How to improve pediatric recruiting and retention
Successful programs share best practices
The University of Louisville (KY), is a new participant in the Pediatric Pharmacology Research Units (PPRU) network, but the site has history of success in recruiting and retaining pediatric clinical trial participants.
"In the majority of our studies, 90% to 95% of subjects who are approached and pass criteria join the study, and we have a 95 percentile retention," reports Janice E. Sullivan, MD, associate professor in the department of pediatrics.
Sullivan and other researchers at PPRU sites provide these tips for improving recruitment and retention of children in clinical trials:
• Create infrastructure suitable for children: "In some other places, they’re trying to do pediatric research in an adult setting," Sullivan says.
At the Louisville PPRU, there are televisions in rooms where children wait, along with a play room with games and age-appropriate toys for young children to teens, she reports.
"When they’re not giving a sample or doing other research things they can play in the research unit," Sullivan says. The children participants are given food or gift certificates for food as well.
The PPRU at Children’s Mercy Hospitals and Clinics in Kansas City, MO, has a playroom outfitted for all ages of children, says Gregory L. Kearns, PharmD, PHD, a Marion Merrell Dow/ Missouri Chair in Pediatric Pharmacology and chief of the Division of Pediatric Pharmacology and Medical Toxicology.
The research unit looks no different from the patient care unit, and the facility employs play therapists, who are similar to pediatric occupational therapists, and who interact with the children, helping them with crafts and other activities, during the long hours in which the children are waiting between research interventions, he says.
Since the children might spend 12 hours at the site and interact with research staff for about 1½ hours of that time, the play therapists play an important role in helping to recreate normal activities during the day, Kearns adds.
• Make appointments convenient for families: "Families like it if they can come in as part of the study and get the dental appointment done at the same time," he says.
"We try to integrate the research into the whole context of care, and part of that is educational too," Kearns says. "The reason we do clinical studies of new drugs is to improve therapy."
The University of Louisville site also coincides study visits with participant’s regular clinic visits, says Mary Jayne Kennedy, PharmD, assistant professor in the department of pediatrics and a co-principal investigator on PPRU.
"If patients are following up in the clinic, we’ll do a follow-up for the study over here, so it’s convenient for parents and their schedules," she says.
Also, parents of teenagers have the option of leaving the children at the clinic to return to work if needed. The research staff will call them when they’re needed, Sullivan notes.
"We try to work with the family and because of school schedules, we do see some patients on the weekend if we need to," she explains.
• Staff develop rapport with children participants: "They spend a lot of time up front going through the consent forms and making sure the families have a good understanding of the study and what their responsibilities are throughout the study, and we build on that at each return visit," Sullivan says.
Study coordinators call patients to see how they’re doing and to remind them of their study visits, she says.
To provide study coordinators with the time they need to develop this rapport, the Louisville PPRU has a unique staffing structure, Kennedy notes.
"All our coordinators do is interact with patients and do nursing activities," she explains.
Regulatory coordinators handle IRB paperwork, adverse event reporting, financial disclosure forms, and other research documentation, Kennedy says.
"Regulatory coordinators keep everyone informed of any changes in the regulatory arena and maintain regulatory binders," she adds.
• Enhance informed consent experience: "The parents of a child in a study are as much of a participant as that child," Kearns says. "So we want the parents to understand the reasons why a study is being done, and we want them to put a value on the potential contribution the study data will produce."
So study coordinators spend longer on education for a pediatric trial than they would for an adult clinical trial, he says.
"On average it takes our folks about an hour to do an informed consent," Kearns says. "And even before the consent form is produced our study nurses and investigators will spend time talking to the parents about the problem for which the study drug is intended."
The University of Louisville (KY), is a new participant in the Pediatric Pharmacology Research Units (PPRU) network, but the site has history of success in recruiting and retaining pediatric clinical trial participants.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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