With kids back in school and pockets of school yard infections popping up, parents ponder how drugs become approved for their children
By Kathryn E. Vinson, MS, CCRC
Every year, back to school time brings its own sets of challenges for parents. From new clothes and back packs to sports physicals and making sure that vaccines are up to date, the list seems to grow longer with each passing year. With COVID-19 taking its place at the forefront of almost everything, parents also have the added worry of that condition on top of the typical cases of strep, flu, colds, and tummy bugs and the doctor’s appointments and prescriptions that those illnesses inevitably bring. With those concerns abounding, we here at DZS Clinical Services want to take some time to address them, as well as discuss our history in working with pediatric trials.
Despite what many in the lay public believe, pediatric trials do not start with a brand-new investigational medication straight out of the lab. After any investigational new drug, be it an antibiotic, an asthma medication, or a vaccine, has been proven safe and effective in adult populations, it can then begin pediatric testing if warranted.
Any trial involving a protected population can be tricky, and clinical trials with kids are no exception. In such trials, not only does the child or teen have to agree to participate, so does their parent or legal guardian. In these cases, the parent signs an informed consent document just as they would if they were the volunteer, while the child or teen signs an assent document. Assent documents contain much of the same information as the informed consent, but written in a language that is geared towards their age group. This can be burdensome for sites with limited staff; however, when partnering with DZS Clinical Services, sponsors and sites alike benefit from our team of experienced medical writers that can tailor an assent document to a multitude of age and maturity levels.
Much like the necessity for experienced consent and assent writers, protocol writers have the added challenge of writing a protocol that gathers the needed data, while being respectful of the fact that you are dealing with not just one person’s schedule, but two. In a similar vein, sites that choose to participate in pediatric trials must be able to accommodate before and after school appointments, which can stretch coordinator and lab time thin. Fortunately, DZS Clinical Service’s global network of experienced sites have proven histories of successfully completing pediatric trials.
With decades of combined experience in not only pediatric trials, but also respiratory, infectious disease and vaccine studies, DZS Clinical Services has been honored to be on the forefront of medication and device development that has been instrumental in saving the lives of countless innocent children. Whether working with a new antibiotic or a preventative measure against COVID-19, sponsors and parents alike can rest assured that their trial and their children will be treated with the highest respect. Contact one of our project managers today to find out how DZS Clinical Services is Your Direct Line to Maximized Trial Efficiency.