Even though there is a growing interest in and commitment to conducting pediatric clinical trials, about one in every five fall short due to ineffective study design, poor experiment planning, or insufficient participant enrollment.
Nowadays, more pediatric clinical trials are being conducted than ever before. The effects of medicine on children have been studied in more than 436 trials since the FDA Safety, and Innovation Act (FDASIA) was introduced in 2012. This time has come for these trials.
Many medications that have been approved for adult use and are known to be effective in treating children have never undergone testing to be approved for pediatric use. Clinical trials for children have unique difficulties that don’t apply to trials for adults.
Here are five methods to increase the success of pediatric trials
The budget Should Be Set Aside For Trial Advertising And Patient Recruitment.
It can be challenging to recruit enough participants to make a pediatric trial statistically significant. Parents are reluctant to do so because they are concerned about putting their children through experimental procedures that might have a different effect.
Pediatric populations not only have a more challenging time finding patients for clinical trials than adult populations but also have a higher risk of trial participants leaving early. When conducting pediatric clinical trials, starting with a larger than the required pool of participants is necessary because some patients or families will find trial participation too demanding and ultimately decide not to continue treatments throughout their trial.
Marketing and advertising can support the need to recruit a sufficient number of participants by drawing attention to trials. A budget is needed for media buying and creating advertisements for radio, print, television, and social media.
Additionally, it costs money to employ recruiters to speak with the families who respond to advertisements, respond to their inquiries, and sign up trial participants. Finding and securing a sufficient number of trial participants becomes more challenging when inadequate funding is set aside for recruiting and advertising.
However, pharmaceutical and biotech firms are more likely to complete a statistically relevant trial when they allocate funds for marketing trials to the parents and carers of pediatric participants.
Establish Reasonable Timelines For Paediatric Trials
Drug trials are more successful when they are timed correctly. Participants in a trial must be available for all scheduled clinical visits and treatments. When designing trials, several timing considerations for pediatric populations are typically not concerns for adult trials. School schedules are one illustration.
Children cannot frequently miss class to take part in trials. Children need to decide what hours school is in session, unlike adults, who may have some flexibility in their work schedules. It is crucial to keep this in mind when designing trials. Trials have higher success rates when conducted during breaks from school, such as summer, spring break, or holidays.
A trial’s success may also be boosted by scheduling clinical treatments for trial participants after school. The availability of pediatric trial participants and parents’ willingness to comply with trial requirements can be impacted by additional variables like parents’ employment and siblings’ schedules. Pediatric trials should always be planned with these considerations in mind.
Setting realistic timelines involves many factors, including taking daily schedules and routines into account. Trial dropouts can be avoided, and trial completion rates can be increased by keeping the length of pediatric trials to a minimum. Children and their families might be unable to endure protracted trials.
It’s best to keep trials to up to four or five months. Additionally, pediatric patients might be less tolerant of complex procedures over protracted treatment periods, such as an entire day. Therefore, it is advised to limit clinical visits for children to no more than a few hours rather than requiring full-day treatment sessions, which are more frequently needed in adult trials.
Need Parental Permission To Participate
The requirement for parental consent to participate distinguishes between trials for adults and children. Adults can give their support to be treated, but parental or guardian approval is required for children to participate in trials.
The number of eligible potential participants will vary depending on whether a pediatric trial needs consent from one or both parents. Getting support from two parents (rather than just one) can be challenging in several situations.
If pharmaceutical and biotech companies specify that consent is only required from one parent or guardian, they will almost always be more successful in enrolling participants for pediatric trials.
Choose a CRO (contract research organization) aware of the specific needs of pediatric trials because children are not miniature adults. The success of your trial depends on the design of child-friendly protocols.
Investigate Trial Protocols That Are Suitable For Children
Trials for children should be easy for participants and families. Minimizing the inpatient component is one method for streamlining trials and increasing their viability.
Pharmaceutical and biotech companies can look into opportunities to observe and gather data from pediatric trial participants outside of the clinical setting rather than requiring frequent clinical visits from participants.
For instance, kids taking part in studies on the treatment of ADHD have been instructed to keep journals at home. This enables shorter clinical visits while maintaining data collection. The use of remote monitoring tools, such as blood glucose or heart rate monitors, to take readings and report data during trials offers an alternative to journals.
Children who are taking part in clinical trials (and their families) may be able to do so with fewer in-person clinical visits if remote monitoring devices are used. Blind trials that shorten the placebo period and give participants an extension are another pediatric-friendly protocol.
Provide Assistance To Carers
Participation in pediatric trials will eventually decline if families are under too much stress. Trials are more effective if support is provided to parents and other carers to lessen the impact on family life.
It is crucial to have coordinators for pediatric trials who are skilled at speaking with parents and children. More questions or detailed explanations of clinical procedures may be requested by parents who are worried about their child’s health than is typical of adult trial participants.
Pediatric trial coordinators should have good communication skills, be kind to children and adults, and be patient. Of course, demonstrating support for carers entails more than simply keeping in touch with them.
It is necessary to make trial participation as simple as possible during and between clinical visits to support carers fully. For instance, if parents and other carers have a designated area to wait during treatments, it will be more uncomplicated and more comfortable for them to attend clinical visits.
Parents might need to use this time to catch up on work on their laptops or entertain other kids who are with them and need to be fed or entertained. In-office treatments become less inconvenient by offering a comfortable space for carers to make the most of their time during clinical visits, which boosts completion rates.
Pediatric trials, which need many parents willing to sign their kids up for trials, will continue to be in demand. Finding and supporting the young volunteers and their families takes a unique strategy.