Episode 26: Harley Skorpenske – Optimizing Recruitment & Retention in Rheumatoid Arthritis Clinical Trials

Resources: 

• Busdev@innovaderm.com: Use this email to let us know what you want to hear about. 

Introducing Harley Skorpenske, a Clinical Research Associate II at Indero, whose vast expertise in clinical research includes a range of therapeutic areas, with a notable emphasis on dermatology and rheumatology. Harley’s innovative strategies for patient recruitment and retention have significantly contributed to the success of numerous clinical trials. 

In this article, we dive into the optimization of recruitment and retention in Rheumatoid Arthritis (RA) clinical trials, focusing on the following concepts:   

1. The challenges and considerations in recruiting participants 
2. The impact of seasonal and environmental factors 
3. Proven strategies to enhance recruitment and retention 

Recruitment Challenges and Considerations  

When recruiting RA patients for clinical trials, several obstacles must be considered. RA is a complex illness often accompanied by other conditions such as fibromyalgia, Sjögren’s syndrome, mixed connective tissue disease, and Raynaud’s phenomenon. These comorbidities can complicate the inclusion/exclusion criteria, making it challenging to find suitable participants who only have RA without other interfering illnesses. 

Socioeconomic barriers also play a significant role. Many RA patients face income loss or are on disability, which affects their ability to travel to and from the clinic. These patients often save their paid time off (PTO) for days when they feel particularly unwell, making it difficult to use PTO for clinic visits when they are feeling relatively okay. 

Additionally, patient caution is a critical factor. Those with advanced RA experience daily pain and may be hesitant to try new therapies. Their current arthritis management might not be optimal, but the fear of worsening symptoms makes them rely heavily on their rheumatologist’s advice before considering new treatments. 

Seasonal, Regional, and Environmental Influences 

Weather can significantly impact disease activity in RA patients. Cold weather sensitivity is a major challenge, often exacerbating pain for those living in colder climates or during winter months. Conversely, warmer weather or climates can have a positive effect, with patients experiencing looser joints and reporting lower incidences of pain. This phenomenon, sometimes referred to as the seasonal placebo effect, highlights the importance of considering environmental factors when managing RA symptoms and planning clinical trials.

Proven Strategies to Support Recruitment and Retention 

To enhance recruitment and retention in clinical trials, several strategies can be implemented: 

1. Protocol Design: A well-designed protocol can significantly boost recruitment. Offering an open-label extension period, where patients are assured of receiving the active medication after the investigational phase, can be highly enticing. Additionally, providing short-term rescue medication throughout the trial can reassure patients who are nervous about potential pain, especially if they might receive a placebo. 
2. Logistical and Financial Support: Ensuring patients receive reasonable compensation and reimbursement can alleviate participation burdens. This support is crucial for all clinical trials, not just those involving RA. 
3. Flexible Scheduling: Offering flexible scheduling options, such as evening and weekend appointments, can accommodate patients’ varying availability. This flexibility is particularly beneficial for those who may struggle to attend clinic visits during standard hours due to other commitments or health issues. 

Site-Level Best Practices for Patient Comfort and Accessibility  

Ensuring patient comfort and accessibility is key for those with RA, given the significant impact of pain. Here are some best practices: 

1. Facility Accessibility: Ensure the clinic is accessible on a large scale by providing ramps, wide hallways, and spacious bathrooms to accommodate walkers or wheelchairs. On a smaller scale, provide stools at the bottom of exam tables to help patients with RA get on and off easily. 
2. Patient-Friendly Amenities: Offer arthritis-friendly snacks and refreshments. For example, providing pre-opened soda cans or asking if assistance is needed can enhance hospitality and make patients feel more comfortable. 
3. Telehealth and Remote Monitoring: Implement telehealth visits and remote monitoring options, such as virtual visits and wearable technology. This approach reduces the need for frequent clinic visits and allows continuous data collection, benefiting both patients and long-term data analysis. 

Community and Relationship-Driven Recruitment 

The RA community is remarkable for its strong sense of connection and support among individuals living with life-altering illnesses. Patients often know others with RA, whether through official groups or casual friendships, providing valuable opportunities to share challenges and discover helpful “life hacks.” 

To leverage this community for recruitment and retention, we can encourage existing patients to refer others they know. This organic growth of study enrollment brings in more participants who trust the referring patient and, by extension, the study team. 

Additionally, partnering with larger advocacy groups and autoimmune disease organizations can enhance credibility and expand outreach. These trusted organizations can help reach patients who might not be part of the close-knit community. 

Providing informational materials for patients to take to their next rheumatology or medical team visits can also be beneficial. These materials enable patients to have informed conversations with their physicians, who can then offer their approval and support for trial participation. This specialist endorsement can be significant in encouraging patients to join the study. 

By fostering community connections and building trust through referrals and partnerships, we can effectively enhance recruitment and retention in RA clinical trials. 

Building Patient Trust Through Communication and Education 

Establishing patient trust is primordial for all clinical trials, not just those involving RA. Transparent communication is key, starting with the consent form. Instead of having patients read it alone, sit with them to clearly outline the purpose, risks, and benefits of participation. This approach fosters a comfortable, casual discourse and encourages natural questions, empowering patients to make informed decisions. 

Continuing this transparent communication throughout the study is essential. Provide ongoing updates, not just through official consent forms, but through regular conversations during clinic visits or outreach calls. Ensuring patients feel informed and comfortable throughout the study fosters engagement and encourages them to reach out proactively. This increased compliance helps ensure patients attend all visits, take their medication, and ultimately reduces the withdrawal rate from the trial. 

As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time. 

Let’s shape the future of research and make a difference in the industry, gain Indero’s support in your upcoming trial and propel your study to new heights.