Pediatric Clinical Trials Recruitment and Retention
A Management Approach to Recruitment and Retention in Pediatric Trials
Juan Castillo, MDJuan Castillo, MD, MA in BioEthics(c), CRP, PVA
Clinical Research Consultant @ CRA School
In pediatric trials, management methods and effective research tactics strengthen the recruitment and retention of subjects. These actions in combination lead to the success of a study.
Project management approach differs from research coordination practice. However, they work hand to hand to bolster the clinical trial recruitment. This paper focuses the attention on the management process of recruitment and retention in the pediatric population over the course of a clinical trial.
Research Coordination and Project Management Approach
Working with the Clinical Investigator and under his direction, a research coordinator (CRC) must handle the bulk of daily activities related to the clinical trial and plays a critical role in study conduct. The CRC has a crucial function in the efficient and effective implementation of the study and can adapt project management strategies to increase funding for trials. CRC has multiple responsibilities. They include assisting in evaluating the feasibility of new protocols, preparing the site, accruing and retaining research participants. Additionally, they must assure that each year an institutional review board approve and reapprove a clinical trial. The most important role of the CRC is to maintain the safety of subjects, to ensure that the trial is safe and conducted in compliance with the regulations.
Recruitment and Retention of Subjects
Medical research finds in the design and conduct of pediatric trials one of the biggest challenges and these studies need specialized expertise for their success. Children enrollment and retention also require taking into consideration key issues to avoid failures. The awareness and acceptance from the parents of the clinical trial demand particular attention and becomes one of the most important aspects of positive results. The outreach and engagement techniques are the cornerstones for effective recruitment and retention of research subjects in childhood. On the other hand, it is fundamental to understand and have in mind that adult and pediatric trials are different.
Project management (PM) applies to all aspects of clinical trials and ensures project organization, which keeps tasks on track and uses highly productive action items, agendas, and deadlines. To bolster the recruitment, the author shows two tactics: “The art of identifying subjects” that focuses on efficiently recognizing eligible and desirable research participants and, “a team approach.”
Successful engagement of subjects depends on a formal discussion with the family to assess the feasibility to participate in the study. Therefore, available time, interest, and commitment to enter into the trial are essential for the enrollment. With children, the relatives must clearly understand what for is the study and what to expect for taking part in it, be free to ask questions, have adequate time to think over the options and get better informed about all details in order to decide. Keeping contact and regular follow-up with the research coordinator is crucial.
A “team approach tactic” also bolsters recruitment in a study. However, it requires a plan or a method for managing the addition of more people to work in the trial. This approach becomes essential to provide formal training to the staff, and allows the members to suggest how to improve the performance.
On the other hand, poor recruitment needs an adequate response to detecting if the process goes as planned and/or why it does not have the desired results. The first effective action is to “research” what the site is doing to enroll subjects to attempt to “redefine” the recruitment performance. Conversations with investigators and staff from other studies can help to get new ideas for enlisting participants. So, “recognizing” the problems allow the CRC to determine what to modify, change or make better. In some cases, it is necessary to “relocate” to an alternative area or to a different site. As soon as recruitment improves, the research coordinator must be “ready” for work overload. However, low enrollment gives more time to prepare study documents, and issues needed for subject visits.
The Importance of Successful Recruitment and Retention
Successful recruitment and retention of the subjects turn into vital factors to (a) reach the desired sample size; (b) attain an adequate power for a valid statistical analysis; (c) produce worthwhile results; (d) meet sponsor expectations to assure further funding; (e) publish, gain recognition and renown; (f) obtain new grants for other studies; and (g) last but not least, to help patients. A satisfactory experience of the families in the pediatric studies can stimulate more families to be recruited in the future. A good reputation in recruitment and retention can secure subsequent funding. Active and strong communication between the research coordinator and the sponsor is crucial to success, no matter if recruitment is going well or not. Furthermore, in times of need, the sponsor’s help is fundamental.
Successfully Retention of Subjects
Keeping of the recruited children requires handling the subjects, the process, the study timelines and, tracking the study. Therefore, maintaining real-time recruitment logs becomes a high-priority step for optimal project management to retain participants. Tracking logs ensure that information about the responsibilities of the team is accessible to all people involved in the research.
A key point for successful retention is recognizing how the enrolled child, their relatives, the members of the staff, and Investigators are doing. It is important to become aware of what is happening in the subject’s lives and their families. Knowing whether they are enjoying or not being part of the study. It also needs to realize how the research staff and coordinators are doing and whether they can manage their work. Research teams are very busy but it is important to encourage good completion of tasks taking in mind their time and organization.
Another clue to succeed in pediatric trials is programing meetings with the sponsor to discuss the study. The PM must set up them at least quarterly. The PM must also know and recognize how and what is doing or did. Stress from the PM and staff members can emerge and subjects and families will see it. For that reason, it is necessary that the PM meets the personal, be aware of family needs, manage well study timing and requirements, and in the best way, helps the team to balance work and life outside of work. Moreover, to increase the strength of the research group, the PM must consider each day the status of the team and the study and encourages all running together.
Dealing with Poor Retention
When retention does not go well, it is important not to give up. The project manager’s attitude will affect the entire research team. Programed touch-point meetings for all the members of the staff provide ongoing guidance and support for all involved in the research. It is essential to keep contact lists for all the people associated with the project. All the time, schedules and calendars must be available to all members of the team. It is meaningful to discuss difficult issues with the families and praising and engaging research subjects.
Other tactics to success are: (a) responding quickly to obstacles; (b) avoiding procrastination which can result in a non-compliant participant or study abandon; (c) analysis of the tracker log to see tendencies of retention burdens during the year or withdraw trends to act in the root causes and respond adequately in order to maintain engagement; (d) early, creative, and respectful discussions with the research group about non-compliance; (e) improving family trust in the research team and finding the way to keep subjects and their families involved throughout the study; (f) encouraging the members of the research team and making them feel full of energy; and (g) having more time off being confident with well-trained back-ups.
Good management approach and teamwork are essential for positive results of recruitment and retention in pediatric research. Knowledge of subject’s and families’ needs and expectations helps to maintain engagement during the study. Timely meetings with the sponsor and the members of the staff are indispensable to succeed in trials in childhood.
1. Allen, Janelle R. Recruitment and Retention in Pediatric Clinical Research Trials: A Project Management Flow-Through Process. SOCRA SOURCE © August 2014.
2. ICH GCP E11 Guideline, Clinical Investigation of Medicinal Products in the Pediatric Population, CPMP/ICH/2711/99
3. ICH GCP E11 (R1): Final Concept Paper, Clinical Investigation of Medicinal Products in the Pediatric Population, dated 17 July 2014
4. Health Canada Addendum to ICH Guidance Document E11: Clinical Investigation of Medicinal Products in the Pediatric Population, Guidance for the industry, effective from 2003/12/17