Patient Recruitment for Special Populations
Patient recruitment for clinical trials is one of the most important, yet underfunded, components of a clinical trial.
Moving forward on a clinical trial without a proper recruitment strategy is a gamble that certainly is not worth the risk. That risk becomes higher when you need to recruit a special population—factors that increase risk can include prevalence, nature of the disease state, number of sites, number of countries, patient profile and patient recruitment budget. Two specific special populations that require specialized strategies are pediatric and hospital-based recruitment.
Pediatric trials represent a complex area of drug development, and conducting trials involving children presents unique challenges compared to adult studies. According to the Forum on Child and Family Statistics, although children comprise one-quarter of the U.S. population, an analysis of ClinicalTrials.gov revealed more than 10 times as many adult trials were registered compared with pediatric trials. With the under-representation of children in research, it is vital that ongoing studies meet recruitment timelines. Due to the vulnerable nature of the target subjects, pediatric trials are implemented under heightened regulatory guidelines.
Patient identification in the majority of pediatric studies is challenging, due to the availability of relatively small and finite patient populations as well as the complexities of parental involvement and family decision making. Protective parents rely on trustworthy physicians for guidance on whether or not their child should consider participating in a trial. In pediatric trials, the parent or guardian plays a crucial role in the decision to participate. This can be a difficult decision for any individual, but when that person is making the decision on behalf of a child, concerns over the potential risks of participation are multiplied significantly.
Recruiting for clinical trials that target children under age 18 requires having solutions for parents’ need for detailed information about the study; assistance with time away from work, other children and school; and reassurance from the study staff that their child is in good hands. Providing tools to support the site staff’s discussion with families, as well as the information for parents, is critical to enrollment success. Family-oriented compensation such as for childcare, transportation or meals during long visits also may affect the success of pediatric recruitment.
Managing recruitment in a hospital, Intensive Care Unit, clinic or similar setting also involves special considerations. It requires a detailed understanding of the patient flow within the particular institution. Hospital information systems (HIS) should be used to access routine patient care data to effectively identify potential trial participants. Once identified, information can be sent to study personnel quickly by email and/or text message. Many of the personnel in these settings rotate with shift changes and operate in a much different environment than a physician’s office.
It is important to identify all points of contact and ensure they all have knowledge of the study opportunity and have access to tools to make the study consenting and enrollment process as easy as possible. Utilizing tools such as educational DVDs can help explain study requirements to potential participants using a consistent message. Various other tools can be made available to site staff to maintain study awareness and allow quick access to study information. Patient consent and follow-up in hospital settings is made much more difficult by the frequent need for surrogate consent and post-discharge care by different physicians. Ensuring strong linkages exist between the investigator and post-discharge caregivers is critical. And relevant collateral for caregivers that explains the trial and the informed consent process, as well as post-discharge needs, also is critical.
It is essential to understand the importance of recruitment for any clinical trial, but when faced with the task of developing a strategy to enroll hard-to-recruit special populations, particular considerations of the population and the communication methods available must be addressed. Because pediatric and hospital-based clinical trials make up a smaller percentage of clinical research, the importance of meeting recruitment goals is heightened. Not all recruitment tactics are appropriate or will be successful, but specialized strategies can increase success.
Ashley Tointon supports innovative, data-driven techniques to provide high-impact, cost-effective recruitment and retention programs. She has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Email comments and suggestions to email@example.com
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