The groundbreaking mRNA technology used in the COVID-19 vaccine has potential applications in preventing a number of other infectious diseases and is ushering in a wave of new vaccine development. At the time of writing, there are over 1,700 active vaccine trials found on clinicaltrials.gov. In our own practice at Accellacare, we’ve experienced a sharp increase in the number of vaccine trials we’re supporting; we estimate that we’re recruiting for 30 percent more trials today than in the pre-COVID era. Covid-19 also highlighted the need to increase diversity in clinical trials for equity and also to ensure that the vaccines have been tested in appropriate subgroups. This has heightened the need for finely tuned-recruitment strategies. At the same time, the public’s experience with COVID-19 vaccines has led to a degree of “vaccine fatigue and hesitancy” that makes recruitment for vaccine trials challenging, over and above the growing competition for participants. There are, however, a number of strategies and tactics that have proven successful in reaching potential participants, educating them on the value of vaccine research, and motivating them to take part.
Numerous Factors at Play
Enrolling participants in clinical trials for vaccines is challenging for several reasons. First, there’s simply a greater demand for the eligible pool of participants, and enrolment periods are typically short. Not only are there more studies, but studies are also larger; it is not uncommon to seek 20,000 to 25,000 participants per trial. Plus, participants should represent the target population in all of its diversity. The US Food and Drug Administration (FDA) encourages drug sponsors to ensure that “people of different ages, races, ethnic groups, and genders are included in clinical trials.”1 Second, factions of the public have questions about the new technology used in the COVID-19 vaccines and the apparent speed with which they were developed. The political climate – coupled with misinformation and disinformation about the virus, treatments, and vaccines – has fuelled vaccine hesitancy and polarised people. And a pre-existing mistrust of the medical community in some demographic groups has made matters worse. Third, the public has been exposed to a glut of vaccine-related news for nearly three years. A Google search for “vaccines” netted 3.5 trillion results. Yet, ironically, it seems that the public is largely unaware of the risks posed by the many other non-COVID diseases (such as a respiratory syncytial virus (RSV)) on which vaccine research is being conducted.
The traditional methods of recruiting participants – connecting with investigators and employing digital media to reach potentially interested/eligible people – are no longer sufficient. These pre-pandemic tactics must be augmented with initiatives at the community, site and individual participant levels.
Build Relationships within the Community
If we are to overcome vaccine hesitancy, the public must come to trust the research community and understand the research process. Long before the start of any study, sites and site networks need to be engaged within their communities to develop relationships and demonstrate being trusted partners who will be around for the long haul. Sites can, for example, offer value to the community by holding general health screenings, mental state exams, blood pressure or diabetes screenings, and increasing access to healthcare. Sponsoring community organisations and events at the senior center, children’s sporting events, and church activities are all ways of connecting with potential participants. Accellacare has pursued this approach with success. To mark the grand opening of a treatment center on a busy urban street, we sponsored a food truck over the lunch hour and gave tours of the clinic. Over 200 people attended, with 140 opting into a database of interest in clinical trials. The cost of acquisition per name was calculated at just $40 – far less than the cost associated with digital advertising campaigns and enabling us to have a more targeted approach to recruitment.