Gaining Participation in Clinical Trials

by Colleen Moore, January 2022

When it comes to patient recruitment and retention for clinical trials, the bottom line is simply this: It is important and challenging in all scenarios… the difference is in how significant the focus and effort will need to be.

As this article suggests, identifying, engaging, and retaining appropriate patients for clinical trials can be extremely demanding and costly. And that was even before the pandemic and its related complexities. Things get even more difficult in the case of rare diseases, where the number of eligible patients is severely limited, and the channels through which patients can connect with a clinical trial can be difficult to navigate.

Overall, we have found that developing a multi-channel and cross-stakeholder plan that will support patient recruitment from different perspectives can benefit companies undertaking clinical trials.

A few recommendations follow based on our experiences across several client engagements and circumstances. It is not intended to be an exhaustive roadmap but, rather, a top-down look at what we have seen to be effective when we collaborate with the cross-functional teams within our client organizations.

Assess the Disease Area

Who are these patients, and what are their needs? Gaining insight into patient demographics and general level of health vis a vis the trial protocol will inform how the trial is designed, how participants are recruited, and the support that patients and their families may value.

For example, are they older adults with comorbidities, transportation challenges, and unfamiliarity with technology? Or are they a pediatric population with parents, siblings, and ongoing school requirements? The demographic characteristics of the patient population will dictate the approach required.

Additionally, it’s important to consider the current treatment landscape and patient journey. How many others have the disease, where do they get treatment, what is the standard of care, how many competitive trials are already in place? All of this will inform how you reach patients and what may be offered to attract the right people and keep them involved.

Partner and Collaborate

We suggest conducting a review of the relevant patient advocacy groups, associations, and other stakeholder groups, to identify sources of support, outreach, information, and education for patients and caregivers. Although outside firms can do this, it is also possible to create the first pass list of these groups internally. (Building a plan to engage with the groups and ensure commitments are kept is a topic for another time.)

Patient advocacy groups — from small, regional, disease-specific organizations to global associations — are key partners in patient identification and recruitment. They also ensure that the patient voice and experience are consistently reflected in trial design and implementation. With rare diseases, in particular, advocacy groups pave the way. They are intimately involved with the population and can guide you in finding patients, communicating with them, and clarifying what they care about most.

Identify Potential Specialized Partners

Many firms are focused on clinical trial recruitment, which can help to build awareness of the studies and develop specific recommendations for the internal team on how best to increase enrollment. A wide range of programs can be implemented at all budget levels.

Options range from developing patient brochures and study-specific websites to drive awareness, to targeted communications to referrers and other HCPs. Broader, direct-to-patient campaigns using social and traditional media can also be part of the mix.

However, keep in mind that while you may outsource aspects of recruitment implementation, you want to own the conversation internally about how to find and engage the people you need. Not only will this improve the outcome of the current trial, but the insights gathered, and first-hand analysis can be leveraged for other company trials in the future.

Right-Size Your Approach and Timing

Overall, it is important to identify what makes sense for this particular trial and patient population and that the approach is tailored to the company’s specific needs, budget, and constraints.

Further, we often suggest a phased approach — time permitting — where different programs are introduced sequentially so the impact can be assessed and refined before a new approach is undertaken. We recognize the need for speed, however, companies often stumble when launching too many efforts at once.

Final Thoughts

Putting the patient at the center of clinical trial design and implementation yields many benefits. Not just for patients and their caregivers who are searching for promising options, but also for the company itself.

Remaining sensitive to patients’ experiences and concerns and striving to minimize the challenges associated with clinical trial participation, can enable companies to achieve their trial recruitment and retention objectives. It is essential that each patient has a positive experience throughout the course of the trial. Adopting a cross-functional, integrated approach for tackling this critical objective can help ensure that a variety of viewpoints and capabilities are brought to bear.

Above all, it’s important to remember that there is more going on here than just the operation of the trial and the clinical sites; eager and engaged participants are necessary to make all of this work. By keeping in mind who is at the center, what they need, why they need it, and what our resources are for doing it, we maximize positive outcomes for all involved.

Posted in All Categories, Decision-Making and Process, Strategy and Planning