Applied Clinical Trials
Despite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging.
Despite the growing need for pediatric-approved medications, clinical trial enrollment for pediatrics remains challenging. Unlike adult clinical trials, the decision to enroll in a pediatric trial introduces a new series of logistical and emotional complexities for parents, physicians, and the child.
In a white paper completed by Blue Chip Patient Recruitment, "Accelerating Recruitment for Pediatric Clinical Trials: Connecting Parents, Children, and Investigators" (www.bcpatientrecruitment.com/whitepaper), primary market research explores the motivations and barriers a parent faces when considering clinical trial opportunities for their child, as well as the challenges physicians experience when recruiting children for clinical trials.
Understanding the true motivations and worries behind a parent's decision to enroll their child in a clinical trial is essential for successful enrollment. Since many medications have never been studied in children, sponsors and investigators need this type of research to successfully address the changing pediatric healthcare environment.
In looking at which parents were most interested in enrolling their child in a clinical trial, they tend to be younger (25-44), well-educated (college/post-graduate degree), and employed full-time. The incorporation of such demographic insights into parent-facing communication is fundamental to more effective patient enrollment strategies. Physicians need to tailor their communications to this highly-engaged, educated, and active parent.
Many parents state the efficacy and their satisfaction level of their child's current medication as a major motivator in potential clinical trial opportunities. Nearly 85% of the parents who were "very or somewhat satisfied" with their child's current medication indicated they would be willing to switch their child to a new medication option. One parent stated, "It [the medication] could always be better." This means that even though parents may be very or somewhat satisfied with their child's current medication, they're always looking for something better that could help their child more.
When educating parents on clinical trial opportunities, communications are led by physicians and tend to consequently focus on topics they believe are most critical. Specifically, nearly three-fourths (74%) of physicians point to altruistic benefits as a key motivator in conducting these studies. However, when we asked parents the same question the story changed. Only 49% of parents listed altruism as a top motivator. Instead, parents are concerned about how a trial will affect their child specifically; 57% of parents wanted to be assured that their child's health will be closely monitored—a concern that physicians did not even list among their top four motivations. Physicians affiliated with academic institutions cited different impressions of parental motivations than physicians conducting a study through a private practice. Four out of five (82%) private practice physicians believed a major motivation for parents is the access to free medical care. Academic investigators cited altruistic motivations as a likely incentive for involvement (60%), whereas private practice physicians suspected this was not the case (9%).
To overcome this inconsistency between physicians—and thus address parents from a more effective, consistent platform—sponsors should consider developing two sets of communications. These separate approaches may allow physicians to communicate to parents in ways that address the concerns and motivations of physician and participant, while still establishing consistency.
In the study, every study physician preferred face-to-face communication (100%) and while the parents agreed that face-to-face communication was a preferred method of communication, they were also open to other forms of communication. Written communications were favored by parents, specifically e-mail (55%) and physical letters (32%) whereas only 6% of study physicians favored e-mail and 0% letters, respectively.
Accommodating the communication preferences of parents may facilitate the removal of structural communication barriers to potential enrollment.
To adequately address the growing prevalence of R&D needs for pediatric patients, coordinators of pediatric clinical trials must seriously reconsider approaches to organizing studies. Given the wide range of complexities involved in coordinating pediatric clinical studies, it is essential that insights into the perceptions of parents and physicians be acquired and considered in study designs, so as to more effectively enroll pediatric patients.
—Neil Weisman, EVP/General Manager, Blue Chip Patient Recruitment