Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

The US Food and Drug Administration wants to see more diversity in the patient advocacy groups and community organizations with which biopharma sponsors engage as they develop and implement clinical trial diversity plans.

With almost two years of reviewing diversity plans under its belt, the FDA’s oncology review staff is concerned that sponsors are not doing enough to ensure diversity in the entities from whom they seek help in creating such plans, agency officials said during a session at the American Association for Cancer Research annual meeting in San Diego.

The FDA wants industry “to reach out to community organizations, and I believe industry has the resources to help do this. But what our concern is now two years out, is this really happening?” said Asma Dilawari, an FDA clinical reviewer in the Division of Oncology 1. “What is the best way to ensure that patient advocates, and not just certain patient advocates but a lot of patient advocates, are coming to the table?

LGBTQ Considerations

The FDA has been reviewing diversity plans submitted under an April 2022 guidance, which recommended that sponsors submit race and ethnicity diversity plans to enroll representative numbers of participants from historically under-represented populations. (Also see "FDA Draft Guidance Takes Aim At Racial, Ethnic Disparities In Clinical Trials" - Medtech Insight, 13 Apr, 2022.)

Under the Food and Drug Omnibus Reform Act, which was signed into law in December 2022, drug sponsors are required to submit diversity action plans for Phase III or other pivotal studies. The plans should include the sponsor’s goals for enrollment and supporting rationale, and an explanation of how they intend to meet those goals. (Also see "Legal Expert Weighs In On New US Mandate To Diversify Clinical Trials" - Medtech Insight, 3 Feb, 2023.)

For FDORA-required diversity action plans, “there are discussions about how to expand these patient groups and consider genders and involve the LGBTQ community as well.” – Asma Dilawari

The diversity action plans required under FDORA go beyond race and ethnicity, as recommended in the April 2022 guidance, to also include enrollment by age group, sex and potentially other demographic characteristics.

“There are discussions about how to expand these patient groups and consider genders and involve the LGBTQ community as well,” Dilawari said.

These considerations could explain why the FDA is overdue in issuing guidance on diversity action plans under FDORA, which had required new or revised draft guidance by the end of December 2023.  (Also see "FDA 2024: Watch For Trial-Diversity Guidance, Final Quality Systems Rewrite" - Medtech Insight, 9 Oct, 2023.)

Most of the diversity plans submitted under the April 2022 guidance have been in oncology, and the Oncology Center of Excellence has published a summary of the first year (April 2022 to April 2023) of plans submitted to the Center for Drug Evaluation and Research’s oncology review divisions.  (Also see "Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says" - Pink Sheet, 2 Dec, 2023.)

Since April 2023, approximately 100 more diversity plans have been submitted in oncology, Dilawari said. While there were considerations of race and ethnicity in those plans, almost none mentioned age or highlighted age groups, she said, noting the agency expects this to change with the FDORA legislation.

Broadening The Net

During the panel discussion, Dilawari said she was concerned to hear about patient advocacy groups and community-based organizations who had never been contacted by sponsors for their input on diversity plan development and implementation.

Medha Deoras-Sutliff, a consultant with the Metastatic Breast Cancer Alliance, said she has not been asked to be part of developing diversity action plans as an advocate, and the organizations with which she has been involved also have not been part of those conversations.

Professionally, Deoras-Sutliff works as a consultant on clinical trials, and her clients are “creating plans and planning for resources and budgeting to do the outreach and to provide introduction to the appropriate groups that can help, so I'm able to combine the advocacy with the consulting and drive it from that end,” she said.

“I think what we're also seeing potentially is the same operational challenge that we see where sponsors may go to the same academic research institutes to do their clinical research. We may see that sponsors are going to the same target patient advocacy groups.” – Genentech’s Bea Lavery

“But I think we're missing communication, because the plans for the sponsors do specifically say reach out to advocates and advocacy organizations, but it doesn't say what do you want them to do. What are some specific strategic actions you're expecting? What is the accountability on that?”

Session moderator Bea Lavery, VP-portfolio strategy lead in product development regulatory at Genentech, Inc., suggested sponsors are prone to repeatedly consulting the same entities.

“I think what we're also seeing potentially is the same operational challenge that we see where sponsors may go to the same academic research institutes to do their clinical research. We may see that sponsors are going to the same target patient advocacy groups, and I think this is a … call to action for everyone [to] help us with this awareness,” she said. “How do we then put pressure on industry to broaden its net?”

An Army Of Advocates

Deoras-Sutliff said it is important to include from the outset a diverse group of trained patient advocates, particularly those that understand the lived experience of the person to whom they are talking.

“It is not hard to find people that look like the patients that we want to take advantage of clinical trials research,” Deoras-Sutliff said. “There is an army in this country of patient advocates that are more than willing to step up with no compensation, although I would argue there should be some compensation for patient advocates.”

“I strongly encourage trial sponsors, the FDA, to look to the established patient advocacy organizations, the regional and national level,” she said. “Get the big picture.”

Every nonprofit, charitable organization “in every cancer type is deeply connected to the patient community and to the advocates,” she said. “We have patient organizations that can bring you 5, 10, 15 advocates around the country to communicate with a literacy level that works for the person they're talking to. They are trained, so you're not just releasing patients talking about their personal experience. They are there to advocate on behalf of others. So I strongly recommend if there are sponsors here or when you guys talk to trial sponsors, have they connected to the leading lung, prostate, kidney, melanoma, breast cancer … national organizations?”

More Digging Required

Speaking from the audience, FDA OCE Deputy Director Paul Kluetz reiterated the need to have diversity within the advocacy groups leveraged by sponsors.

“I see on panels not infrequently advocates that have PhDs, advocates that have MPHs, advocates that are certainly in middle- to high-income socio-economic classes,” Kluetz said.

“What are we doing to bring advocates in from those lower socio-economic groups across races, and also different educational levels as well as different ages? I want to see young people, middle-aged people and older people.” – FDA’s Paul Kluetz

Sponsors need to find people who can get into communities where people currently have no voice, he said. “What are we doing to bring advocates in from those lower socio-economic groups across races, and also different educational levels as well as different ages? I want to see young people, middle-aged people and older people.”

“In thinking about patient advocacy organizations, as a company you sometimes have to do some additional digging,” said Camille Pope, chief medical lead at Acclinate, a digital health company that leverages community engagement and trust-enabling technology to improve diversity and representation in clinical trials.

“There may be patient advocacy groups that focus just on that particular demographic,” she said, citing as an example the work of the Prostate Health Education Network, which focuses on Black men at all levels of education, literacy and age who have prostate cancer.

“It might be going beyond the standard patient advocacy groups that you're used to funding and partnering with and doing some additional digging.”