The evolving rheumatology patient in clinical trials

Recruitment is becoming increasingly challenging for rheumatology clinical trials due to the rising number of informed and treatment-experienced patients. Many have access to well-established standards of care and carefully weigh the benefits of trial participation before enrolling.

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At the same time, complex care pathways and the burden of chronic disease can have a significant impact on recruitment and retention. This article explores Indero's research into how evolving patient experiences are reshaping clinical trial participation and discusses how sponsors can better align study design with patient needs to improve engagement and outcomes in rheumatology studies.

Today’s rheumatology patients have changed

Recruiting participants for rheumatology clinical trials can be challenging. In contrast to those in some other therapeutic areas, rheumatology studies rely on patients who are often not new to treatment. In many cases, they will have been living with their condition for years and will have experienced multiple therapies.

They are likely to be living with comorbidities, and are often tired of cycling through different treatment regimens and frustrated with the healthcare system. As patients who already have access to established standards of care, they are frequently skeptical about joining a trial; participation is often a choice rather than a necessity.

Today, patients are also increasingly well-informed about their condition and treatment options, and this shapes how they evaluate clinical trials.

Clinical trials often require patients to decrease their dosages of current treatments that provide day-to-day control of their condition. Patients, therefore, may be wary of participating in such trials when they may receive a placebo rather than the novel drug itself.

Complex care pathways create recruitment challenges

This situation can be complicated by the fact that rheumatology care pathways are usually complex, with patients presenting with a variety of symptoms and potentially receiving care from healthcare professionals in several different disciplines, including rheumatology, primary care, pain management, gastroenterology, dermatology, and even emergency care in the event of a flare-up.

In the US, this is compounded by a shortage of rheumatologists. The involvement of multiple care pathways poses a challenge for patient recruitment; strategies focused solely on rheumatology specialists may miss eligible patients.

This is why trial sponsors often work with contract research organizations (CROs) to not only provide rheumatology expertise, but also to identify other patient pathways that offer potential recruitment opportunities.

There is a clear need to think more creatively about the routes patients follow when establishing a referral system, to make sure that all relevant healthcare sectors are aware of the trial and its eligibility criteria. CROs can strengthen patient engagement by building relationships not only with investigators and doctors, but also with patient advocacy groups (PAGs) that can connect patients with appropriate clinical trial sites.

The burden of chronic disease can impact participation

Pain, fatigue, mobility issues, travel requirements and related costs, visit schedules, and the need for caregiver support also all have a significant impact on patient participation in rheumatology trials. Therefore, practical support is crucial to successful recruitment and retention.

For example, a travel concierge can handle travel arrangements for patients; comfort materials can be provided for long site visits; patients’ out-of-pocket expenses, such as parking and taxi costs, can be covered; and the need for support can be addressed.

Understanding the challenges from a patient’s perspective and addressing them early on can create a more practical, patient-friendly trial experience that is more attractive to potential participants.

Participation depends on perceived value

For patients, deciding whether or not to join a trial is usually a case of weighing the potential benefits against the time and effort required, taking into consideration the possibility that they may receive a placebo, and balancing the potential relief and the overall benefit to people living with their condition against the practical demands of participation.

Clear communication channels and patient-centered trial experiences are essential for improving engagement. Open-label extensions may also contribute to the overall value proposition for some participants, providing an opportunity to receive the active treatment after the controlled study period.

Aligning trial design with patient needs

Patient insights should inform the study design from the outset; reducing the burden of participation and improving convenience are key for effective recruitment and retention.

One encouraging trend is the inclusion of patient research partners (PRPs) in reviewing and providing feedback on trial protocols. CROs with rheumatology expertise can help sponsors navigate the recruitment pathway by identifying patient considerations during the early stages so that they can be addressed when designing the trial protocol and during operational planning.

An ever-changing landscape

The rheumatology care and recruitment landscape in clinical trials continues to evolve, and successful strategies need to reflect real-world patient pathways and experiences rather than relying on traditional assumptions about where rheumatology patients receive care.

CROs with rheumatology expertise can help study teams identify suitable individuals and develop more patient-centered approaches to recruitment and participation. By understanding patients’ treatment expectations and practical needs, sponsors can make studies more attractive and participation more manageable, helping to improve engagement, retention, and overall study outcomes.

Acknowledgments

Produced using materials originally authored by John Clarke, Associate Director, Patient Recruitment, Indero.

About Indero

Indero is a dual-focus CRO for dermatology and rheumatology, with over 25 years of experience in clinical research and trial delivery. Our full-service approach, which includes everything from protocol design and patient recruitment to trial monitoring and biometrics, provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Latin America, and Asia-Pacific; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal partner for clinical needs at a global scale. 

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