Consider the Five ‘W’s to Understand Potential Participants
Recruitment and retention plans will always be molded by the specific trial and population involved; putting careful thought into who your trial’s target participant is can help bolster enrollment/retention numbers, an expert advises.
Kicking off WCG Clinical’s new patient centricity webinar series, The Participant Playbook, Tyler Bye, director of program strategy and product development at WCG Study Acceleration, offered key insights for successfully incorporating patient-centric approaches into enrollment, recruitment and retention efforts.
Building a Participant Profile
One of the first steps to take when developing and considering new recruitment strategies and initiatives is to craft a profile of the participant the trial seeks to enroll, says Bye.
Doing this may take some deep thinking, but the concept itself is relatively simple: use the five Ws (who, what, when, where and why) to lay out the key characteristics of your trial’s intended population.
Start with the “who.” It isn’t always just the patient; consider that some indications will have caregivers, spouses and/or family members lending a hand with someone’s participation. This will be the case in pediatric trials or trials for a disabling disease, for instance, and would likely apply to trials enrolling teenagers as well.
In addition, think about how participating will impact a patient’s life outside of the trial. Does the trial require long visits, multiple visits or overnight stays, for example? What obligations will the patients likely have outside of the trial, such as taking care of children or pets? Think hard about how participating in the trial could interfere with or affect participants’ lives, Bye advises.
Next, think about the “where.” Where does the patient need to go to participate in the trial? A number of things are worth considering here. Is the study site convenient for them (assuming they will have to travel there for on-site visits)? Remember that for some institutions, such as larger academic medical centers, patients often take hours-long trips to get to them due to their level of care and ability.
“Is a [travel time] of two hours practical for a long-term, once or twice a week visit?” he asked.
Another factor in the “where” category is a patient’s place in the healthcare system. It’s important to consider whether they’re likely to be part of the site’s healthcare system already and whether they’re in or out of network, Bye says, noting that there will frequently be standard of care procedures beyond clinical research procedures billed back to insurance. Consider how this might affect individuals and make sure this is made clear to them when they’re being presented with a trial opportunity.
Moving on to the “when,” Bye advises considering the trial duration/timeline and when, seasonally, it will be conducted. Seasonality could play a big part in recruitment efforts, he says. For example, certain times of year will be more effective for recruiting patients with asthma and allergies than others.
“There are definitely certain times of the year where recruiting for a study like that makes a lot more sense, where someone is going to be much more in tune with their condition, understanding that their symptoms are there, where they are going to be looking for some other type of option,” he said.
Perhaps most importantly, he says, consider the “why” and “what” when crafting enrollment strategies. Why should patients take part? What are the risks and benefits of participation and the impact on their lives?
For example, it’s important to consider if participation will ultimately be altruistic, where it is unlikely to benefit the patient personally but will help other generations, or if it could result in treatment the patient wouldn’t get anywhere else.
Conversely, it’s also important to go into what it will mean to the patient who decides against enrolling. The trial could be a one-time deal that won’t be available to them again, for instance, or they might not be able to receive healthcare at that site if they decline. It’s critical to bring up these discussions with potential participants.
“These types of things are definitely conversations that will be had at the site … and these conversations will be different based on every single subject and study out there,” he said. “I know a lot of this goes into the undertones of what’s being done on a day-to-day basis, but I don’t think we oftentimes think about it in these more granular levels.”
Access The Participant Playbook webinar series here: https://bit.ly/3FjiwxK.