Federal work policies are not the typical focus of patient advocacy groups. But when the Foundation for Sarcoidosis Research dug into the challenges patients face with staying in clinical trials, the solutions were too obvious to ignore.
It all started when the organization turned to its patient community for insights about the clinical trial journey.
A rare inflammatory disease, sarcoidosis disproportionately impacts Black Americans, who are 12 times more likely to die from the condition than the general population.
“It’s really significant, so that was a catalyst for us … to learn how it’s impacting this community,” said Tricha Shivas, chief of staff and strategy at FSR.
The organization surveyed about 400 patients last year and then met with industry leaders to learn more about representation in clinical trials. Ultimately, the efforts pinpointed several key issues such as doctors not informing patients about trials and the challenge of getting time off from work to participate in research.
“One clinician told us about a patient enrolled in a study but had to spend three to four hours of her day to be in the trial. So her company told her she’d have to drop out of the study or lose her job,” Shivas recalled. “Then it became about: How do we stop talking about barriers and actually make change?”
The linchpin to one solution was the Family and Medical Leave Act. Because the policy’s language only allowed for time off to receive “treatments” for a medical condition, employees couldn’t leverage it for clinical trials, which often administer placebos. But after lobbying the Department of Labor, FSR got word last year that regulators were on board to switch the language and account for clinical trials.
“We see these systemic changes as being a part of our mission now."
Tricha Shivas
Chief of staff and strategy, FSR
The win reverberated beyond the sarcoidosis community to all participants in U.S. clinical trials. FSR’s policy score also showcased the role patient groups can play in overcoming obstacles to representation in research.
That role has gotten more important this year. Although pharma has invested heavily in boosting clinical trial diversity in recent years, broad anti-DEI measures by the Trump administration have sent mixed signals over regulators’ ongoing support.
“Advocacy groups are uniquely positioned to understand and speak for patients,” Shivas said.
Now, the focus is on building that momentum to drive sarcoidosis R&D while broadening clinical trial access and diversity for pharma as a whole.
Sarcoidosis and beyond
Like many patient organizations, FSR dedicates much of its resources to bolstering drug development. Although FSR doesn’t lead R&D funding efforts for sarcoidosis, the group tracks progress in pharma’s pipeline and helps funnel patients into studies for new drugs.
A research agenda published this year by FSR also pointed to top priorities for scientists, including the need to find more biomarkers and diagnostic techniques. Because sarcoidosis can affect multiple systems and organs, the disease often presents with a constellation of symptoms that can flare up and fade over time, making it a “very hard disease to diagnose,” Shivas said.
Advances on those fronts will also set the stage for more drug innovations.
The first-line treatment for sarcoidosis is generally steroids, which come with an array of difficult side effects. The drugs also carry comorbidities for the Black community who are already at a higher risk for illnesses associated with steroid use including heart disease and diabetes.
Now, about a dozen new drugs and assays are being tested in clinical trials, Shivas said, and the pipeline includes several innovative approaches such as JAK inhibitors.
One potentially impactful readout is expected later this year from aTyr Pharma, which plans to publish phase 3 results for efzofitimod, a first-in-class biologic immunomodulator, in pulmonary sarcoidosis.
Meanwhile, the other pillars of FSR’s current work could have ripple effects beyond the sarcoidosis community.
The organization’s Coalition to Transform Clinical Trial Engagement has strung together dozens of industry stakeholders, including pharma, research and healthcare companies, along with leading bioethicists such as Arthur Caplan, to address research disparities in the Black community.
The coalition is aiming to make policy recommendations that break down barriers such as clinical trial compensation.
Last month, it also launched Champions for Change, an initiative encouraging corporations to offer paid time off for employees who want to participate in clinical research.
As a mature organization that’s been around for 25 years with a key regulatory win under its belt, Shivas said FSR will continue to keep its eye on large prizes that bolster the entire industry.
“We see these systemic changes as being a part of our mission now,” Shivas said. “We’re not just calling out problems, but identifying actionable changes.”
