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Clinical trials are the backbone of life science treatments, providing the data needed to deliver new & innovative therapies to market. However, recruiting participants for these trials is a persistent challenge, particularly when it comes to rare disease studies. Patient Advocacy Strategies explores proven, data-driven strategies for improving recruitment and retention through patient advocacy partnerships and engagement.

Written by Mike Walsh, founder and CEO; Patient Advocacy Strategies

The recruitment challenge in clinical trials

Recruiting participants for clinical trials is notoriously difficult. Many studies struggle to find a sufficient number of eligible trial participants, leading to delays and increased costs. This issue is dramatically exacerbated in rare disease studies, where patient populations are small and geographically dispersed, with low disease awareness. The rarer the disease, the harder it is to find the patients who meet the specific criteria needed for a study in a timeframe that meets the sponsor’s study timeline.

Limitations of traditional recruitment methods

Contract Research Organisations (CROs) are often employed to manage recruitment efforts. However, they frequently fall short in rare disease trials due to their reliance on conventional recruitment strategies that may not resonate with niche and high-touch patient communities. This inefficiency can result in prolonged timelines and unmet recruitment targets.

The power and value of early patient engagement

One proactive and effective approach to address these challenges is forging authentic partnerships with patients from the earliest stages of drug development, before the studies begin. Engaging patients at the pre-clinical stage to inform the study helps ensure that trials are designed with their needs embedded in the study endpoints and overall design. Crafting a ‘right-sized’ trial, informed by the very patient communities the study seeks to enroll sets R&D programs up for better success. Engaging the community in the process from the start builds trust with patients and which has been proved to lead to accelerated enrolment and better retention rates.

Enlisting the support of patients and integrating their insights through focus groups, surveys and 1:1 interviews with sponsors has proven to serve as an effective validation exercise to ensure the trial conducted with their condition is poised to meet their needs. These sustainable partnerships  have proven to earns trust with targeted patient advocates and their communities. This trust is critical to long-term success as a programme progresses toward commercial launch. Aligning with patients early enables a trusted army of champions for science who will amplify study awareness, celebrate data readouts, and support regulatory strategies and activity.

As highlighted in an article published in the Therapeutic Innovation & Regulatory Science Journal by Dr. Bennet Levitan and Dr. Kenneth Getz, MBA, Executive Director and Professor of the Tufts Center for the Study of Drug Development, early engagement with patient communities resulted in the avoidance of protocol amendments and other delays. The authors looked at a $100,000 investment in patient activities to inform the trial, including patient advisory panels, patient experience surveys, and trial awareness educational resources. The study found that the impact of such partnerships with patients led to a greater than 500X return on investment due to trials staying on schedule, avoiding time-sensitive amendments and accelerated regulatory approval.

Patient advocacy strategies (PAS) can help

Patient Advocacy Strategies (PAS) plays a crucial role in bridging the gap between life science companies and patient communities. By harmonising engagement efforts and amplifying the patient voice, PAS helps create actionable insights that benefit both patients and biopharma companies. Here’s how PAS works:

• Community engagement: PAS builds trusted, high-touch relationships with patient advocacy groups, individual patients and other stakeholders to ensure their perspectives are integrated into trial design and execution.
• Patient-centric trial design: By focusing on patients’ needs and preferences, PAS enables sponsors the ability to design trials that are more impactful and accessible to potential participants.
• Effective communication strategies: Tailored messaging and outreach educational campaigns informed by patients, improves awareness and understanding of clinical trials among target populations.
• Co-developed educational content: Working with the very patients your study is targeting, we create live action patient story videos and a litany of other educational resources that speak to patients to elevate awareness, accelerate enrolment and strengthen retention to optimise study design and drive study success.

Delivering value to patients and sponsors

The strategies employed by PAS enhance recruitment and deliver significant value to patients and sponsors. Patients benefit from trials that are more aligned with their needs and priorities, while sponsors see improved trial outcomes and an army of champions compelled to amplify R&D milestones, organically, deep into their communities.

Get involved: do it the right way. Partner with us

If you’re interested in learning more about how Patient Advocacy Strategies can optimise your clinical trial efforts, we invite you to reach out for more information. Together, we can create a more inclusive and right-sized clinical trial strategy that satisfies the needs of all stakeholders.

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