Senior citizens tend to have less-than-optimal vaccination rates – even for proven vaccines that bring significant health benefits. Unsurprisingly, then, they are hesitant to engage in vaccine-related clinical trials to test new medications. The way to remove this hesitancy is to engage senior citizens by building a circle of trust: a circle that has as its center the education of both the site staff and potential patients.
The circle begins with the recruiter. It is imperative that the recruiter possess an understanding of the disease being addressed by the clinical trial. The reason is this: if the recruiter is unable to verbalize at least basic information about the disease, the call will typically end with the senior citizen declining to participate. Being able to explain the disease at a basic level helps the potential patient understand the need for a working vaccine. In contrast, the recruiter does not need to have any specific knowledge of the vaccine itself.
For example, a recruiter might say the following about clostridium difficile (C. diff.):
"Clostridium difficile is a bacterium that can cause a severe form of diarrhea. The Centers for Disease Control, a U.S. government agency that monitors the health of America, estimates that there are almost 500,000 cases of C. diff. per year, leading to approximately 29,000 American deaths every year. That is about the same as the number of people killed in auto accidents in the United States each year. C. diff. is a significant health problem. This clinical trial involves a vaccine for C. diff. We don't know yet if the vaccine will prove to be effective – that is the reason for the clinical trial: to see if the vaccine works."
It's not a huge volume of information, nor is it technical information. But it provides everything the senior citizen is likely to want to know at this juncture.
The circle of trust continues at the screening visit. At the screening visit, the senior citizen is informed of the risks of the trial as part of the Informed Consent process. All questions should be thoroughly answered at this time – even if you have to schedule a second visit to do so because the patient has a lot they want to discuss. Taking the time to answer all questions and concerns is vital to patient engagement, and builds a firm foundation for patient retention over the course of the trial.
The circle of trust extends to include every staff member. Patients interact with many members of the site staff during the course of a clinical trial. All staff members should have basic training on the disease process and the study protocol so that they can personally engage with patients at any time who may have questions. Knowing that the site staff is well educated is reassuring for patients who may be nervous about the clinical trial.
One of the best methods of creating this circle of trust is to develop educational materials that the recruiter, site staff, and patients can all read and reference. The materials should be clearly written in a reader-friendly style, and zero in on the information that is most important to patients (rather than on technical details that patients would not typically be concerned about). Something as straightforward as a well-thought-out brochure can serve as the lynchpin for the circle of trust.
Vaccines are an integral part of our medical arsenal, so it is imperative that sites become experts at recruiting and randomizing patients from the senior citizen population. Just remember: success begins with trust.
Want to learn more about Bioclinica's capabilities and experience in vaccine development? Download our data sheet.