When designing pediatric clinical drug trials, it’s important to work with the entire family to ensure the experience is convenient, comfortable, and rewarding. If certain factors are overlooked, families may drop out of a trial, making it difficult to complete a statistically relevant trial. From the recruiting process to the running of the trial, there are a few recommended procedures that can improve success rates and increase participant satisfaction.
Require permission from only one parent.
Unlike adult clinical trials, in which participants can give their own consent for treatment, pediatric clinical trials require permission from a child’s parents or guardians for a child to take part. In fact, parental informed consent is a key ethical requirement for the enrollment of pediatric clinical trials. Because parents know their children intimately and care deeply for their welfare, they can reasonably be expected to make decisions that reflect their children’s best interests. In addition, parents have the right to raise their children according to their own standards and values.
Whether a pediatric trial requires permission from one or two parents (or guardians) influences the number of eligible potential participants. In many circumstances, obtaining permission from two parents instead of one is significantly more difficult. Pharmaceutical companies and biotech companies can often greatly improve their recruitment rate by stipulating that only one parent or guardian must grant permission for the child to participate. So when federal regulations allow for it, it’s best to require the permission of only one parent.
Offer support to caregivers.
Parents have a lot on their plates already. If a pediatric clinical trial puts too much strain on parents and their families, participation in the trial will plummet. The goal should be to minimize the disruption to participating families, offering a wealth of support to caregivers. There are a few ways to accomplish this, including hiring excellent patient care coordinators, simplifying procedures, and providing a comfortable waiting space:
- Select patient care coordinators with care. Hiring friendly patient care coordinators who are skilled at communicating with both children and parents will make the experience more pleasant for participants. Patient care coordinators must be patient, welcoming, and comfortable talking with people of all ages. They should also expect parents to have more questions than the average adult participant and to expect more thorough explanations of procedures. An investment in patient care coordinators will enhance the quality of communication in your trial.
- Simplify procedures. Both during and between clinical visits, all procedures should be as easy as possible for families to follow. Explaining the process in clear, age-appropriate terms will ensure that the child understands and increase the parent’s comfort level. Avoid complicated instructions, and encourage participants to ask questions. The aim is to make participation in the trial simple and stress-free.
- Offer a comfortable waiting space. During clinical visits, families will be far more comfortable if they can relax in a dedicated waiting space. Parents can use the space for playtime, snacks, entertainment, work, and more. Not only will this increase families’ comfort levels in a clinical environment, but also it will allow them to maximize their time during the clinical trial and reduce the inconvenience of in-office treatments. This, in turn, will reduce the number of drop-outs and increase completion rates.
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Pediatric clinical drug trials are critical to the development of safe and effective treatments for children. Using the tips above can simplify and accelerate the process, increasing the odds of success and reducing the risk of a statistically irrelevant trial.
Since 1995, QPS has provided discovery, preclinical, and clinical drug development services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email info@qps.com.
