issues, some efforts weren’t fruitful. For example, about 70 percent of the sites required training in implicit bias. Yet just 28 percent of respondents felt that this training would have any significant impact on diverse enrollment, and others felt it was little more than lip service.

“We are requiring implicit bias trainings and sending out emails about diversity without changing any policies or procedures,” one respondent said.

Several respondents said their sites are trying to improve this situation. One, for instance, said their site has done away with traditional requirements for employment, such as requiring a bachelor’s degree, in addition to making heavy investments in training diverse staff.

The survey also asked respondents about their current efforts to improve recruitment and retention of diverse study participants and how effective those methods were.

Almost all sites (95 percent) offered some form of participant compensation, typically cash, meals or lodging assistance. The majority (71.6 percent) felt these offerings were generally fair, except when participants had to take work leave to attend study visits — something more than 82 percent of participants had to do.

Not all respondents felt these gestures were adequate, however. About 60 percent said their site didn’t offer meals, snacks, or meal tickets, although 32 percent felt doing so would help increase diversity at their site. Most respondents (69.2 percent) said their site also didn’t offer free or subsidized lodging, even though 42 percent thought doing so would help improve cohort diversity.

Several respondent comments illustrated these frustrations.

“Practices from 2000 that were used to conduct ethical research are not adequate to conduct ethical research in 2022,” one respondent said. “A stipend of $75 is inappropriate for a pediatric subject to complete an invasive eight-hour study visit, including driving to the site, with both caregivers who both must take time off work and provide necessary arrangements for other family members in order to attend,” the person said.

Many sites were using decentralized clinical trial services, translations and flexible site hours to increase convenience for participants — but only about one-third of respondents (36 percent) felt strongly confident in those elements. And although virtually everyone agreed that providing translated study materials (such as patient education and consent forms) is the thing to do, only one-third of sites were doing it consistently. Another third did this sometimes, and the rest, never. Often, sites that did offer translations only provided the service after a participant had already been enrolled — it wasn’t a proactive approach.

Four key themes emerged among suggestions of how sponsors can improve the situation: Financial support, preplanned translated materials, more diverse marketing with community outreach and enhancing the diversity of study staff by supporting workforce development and education.

“Compensate the staff and families adequately with what is considered a living wage in the area of the study site,” one respondent recommended.

Concerns about coercing people into participating need to be reevaluated in today’s economic context, they added. “Evolve the term ‘coercive’ and check whether you are actually exploiting subjects by trying to avoid ‘coercive’ stipends. [Paying] $500 for an eight-hour visit plus driving two hours with a child is not coercive in today’s economic landscape. Compensate for time, lost wages, babysitting costs for other children, undergoing invasive procedures with potentially no benefit, transportation, food, lodging, mileage, etc.”

Solutions to many of these problems could be folded into the study design, some respondents felt.

“Building socioeconomic considerations into protocols and investigator budgets to increase resources to enhance diversity” would be a good step. Translating all study materials from the very beginning would be much more effective than doing it piecemeal, another suggested.

It’s also important to remember that a single solution might not serve all participants in a study.

“Most pharmaceutical sponsors provide travel reimbursements in the form of mileage and sometimes hotel reimbursements,” one respondent noted. “However, there are occasionally patients that are unable to drive themselves because they do not have a vehicle or are unable to find a family member or friend to drive them. Social workers are sometimes able to facilitate transportation, but patients are not always eligible.”

Tackling these issues won’t be easy but it will be necessary, MacLennan said. The analysis suggests that a multistakeholder approach, with all key players on board when study planning commences, is the key to enhancing diversity and inclusion.

In her view, leadership at the sponsor, CRO and site levels should have diversity plans ready to go before trials begin, with CRO and sponsor budgets taking these plans into consideration during the planning phase. In addition, planning should incorporate strategies that provide participant compensation, document translations, translator services and reimbursement for traveling, as the study found these offerings had the biggest impact on diverse enrollment, she wrote.

Read the full study here: https://bit.ly/3Yn1hTd.