Investigator Initiated Trials: Common Recruitment Oversights & Effective Corrective Actions

One of the biggest challenges in launching an IIT is securing enough study participants. While many university clinic offices might have an affiliation with the local health system and can recruit patients directly, depending on the condition or treatment, they still need to focus on recruitment efforts for successful trial execution. For example, a 2019 report showed that less than 10% of people with cancer in the US participate in trials. This makes recruitment a key issue for IITs, much in the same way it is for their clinical trial office counterparts.  Understanding common oversights and corrective actions in recruiting is critical information for your research team and can mean the difference between trial success or failure. 

Recruiting outreach that assumes a certain level of patient understanding.  

You might lose a great candidate if you don’t describe the condition or topic in question at least a little—such as common symptoms. They may know it by another name, or they may have symptoms but no knowledge of what it is. Your advertising for participating in the trial should include photos or links to a website with more information. To refine your messaging, visit church groups, community centers and volunteer organizations for feedback. They likely have perspectives you haven’t considered—and they can help you tailor your communication to reach your target audience. This is especially important if you want a participant pool that is diverse by race, ethnicity, age, sex or other factors. Showing up in person, answering questions directly and honestly, also boosts the study’s credibility. And it builds a foundation for future recruiting efforts.

Outreach that fails to address fears about clinical trials.

Stories about study participants harmed during trials make the news from time to time, making many people hesitant to sign up. Your recruiting message can go a long way toward dispelling those fears by explaining in conversational language what the study is for and why it’s safe. Use media interviews, guest blogs and social channels to educate a wide variety of possible participants. Even brief ads can address common fears very easily. Early recruitment ads for HIV vaccine studies, for example, addressed a common fear upfront: “You can’t get HIV from this vaccine.”  

Not providing access to people of color and other minority groups.

People of color historically have been greatly underrepresented in clinical research trials. If you are running a clinical trial that crosses demographics, build into your recruitment model a clear plan to reach this audience. Speak to groups in the community, have your medical institution post it on its website and in waiting rooms, and set up processes for medical offices to share information with patients when possible.  

Using tools that don’t show clear recruiting metrics. 

Recruiting with a CTMS allows you to track your metrics and base decisions on what’s working and what’s not. It also helps manage and nurture subjects, allowing organizations to manage participants in one centralized location. You can also use a CTMS to create milestone enrollment goals and check enrollment progress for all studies at your site. This allows you to focus on and prioritize recruitment efforts. Tracking your recruitment efforts and outcomes can play a strategic role in deciding the best strategies for how to recruit for future studies.

Paying attention to recruitment strategies, execution, and measurement are critical components of any IIT. Not only will it allow you to fulfill patient needs, but it will help you reach your target audience and boost study enrollment.

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