Pediatric clinical trials are essential for developing new and innovative treatments for children. However, they can be more challenging to conduct compared to standard trials as they require more oversight. There are a few key things to keep in mind when planning and conducting a pediatric trial to guarantee a positive trial experience. This blog post will outline five tips for a successful pediatric trial.
What Makes Pediatric Trials More Complex?
Pediatric trials are more complex than adult trials for a variety of reasons.
Smaller Patient Pool
Children make up only 22% of the US population, and they generally have less severe illnesses. These considerations reduce the number of available participants in a pediatric study.
Data Collection in Pediatric Trials
Compared to trials with adult participants, who may only collect data by having the participant complete it, pediatric patients may not be able to complete the questionnaires or submit the data. This can easily lead to the data being captured in different ways, sometimes by different parents, a guardian, or healthcare professional.
Collecting Informed Consent from Children
Collecting informed consent for children can be more difficult, as children are not old enough to legally consent to a study. They might be able to provide consent through assent, but a parent’s consent is almost always necessary and appropriate. Acquiring these different types of consent will take time, as well as caring, compassionate conversations with both the patients and their parents.
5 Tips for A Successful Pediatric Trial
Allocate Enough Budget for Patient Recruitment & Trial Technology Support
Due to the complexities of a pediatric trial, it’s crucial to allocate enough funds to cover both patient recruitment and the technology that will be used to support the trial. Not only is the population of potential patients for pediatric trials smaller, but there can also be higher dropout rates as parents or patients find the study too demanding. It may be necessary to begin with a larger pool at the beginning of the study, which may require more investment than a standard trial recruitment effort.
You also want an appropriate budget for your trial technology support. Issues arising from technology that is either unknown to participants, or error-prone, can lead to delays and frustration in both participants and their parents - and these issues can easily lead to patients dropping out of the study. It’s important to invest accordingly in technology support to decrease the likelihood of dropouts.
Centralize Your Data Collection
As we mentioned above, the data collection in a pediatric study will likely be more diverse than in an adult study. Therefore, it’s important to collect and centralize the data gathered from various sources so that it can be analyzed effectively with the results from the rest of the study. Failure to do so could result in inaccurate results and conclusions from the study.
Utilize Child-friendly Protocols.
As all of the participants in the study will be children, it’s imperative to have protocols that are best suited for them. These can manifest in different ways but could be as simple as having sessions that are no more than a couple hours long, or having breaks during the sessions. Along with the other tips listed above, these types of child friendly protocols will help decrease dropout rates.
Work With Caregivers and Parents to Eliminate Friction Points.
Raising children is already a difficult and stressful activity for most caregivers. And if a study adds additional stress to a family’s life, it can increase the likelihood that a patient will not complete the study.
To help reduce stress, it’s imperative that there are open lines of communication between trial staff and caregivers/parents. Do your best to identify and eliminate potential friction points before they become a problem for your study.
Be Aware of Your Timeline - Eliminate Unnecessary Meetings and Ensure Asynchronous Alignment to Avoid Costly Delays.
Timelines are implemented to help ensure the successful completion of your study. Adhering to them will increase the probability that your study comes in at or under budget. And revenue considerations aside, failure to complete your study on time could delay getting the medicine to those who need it the most.
It’s important to streamline your communications to avoid unnecessary meetings to prevent these delays. By leveraging asynchronous alignment, you can be sure that everyone’s time is utilized effectively and efficiently - keeping your study on budget and on track.
One note of caution, while there are plenty of asynchronous tools on the market (email, messaging, document management apps, etc.), many lack the security, integration, and compliance-required tracking/reporting capabilities needed to meet the requirements of the clinical study. To ensure compliance, it’s important to select an asynchronous toolset that meets the traceability, auditability, and reportability required of a successful pediatric trial.
Pro-Tip: Our asynchronous communication tools are a key feature of the Cloud Concinnity Platform. Through Cloud Concinnity, your team can comment and respond to critical questions, data notes, and action items in a secure, cloud-based environment – eliminating redundancies and helping to streamline communications. Learn more and schedule your Cloud Concinnity demo today.
By following these tips, you can increase the chances of a successful pediatric clinical trial. If you have any questions or concerns, please contact us. We are here to help. We are happy to give you a free demo of our cloud-based software that promotes collaborative communication, easy-to-follow processes, and transparent outcomes that help you complete your pediatric trial.