Patient Advocacy Group Leads the Charge for Federal Policy Change in Clinical Trials
Federal work policies are not typically the focus of patient advocacy groups, but when the Foundation for Sarcoidosis Research (FSR) delved into the challenges faced by patients participating in clinical trials, the need for change became too evident to ignore.
The journey began when FSR reached out to its patient community for insights into the clinical trial process. Sarcoidosis, a rare inflammatory disease, disproportionately affects Black Americans, who are 12 times more likely to succumb to the condition than the general population.
Tricha Shivas, Chief of Staff and Strategy at FSR, emphasized the significance of understanding how sarcoidosis impacts this community. Through surveys and industry meetings, FSR identified key issues such as lack of information from doctors about trials and the difficulty of taking time off work to participate in research.
One poignant example highlighted a patient who risked losing her job because she had to spend hours each day participating in a trial. This led FSR to advocate for a change in the Family and Medical Leave Act (FMLA) to include time off for clinical trials. After successful lobbying efforts, the Department of Labor agreed to amend the policy, allowing patients to take leave for trial participation.
The impact of this victory extended beyond the sarcoidosis community, demonstrating the pivotal role patient advocacy groups can play in addressing barriers to diversity and representation in clinical trials. Despite challenges presented by changing federal policies, advocacy groups like FSR remain essential in advocating for patient needs.
Looking ahead, FSR continues to focus on advancing sarcoidosis research and expanding access to clinical trials for all patients. By monitoring drug development progress and prioritizing research initiatives, FSR aims to drive innovation in treatment options for sarcoidosis.
With several new drugs and assays in clinical trials, including promising approaches like JAK inhibitors, the landscape of sarcoidosis treatment is evolving. Additionally, collaborations through initiatives like the Coalition to Transform Clinical Trial Engagement are working to address research disparities and improve access to trials for underrepresented communities.
FSR’s commitment to systemic change and advocacy for patients underscores the organization’s mission to drive meaningful impact in the healthcare industry. By championing policy recommendations and initiatives like Champions for Change, FSR is paving the way for a more inclusive and patient-centered approach to clinical research.
In conclusion, FSR’s regulatory win and ongoing efforts reflect a dedication to driving positive change in the healthcare landscape. As a seasoned organization with a track record of success, FSR remains steadfast in its mission to identify and implement actionable changes that benefit patients and the industry as a whole.
