Social distancing. Fear of infection. Major life disruptions. For most, these concerns are new, and related directly to COVID-19. But for people living with autoimmune diseases like lupus, RA, Crohn’s and colitis, these concerns are present every day. Even so, autoimmune patients have historically been willing to participate in clinical research despite the risks.
But without widespread testing and a vaccine (and perhaps even then) everyone, every activity, every surface remains potentially threatening to these patients—that could have a direct impact on their willingness to enroll in a clinical trial. Due to their increased risk of infection, autoimmune patients may feel more uncomfortable going “back to normal.”
The New Rules of Recruitment
As enrollment resumes, sponsors and their CROs will have to navigate many challenges to deliver clinical trials in a patient-centric way. Each aspect of patient recruitment and clinical trial implementation must be viewed through the lens of the autoimmune patient’s heightened state of concern. In a survey conducted by Continuum and the ACRP, 60% of sites who conduct autoimmune trials say their patients strongly desire maintaining social distance, and more than half are unwilling to visit a study site. Overcoming these challenges—and communicating clearly what steps are being taken to ensure their safety—is crucial to enrollment and retention in these trials moving forward.
Site Visits
The first thing patients will need to feel comfortable with is their safety during visits to the study site. Many sites have put new hygiene protocols in place, and for sites conducting autoimmune trials, communicating these precautions to their autoimmune patients will go a long way in helping patients feel more confident attending a study visit. It may even be in the sponsor’s best interest to provide study site personnel and participants with PPE as part of each study visit to further protect them from possible infection.
Home Visits
COVID-19 has propelled our industry forward in terms of figuring out how to accommodate home health visits when possible, with the FDA outlining best practices in the US guidance. But challenges remain with implementing many of the required procedures. In instances where an LPN cannot perform the duties in compliance with state regulations, specific equipment (e.g., transportation, blood sample collection and storage, and required registrations) requirements may make home health visits extremely challenging. Because sponsors are (rightly) concerned with consistency in data, many sponsors or CROs require the services be conducted by a specific company that may not have a presence in all states or countries. Autoimmune patients may not even be willing to agree to home visits: our research indicates only 28% of sites who work with immunocompromised patients said those patients would permit in-home visits from clinical trial staff.
Outreach
Many autoimmune patients have made a change in their media consumption since the news cycle is dominated by COVID-19. Particularly since much of the communication reminds them that they are at “highest risk”—something they are already painfully aware of—many patients have narrowed the channels they turn to for media, so carefully selecting channels for outreach will be very important. Messaging, too, must be more customized than ever, working to motivate their participation while acknowledging some of their obvious concerns. Patient advocacy groups, already a trusted source of information in autoimmune communities, may become even more important in reaching patients with clinical trial information. Influencers and bloggers, likewise, may prove Increasingly relevant.
A Renewed Focus on Patient-centricity
Enrolling and retaining patients with autoimmune conditions in clinical trials will remain a challenge for biopharma for the foreseeable future. The best way to continue to fully enroll trials on time is to renew our focus on patient-centricity. Gathering patient insights will be critical in order to develop effective study communications and in understanding changes to the attitudes, behaviors and primary motivators of patients with autoimmune disease, such as lupus, RA, Crohn’s or colitis. These attitudes and behaviors will continue to evolve as stay at home orders begin to loosen—and patients with an autoimmune disease continue to experience a heightened concern about their health and safety. All study communications must consistently convey empathy and understanding if they are to be successful.
Sponsors and their patient recruitment partners will have to expand their partnerships in order to effectively reach these patients in a way that is empathetic and effective, from outreach through site communications with patients.
