According to the National Institutes of Health (“NIH”), a Clinical Study is medical research that involves the use of human volunteers (called study “subjects” or “participants”). The research is intended to add to medical knowledge, improve therapies and lead to better medical outcomes. There are two main types of clinical studies: clinical trials and observational studies.
Evidenced based medicine requires thorough documentation and review of existing and new or evolving therapies. But in order to prove new treatments are safe and effective, all medications, medical devices and medical procedures have to undergo medical research. This is where and how the Clinical Studies program at Growing Child Pediatrics, PA gets involved. The program is crucial to making advances in medicine and aiding the care of our patients.
In the United States, clinical trials are offered to adults, adolescents and children with a wide range of conditions and illnesses. These studies are regulated by the FDA and governed by an Institutional Review Board (“IRB”) comprised of doctors, researchers and members of the community. The IRB’s role is to make sure that the study is ethical and that the rights and welfare of participants are protected.
But why do studies on kids? As I am sure any middle aged parent has realized…..children and adults differ in physiological capabilities and metabolisms as well as the severity and type of disease and the average healing time. Moreover age, growth and development influence side effects and the dose of medications is often dependent on body size or weight. These differences often overwhelm the ability of modern science and researchers to correctly predict the effect on young people solely by extrapolating of data from studies of the adult population. Simply put, it would be unethical to treat large numbers of children using treatments, the effects of which were only studied in adults.
Participants (and the parent/guarding’s) understanding of the purpose, methods, risks and consent is the cornerstone of protection for human subjects, especially when the research participant is a child. Parents are expected to act in the best interest of their child and hence have been entrusted with the responsibility of providing permission/approval for enrolling their children in a research study. This process is called Informed Consent and it is how every volunteer begins their study participation with the GCP team.
2015 Duke Quality Improvement Project on Sleep and Reducing ADHD Symptoms
Last year, we were fortunate to be the primary clinical site for a Duke University School of Nursing study into the benefit of a provider-instructed, sleep hygiene routine which addressed the impact of screen time (from TVs, computers and mobile devices) on sleep in children, ages 5-11 years, affected with ADHD. The quality improvement project utilized a pre-posttest design to evaluate the effects of the sleep hygiene routine on sleep duration, ADHD symptoms and family quality of life. The detailed results of this study will be published later this year.
2016 Pearson Quotient iPad Study
Currently, GCP is working with NCS Pearson on the Quotient iPad Normative Database study. This study is being conducted to create a database for the new Quotient® System iPad Test. Using a representative cross-section of ages, genders and ethnicities of healthy subjects (called “community sampling”), the results of this study will be compiled to create a baseline dataset against which the results of future clinical Quotient tests may be compared. Down the road, a patient’s performance can be determined by comparing their actual results relative to this baseline for a specified developmental age and gender. It is believed that this will be an effective, objective diagnostic tool to help providers assess a number of mental diagnoses.
Those wishing to participate (after a short enrollment pre-screening), will provide written informed consent, answer a brief self-assessment questionnaire and then complete the 15 minute Quotient test. The study will be open to healthy individuals between the ages of 6 and 80 years of age.
If you or your child would like to participate in any of our academic or clinical studies, know that you will be under the care of Growing Child’s providers, specialty-trained nurses and other professional research staff. All studies are completely voluntary and you can discontinue participation at any time.
If you would like further details, please contact Molly Milani at 919-488-0015 x 1213 or send an inquiry to Study@GrowingChildPediatrics.com.
Jeff T Goller, CPA – Chief Financial Officer of Growing Child Pediatrics, PA