Why do we do Clinical Trials?
Clinical Trials are required for every drug that is seeking approval from the FDA. We are the only pediatric clinic in the panhandle that participates in pediatric clinical trials.
3 CLINICAL TRIALS AT ACC PROVE HELPFUL IN THE FDA'S FEBRUARY APPROVAL OF A NEW MENINGOCOCCAL VACCINE. CLICK TO READ MORE.
Trials are done in multiple phases.
~Phase I trials enroll a small number of subjects and the focus of the study is on safety of the drug. Usually it is the first time this drug has been used in humans, or only a small number of humans have been studied.
~Phase II trials enroll a larger number than phase I and the focus is usually to determine the dose of the drug and a continued look at safety.
~Phase III studies enroll a large amount of subjects (thousands). By this time the drug dose is known and the drug company is looking at drug-drug interaction, risk versus benefit information, and dosing intervals. This is the final phase before FDA approval.
~Phase IV studies are after market studies, meaning they have been approved by the FDA for use but the drug company has agreed to continue following patients for an extended period of time for further information.
This clinic has taken part in multiple vaccine clinical trials, and several of them have been approved by the FDA and are now recommended for children! We most often participate in phase II or III studies.
It is very exciting to be a part of the research that leads to the approval of a new drug or vaccine! Many times it gives your child the opportunity to receive protection from a disease before anyone else in the world!
The first study done at this clinic was the Rotateq oral vaccine study that started in 2002. We enrolled around 960 infants in this study and the Rotateq vaccine was approved by the FDA for use in 2006. It is now the vaccine for rotavirus that all 2, 4 and 6 month old infants receive.
We started the study for the HPV vaccine called Gardasil in 2004. Our site enrolled 18 patients, both males and females, to receive this vaccine. Gardasil was approved by the FDA for female’s ages 9-26 years of age in 2006. We are still following a few patients in this study for after market data.
The next study we started was the Pentacel study in 2005. We enrolled 78 patients and this vaccine was just approved this year by the FDA. It will replace the Pediarix vaccine for children 2, 4, 6 and 15 months of age.
There is a big push to get a meningitis vaccine approved for infants right now. The highest risk groups for meningitis are infants, college kids and the elderly. The only meningitis vaccine approved on the market right now is for ages 2yrs and up. We have done studies for a meningitis vaccine in infants.
We look forward to speaking with you about being involved in one of our clinical trials. Your participation is always voluntary and you will never be asked to take part in any trial you do not feel comfortable with! If you have any questions please call the office!
