• by Neil Weisman , July 16, 2013

It’s no secret that, while most American adults have an appreciation and fascination for healthcare and the practice of medicine, it is often accompanied with an equal - if not greater - level of skepticism. 

Introduce those adults’ children into the equation, and the skepticism and potential barriers become even greater.

While parents are sure to have their guard up for their children when considering nearly all healthcare product and service, that guard is especially strong in the realm of patient recruitment. Research has shown that parents might accept certain research risks for themselves, but would be unwilling to accept those exact same risks on behalf of their child; consequently, parents don’t want to carry the responsibility of enrolling their child in a clinical research study should something go wrong.

Given the importance of pediatric research, and the fact that most medicines intended for children have still yet to be clinically studied in those same children, we recently conducted research and published a white paper, “Accelerating Recruitment for Pediatric Clinical Trials: Connecting Parents, Children and Investigators,” that explores the unique barriers a parent faces when considering enrolling a child in a clinical trial. Physicians with pediatric clinical trial experience were also surveyed about the challenges they experience when recruiting children for clinical trials. Here are some of the key insights.

Identifying the Target Parent

Through research, a core target demographic of parents that are more likely to enroll their child into a clinical trial was identified. The target revolves around prescription satisfaction levels and willingness to consider alternative treatment. Of the children who took prescription medication for their condition (75% of the sample), 62% of their parents were not completely satisfied with their child’s medication. 

• 85% of parents said they either were willing, or might be willing, to switch their child’s prescription medication. 

• From this group, 47% of parents were very interested in enrolling their child in a clinical trial.

Compared to the total sample, parents in this core group were more likely to be younger (age 25-44), better educated (college/post-graduate degree) and employed full-time.

Know where your message is coming from

It was important to explore the communication process between investigators and parents, given that investigators play an influencing role in the enrollment process. Research revealed a disconnect between investigators and parents, as investigators were not sufficiently addressing key parent barriers and motivators to enroll their child in a research study. 

• 74% of physicians listed altruistic benefits as a key focus point when discussing the study with parents, while only 49% of parents listed altruism as a top motivator.

• Parents wanted physicians to address how a trial would affect their child specifically.

• Parents also wanted to be assured that their child’s health would be closely monitored (57%), a concern physicians didn’t even list in their top four reasons.

Furthermore, when asked how they prefer to communicate about a trial, parents and investigators showed significant differences.

• Core parents preferred email (55%) and physical letters (32%), whereas study physicians rarely favored email (65%) and didn’t rank letters at all.

• Every study physician listed face-to-face communication as a preferred form of contact (100%), significantly greater than the 45% of core parents who indicated the same opinion.

With these statistics in mind, it was clear that investigators and site staff must clearly articulate study benefits and challenges to parents and address the parents’ key concerns. With that in mind, it’s recommended that sponsors provide investigative site coaching and collateral material to assist with delivery of these key study messages. 

Also, while face-to-face communication is effective, this younger parent demographic was accustomed to using digital communications to stay informed. Thus, sponsors should develop email templates for sites to inform parents about the study and consider using a third-party provider that would enable secure email.

By identifying the core parent and exploring the source of communication for those parents, the white paper was able to produce a number of valuable insights that should improve the process of pediatric patient recruitment for future clinical research studies.