Pediatric Patient Retention: It’s not Child’s Play Elizabeth Moench President and CEO Samantha Cook Pediatric Account Manager John Hartigan VP, Creative and Editorial Services The Ever-Changing Population A universal challenge of conducting long-term pediatric studies is the constant growth and development of the young patient; an issue not encountered with retention programs designed for adult populations. Materials developed to support the participation of children in clinical research must be designed with a keen awareness for the rate of continuous developmental change. Depending on the length of the study, multi-year pediatric protocols may require the recruitment and retention of children ranging in age from 2 to 17 years. The cognitive and physical stages of development represented by this group span from the point a child begins to talk through adolescence and into adulthood. Retention materials must follow the child through study participation and be targeted according to development. Retention programs for pediatric studies should address the dynamic nature of this population, following a child over the course of study participation. The result is higher development costs compared with similar programs designed for adults. Furthermore, the design of such programs warrants the inclusion of a multispecialty team, including child psychologists, educators, parents, children, and healthcare professionals. All multi-year clinical studies involving pediatric and adult populations require a strong retention strategy. For adults, the retention challenges are generally situational rather than developmental as seen in pediatric populations. For instance, situational factors for adults in their 30s and 40s that affect study participation are related to family and work. For the elderly, the situational issues may relate to transportation logistics and familiarity with the study site’s location. The Mom Factor As research participants, children are more vulnerable than adults. Parents, guardians, and other caregivers are extremely protective of their child’s well-being and rights when participating in clinical research. For this reason, the retention of children in clinical studies requires the retention of the parents, particularly the mother; this adds yet another layer of complexity to an already challenging pediatric recruitment and retention process. Retention of participants can be problematic when clinical trials stretch over weeks, months, and even years. Keeping children in a research study until its completion requires the active engagement of their mothers. In fact, compliance and data quality are dependent upon mothers playing an active role in research activities, particularly in keeping their children adherent to the study protocol. They supervise their children’s study-related tasks on a daily basis to ensure requirements are met. Many mothers report that their spouses’ work schedules often limit their ability to accompany children to study visits. Transportation to and study attendance at appointments falls to the responsibility of the mother. When the chronic illness of a child intimately affects the everyday life of the entire family, it is important to identify factors that encourage mothers to keep their children involved in a clinical-research study. The mother is often the person most affected by the diagnosis of chronic illness in a child, and she tends to take on the major responsibilities and demands of the treatment regimen, such as organizing meals, monitoring symptoms, and arranging healthcare and study visits. In addition to the logistical demands of caring for an ill child, there is also support that must be provided to a child or adolescent striving to develop a sense of autonomy in the face of his or her medical condition. The integral involvement of the mother in the daily management of her child’s physical and emotional health illustrates the significance of gaining an understanding of this caregiver’s perspective and decision-making processes. Key motivators should be identified and considered before the development of a recruitment or retention program targeting this population. Assessing the Research Opportunity Clinical research can be intimidating for adults. Imagine the depth of the decision a parent makes when choosing to enroll his or her child in a clinical study. First, is the careful consideration of the potential consequences for the child. A parent will always consider risks before benefits. Next is an understanding of whether the study will disrupt the child’s well-being. For example, a parent needs to understand the careful monitoring involved in a “washout” period. Another factor for consideration is the possible disruption to the family; disrupted meal times, changes to siblings’ schedules, etc. While the risk factors are often weighed first, parents want to understand the potential benefits of participation in clinical research, including an assessment of “what’s in it for my child to participate?” A consideration of benefits involves a balancing of the opportunities afforded by research participation against the risks and burden of study tests and procedures that might be incurred. In general, a mother wants to know that her child has a sufficient understanding of the clinical study, and that the child agrees to be in the study before a final decision about enrollment is made. Some mothers will calculate risk for their children based on the knowledge that the new treatment or technology had been successfully tested in adults or is the standard of care for children in European countries. While these type of data are reassuring, the decision to participate can be based on less concrete evidence, assuming that clinical trials would not be open to children unless safety and efficacy tests had been conducted successfully in adults. A mother’s decision to enroll her child in clinical research comes with the expectation that there may be a direct and immediate advantage for the child. Daily illness-related behaviors will be made easier, more convenient, or less painful, such as an oral medication versus an injectable, or reduction in daily dosing. While these factors take precedence and monetary remuneration is not necessary for retention, most mothers recognize that an incentive is important for maintaining the the child’s or adolescent’s interest in clinical research. Positive Interaction with Study Staff Mothers expect study nurses and physicians to be knowledgeable, approachable, personable, and trustworthy. Well-designed recruitment and retention tools that describe the study in a way that children can understand help to establish the foundation of a trusting relationship. Some children are intrigued with research participation after the doctor or study nurse clearly explains the process while treating them with respect. Positive interactions with study staff leave a lasting impression and help to instill trust in both the child and parent to encourage compliance. A mother’s observation of a study coordinator interacting with her child in a responsive, caring, and patient manner is invaluable for retention. Other factors that can influence patient retention include flexible scheduling of study visits to adjust to a mother’s hectic schedule, as well as staff turnover, specifically changes in coordinator assignments, which can disrupt the continuity of care and trust for both the mother and child. Personal Touches … Personal Benefits Without exception, mothers expect that their children will personally benefit from participation in a clinical-research study. Just as a mother desires involvement with the family pediatrician, she expects to see the study doctor at every visit. The reality of clinical research dictates that a single physician at a busy research center will not be able to spend time with the parent at every visit. A deficit in this personal attention communicates a lack of concern and credibility. Pediatric-retention programs, tailored by age and designed to engage the child in activities during study visits, can help to bridge this gap of a noninvolved doctor making study visits easier for children and mothers alike. These types of programs provide an added personal touch to study participation and tell mothers that their child is of special importance. Furthermore, changes in a child’s self-perception or attitude toward his or her medical condition can also be a personal benefit of study participation. Study participation can build up a child’s self esteem, especially when a personal touch, such as a certificate of achievement signed by the study doctor, is presented to the child at the study’s conclusion to say thank you for contributing. Plus, it has the added benefit of communicating to children, specifically those with a chronic condition, that they have been an active partner in improving the quality of their own life. As research participants, children are more vulnerable than adults with regard to cognitive and emotional development, level of autonomy, and dependence on family influence. Regardless of whether the study participant is an adult or a child, successful clinical studies still require a personal touch supported by a well-thought out patient-retention program. June 2007 VIEW on Clinical Services MediciGroup Inc., King of Prussia, Pa., delivers global patient recruitment and patient retention strategies for clinical study success. For more information, visit medicigroup.com. With U.S. federal guidelines now mandating the inclusion of children into clinical trials (National Institutes of Health, 1998), biopharmaceutical companies are increasing the number of pediatric clinical studies. With the inclusion of children in clinical research comes mounting complexities. Pediatric clinical trials involve a unique set of challenges that can result in increased costs for patient retention, as well as additional time required to develop customized retention programs.

Download PDF