June 9, 2022 – When asked about patient diversity in clinical trials, Diana Foster likes to reflect back to 2016. Foster, VP, strategy and special projects & diversity awareness program lead at the Society for Clinical Research Sites (SCRS), notes that was the year a group of individuals from approximately 40 organizations gathered in Washington D.C. to discuss diversity.

That was also the year Robert Califf, then commissioner of the FDA, declared 2016 to be the year of diversity.

“Christine Pierre (then head of SCRS) and I were in that room,” says Foster. “We realized we were the only representatives from the clinical trials industry who had focus on the research site perspective with insights on how sites would respond to what we were discussing and what their challenges and needs would be.”

ollowing the meeting, SCRS was approached by a sponsor company to kick off a diversity initiative to gain greater awareness of the issue from the site point of view. Merck and Janssen provided funding to support the initiative. SCRS was only four years old at the time but opted to make patient diversity and site sustainability a focus of the organization.

“At that point we decided we would not make assumptions about what sites may need and want,” states Foster. “We would conduct research to understand issues from the site perspective. We wanted insights from hundreds of sites, not just a handful. We developed an instrument called the Diversity Site Assessment Tool that is now being used as a benchmark in the industry to assess, for example, where individual sites stand with respect to best practices or the lack thereof.”

Sites Need Assistance

To help sites better understand diversity, SCRS has produced five research papers and is currently working on the sixth. Foster believes sites lack awareness of the issue, just like many in the industry. The goal of the papers is to raise the level of awareness and understanding.

“We have found that sites need guidance and a better understanding of best practices in diversity,” says Foster. “We chose to zero in on that topic to develop the gold standard of benchmarking so sites will know where they need to improve.”

SCRS now has a conference devoted to this topic, the Diversity Site Solutions Summit, which took place on May 20, 2022, in Austin. The conference drew over 300 individuals to take part in it. When Foster thinks about what sites need most, the first thing that comes to mind is knowledge and support.

“They need better awareness of what’s coming and the ability to understand FDA guidance on the issue,” notes Foster. “Sponsors will soon need to have diversity plans in place with diverse enrollment targets. They must plan and integrate diversity into their organizations and communicate it down to the sites responsible for enrolling patients.”

Today, Foster believes sites are in need of help. They will need budget dollars to support them. They need planning and education. And they are going to need training on how to develop a diverse staff and how to engage patients of all ethnicities and backgrounds around the world.

New Directions

Although the new FDA guidance discusses the creation of a diversity plan, it will take a collaborative effort to increase diversity numbers in trials. For starters, site training should be at the top of every sponsor company’s to do list. That training should discuss the meaning of diversity, what it means to enroll diverse patients, and how targets can be set.

Responsibility for assisting sites will not fall entirely on sponsor companies. If those companies are working with CROs, the CROs will also have a role to play.

“We all need to do more to increase the awareness and understanding of trials,” adds Foster. “A sizable percentage of people in the U.S. have never heard of a clinical trial, and unfortunately that lack of awareness has not changed much over the years.  We are still trying to increase that awareness while reaching out to individuals in more difficult to reach and underrepresented populations. We need to educate people on what clinical trials are and how they can participate in them. People need to hear that message.”

For more information on the Diversity Site Solutions Summit and SCRS Diversity Awareness Program visit: https://myscrs.org/diversity/

Clinical Trial Leader: “SCRS Puts A Spotlight on Diversity”