How to Conduct Patient Recruitment Feasibility Research at Your Site

Your site has been chosen as a location for a clinical trial – that's great news. But if you're already well aware that 11% of research sites fail to recruit a single patient, you may be feeling more stressed than excited about the whole process.

Ideally, the sponsor for your trial already conducted patient recruitment feasibility studies to make sure your site was right for the trial. But before your team starts a recruitment plan, it's important to understand the target clinical trial recruitment rate, and know where your site fits in. Then, analyze your site's resources and identify possible recruitment challenges that could crop up along the way. From there, you can develop a recruitment plan that's catered to the specific needs of your site.

Step 1: Understand your site's resources.

First, take inventory of the resources you'll have at your site to support patient recruitment. Often, a study coordinator may be tasked with putting together a plan, but your site may also have a marketing team or recruitment specialist who will be involved, too. If your staff resources are limited, consider enlisting the help of a patient recruitment company. Think about needs beyond setting up ads, as well, if you're going to conduct screening over the phone. You'll also need someone to answer patient questions during recruitment.

Step 2: Evaluate your existing database.

If your site already has a patient database, take time to thoroughly review it. How long has it been since patients have been contacted? Approximately how many eligible patients are in your database? If the contact information you have is on the older side, email addresses, phone numbers, and the patient's treatment information may be out of date. Consider the inclusion and exclusion criteria for your trial, too, and how that might impact the eligibility for patients in your database. Knowing how many patients you already have access to can help you better understand additional needs and allocate budget accordingly, whether to working with an agency or to your own advertising spend.

Step 3: Learn about your patient population.

Ideally, the trial sponsor already analyzed the patient population in your area before selecting your site. It's still important for individual sites to conduct their own research, too. Visit message boards, blogs, and disease nonprofit websites to better understand patient needs. You can also get a sense of whether there may be mistrust around clinical research, or on the flip side, excitement around getting involved. As you get to know your patient population, you can also start to think about potential advertising channels that will be appropriate for reaching these patients.

Step 4: Connect with local partners.

Besides using the patient database your site already has, local nonprofits and patient groups can also offer lower-cost options for reaching patients. Your site may be able to take part in local health fairs, fundraising walks, or other events specific to your trial's condition area. Some recruitment companies also partner with organizations that are involved in educating patients about clinical trial opportunities, too.

Step 5: What retention tools can you use to keep patients engaged?

Unfortunately, up to 30% of patients drop out in the course of a clinical trial. As you start to create your recruitment plan, it's helpful to develop a retention strategy alongside it. Does your site currently have tools to create an email newsletter or text messages to help keep patients engaged throughout your trial? Do you have the staff power to answer questions from patients during the trial, in between visits? Identifying gaps in staffing and other potential challenges early on can help your site prepare for recruitment and retention needs once the trial launches.

Hopefully, your site's personal feasibility check will reveal that you're actually in good shape for your trial. And if following these steps revealed any issues, planning ahead means you have time to find a solution before recruitment delays slow down your trial.

Looking for more guidance on how to reach patients? Download our free advertising e-book for advice and examples on how to engage patients while sticking to FDA guidelines, too.