The Patient Advocates for Lupus Studies, or “PALS,” program was created by the Lupus Research Alliance and its affiliate Lupus Therapeutics (LT) to improve clinical trial awareness, knowledge, and enrollment among people living with lupus, with a specific focus on reaching diverse populations. The program is part of our commitment to identify and accelerate the development of new lupus treatments through the Lupus Clinical Investigators Network (LuCIN) and to engage people with lupus in various stages of clinical research. Individuals living with lupus who ideally have personal experience with clinical trials will receive training to serve as peer advocates for clinical trials at selected LuCIN centers.
The PALS program is a peer-to-peer clinical trials education program, through which education about lupus clinical trials will be delivered to patients by trained patient advocates, or “PALS,” who ideally have personal experience with lupus clinical trials. These individuals will receive formal training in basic lupus terminology, the clinical research process, and the importance of representative patient participation in clinical trials in order to address patient concerns related to clinical trials. The PALS will provide an additional, trial-agnostic resource for individuals with lupus who are considering enrolling in or want to learn more about clinical trials.
Through peer-to-peer support with an individual who understands the challenges of living with lupus and has had experience with clinical trials, the PALS program will provide clinical trial education with the goal of creating awareness about clinical trials for lupus, changing perceptions of clinical trials, and improving knowledge about the importance of clinical trials.
Lupus clinical trials have historically been difficult to enroll and often lack the diversity of the most affected population. Lack of diversity in clinical trial participation is not restricted to the lupus community, but rather is an issue that permeates the research field and has critical implications for understanding drug mechanisms and ultimately for health outcomes. Currently minority populations and women are underrepresented in clinical trials across multiple diseases. Given that women of color are at greatest risk for lupus and often experience a more severe form of the disease, it is essential that they are represented in clinical trials to find widely effective treatments.
There are many known barriers to clinical trial enrollment, including a lack of or misinformation regarding clinical trials, concerns about risks and benefits of untested medicines, and lack of opportunity. Second only to receiving clinical trial information from a member of their healthcare team, patients are interested in speaking with a peer who has participated in a clinical trial. This ability to speak with a peer regarding his/her experience with clinical trials provides the patient with a firsthand account of what participating in a clinical trial is like and gives the patient an additional opportunity to ask questions regarding clinical trial participation.
The goal of the program is:
- To have a greater and more diverse population of lupus patients be aware of, have positive attitudes towards, and ultimately participating in lupus clinical trials.
- This increased participation in clinical research will ideally lead to treatments that improve health outcomes and the quality of life for people living with lupus.
Five academic medical centers in the United States that serve diverse populations were selected to pilot the program. The centers are:
- Columbia University in New York City, New York
- University of Mississippi in Jackson, Mississippi
- University of North Carolina in Chapel Hill, North Carolina
- Emory University in Atlanta, Georgia
- Northwestern University in Chicago, Illinois
Currently, the program is in its pilot-testing phase at the five mentioned academic medical centers. Our hope is to expand the program to more LuCIN centers in the future in which case we will be looking for more individuals with clinical trial experience to serve as PALS. In the meantime, you can learn more about lupus clinical trials at lupustrials.org.