Most Parents are Open to Pediatric Clinical Trials: You Just Have to Ask
By: Cynthia Jackson, DO | January 20, 2015
Although there is no question that pediatric clinical trials are essential to demonstrating the safety and efficacy of treatments for children, conducting these can be frustratingly difficult. They are especially challenging to recruit for, in part because researchers have had little insight into what motivates parents to enroll their children in trials – until now.
At the recent American Academy of Pediatrics National Conference, we presented the results of a survey of US parents and caregivers to understand what influences their willingness to enroll their children in clinical trials. The results suggest that our assumptions may need to change: 73% of parents say they are interested in having their child participate in an appropriate clinical trial – yet 96% of them say they have never actually participated in a trial. Why? Primarily because they have never been asked.
Until this survey, we knew little about the factors that influence a parent’s decision to permit their child to participate in a pediatric study, and the industry has struggled to figure out how to reach these parents and encourage them to participate in potentially life-prolonging research. But now we have answers that can help us inform the pediatric clinical trial planning process.
What we learned
The majority of parents and caregivers would consider allowing their child to participate in a clinical trial, particularly if their child had a medical condition that they considered to be serious.
The most common reason for not having their child participate in a trial is that they have never been asked (73%). This should be viewed as an opportunity for the clinical trial community. If they develop better communication channels with parents, they can overcome the biggest obstacles to trial participation.
The factors that most influenced their decision included their child’s health, potential adverse events of the study medication, and the ability to improve the lives of other children. These issues should be addressed up-front when talking to parents about the value of joining a clinical trial.
Their most preferred method to learn about a trial is at the doctor’s office or through friends and family. Their least preferred method is through advertisements and social media. This underscores the importance of trust in the trial education process. Parents are more open to these opportunities if they learn about them from people whose opinions they value.
What to do next
These data offer the biopharma industry a roadmap for improving the way it plans and recruits for pediatric clinical trials. Most importantly, it shows the need for better communication with parents and pediatricians. The data show that once this population is approached about a trial, the vast majority will agree to participate. The challenge is finding the best ways to connect with them.
To open these lines of communication, researchers must first understand the patients’ pathway: How and where families and children enter the healthcare system and where they will end with a particular diagnosis. From there we can determine strategies for interacting with the primary treating physician and where a researcher may become involved. Parents tell us information is best received from their healthcare provider whom they trust. This journey will tell them when and where to engage the patients and their parents at the ideal point in their treatment experience.
They also need to find ways to encourage physicians to make clinical trials part of the treatment conversation. Pediatricians have precious little time to spend with their patients, so even if they are aware of trial opportunities they may not prioritize talking about them with parents when there are so many other things to discuss. This is a big obstacle for trial leaders to overcome, but it can be done.
Pediatricians and other primary health care providers are the most valued source of information for parents, so researchers need to engage with them early in the trial process, to share the benefit of encouraging trial participation, and to help them develop new lines of communication with parents outside of the office visit. This may include inviting them to host or participate in online patient communities, providing them with trial information that they can share virtually with parents, and encouraging them to discuss trial opportunities in follow-up emails with parents, which can be viewed as a value-add to the office visit.
At the same time, biopharma companies should develop their own communication efforts to educate parents about the safety and value of participating in pediatric clinical trials, to show them where they can learn more about trial opportunities, such as www.clinicalresearch.com, and encourage them to ask their pediatricians about appropriate opportunities in their area.
Why it adds value
These communication initiatives can reduce the time it takes to recruit patients for pediatric clinical trials, which directly correlates to reduced cost and faster time-to-market. But biopharma companies must factor these efforts into the preplanning process for pediatric clinical trials, ensuring they are part of the project schedule and budget. Patient recruitment and retention is imperative to the success of these efforts, and spending a little extra time and money up-front to engage this hard to reach population will deliver long-term strategic benefits down the line.
More importantly, however, we must not forget that pediatric trials provide meaningful information about medications used to treat illnesses in this important age group. As such, it’s imperative that these studies are not only conducted, but done so efficiently and compassionately with the end user – children – in mind.