While successfully managing any type of clinical trial involves navigating several distinct challenges, pediatric trials can bring on their own set of challenges. The additional management of family logistics and continuous support to pediatric study participants increases the risks of successful outcomes in pediatric trials.
Fortunately, there are ways to mitigate these barriers and successfully manage pediatric trials. The Vial team specializes in dermatology and has extensive experience in managing pediatric trials since many dermatology indications affect the pediatric patient population. Below, the Vial CRO team have compiled a list of best practices for running pediatric trials.
When providing dermatology CRO services, we follow a proven set of best practices in order to help our clients successfully manage their clinical trials. This includes effective guidelines for running pediatric trials, which are outlined below.
Provide Educational Materials
Providing materials to the parents, caregivers and patients that describe the study requirements, the medication being tested and the benefits and risks of participating in the study in language they can understand is key. It helps explain why the study could be valuable for them and help their disease. Providing these educational materials early in the discussions can help alleviate any questions and hesitations regarding participation. It can also help build trust and an overall comfort level for the patients and their families.
Also, keep in mind the various age groups required in pediatric trials and the developmental differences within the age groups. Developing different educational materials that are geared toward specific age groups is important for keeping potential patients informed and engaged.
Developing a positive, friendly relationship between the investigator, site staff and the potential patients and their families is crucial. Study participants and their families will feel much more comfortable attending study visits and will even look forward to attending their visits when they are familiar with the office and staff. Study participants should get to know the site staff on a first name basis. Site staff should make an effort to learn more about the study participant and their families. What are there interests? Does the family have a specific schedule the site needs to account for? Is there anything the site can do to make the study participant and their families feel more at ease during the study visits? In addition, sites should make all effort to keep the staff members consistent during the study participants time in the trial. This will create a familiar trusting environment which helps to increase study participant compliance as well as lower drop out rates.
Provide Adequate Support for Families
While the children are the study participants involved in the trial, the parents and caregivers are also taking on added responsibilities, as they must arrange transportation to and from appointments, rearrange their own schedules, and disrupt their normal routines.
In order to keep parents and caregivers on board for the entirety of the study, researchers should provide them with adequate support during the trial. This includes providing them with a comfortable waiting room and access to a reliable internet connection. Consideration should also be given to siblings of the study participants. Sometimes the study visits can be lengthy and last for a considerable amount of time. Researchers should consider having toys such as puzzles and coloring books for siblings to occupy themselves as they wait. A comfortable, child friendly environment with drinks and/or snacks can also help keep siblings as well as parents and caregivers occupied.
Allocate Additional Funding for Recruitment and Retention
Recruiting pediatric patients is much more challenging than drawing the interest of adult participants. As such, researchers must allocate additional funding for recruitment including the educational materials we mentioned previously. Additional costs for items, drinks and snacks to help occupy the parents, caregivers and/or siblings should be considered in the budget as well. Creative resources should be included to ensure the comfort level and retention of the study participants and that their families throughout the duration of the trial.
Using the strategies outlined above, your team can more effectively plan and manage pediatric clinical trials.
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About Vial: Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.