Clinical Research

Northpoint Pediatrics became involved in clinical research studies in 2009.   Clinical research studies are used to answer specific questions about new medications, vaccinations, devices, or therapies. Clinical trials may also be used to explore new ways of using existing treatments or involve the collection of data from patient health records to look at trends in the region or treatment outcomes.

You will see information regarding specific clinical trials in which we are participating posted on flyers at each of our offices and on our website.  You may be approached by your physician or nurse practitioner if your child qualifies for one of our studies.  Prior to entry into any research study a description of the study, including any potentials risks and/or benefits as well as any financial compensation, is carefully and clearly discussed with you.  Dr. Louise Tetrick is the Principal Investigator on all studies and Cleo Coyle, RN, CCRC, is the Director of Clinical Research and study coordinator.  To learn more about current research studies please call (317) 621-9199.

It is important to know that participation in a clinical trial is completely voluntary and consent may be withdrawn at any time and for any reason.  The medical care you are currently receiving from your pediatrician and pediatric nurse practitioner will in no way be affected by your participation, or lack of participation, in a clinical trial.

The majority of studies offer compensation for time & participation, tracking of data, or further testing whether it is lab studies, radiological studies, EKGs, etc that are study-related, and not part of your routine healthcare.

Study patients are monitored closely and carefully.  This allows for potentially picking up any health changes immediately, whether study-related or not.

Northpoint Pediatrics is participating primarily in Phase III Clinical Trials.  Phase III Clinical Trials involve patients directly or involve evaluating patient health records. In order for a drug, vaccine, or device to enter into Phase III Trials, that drug, device, or vaccine has successfully passed laboratory and/or animal trials, Phase I Clinical Trials, and Phase II Trials. 

• Phase I trials are completed on a small number of healthy volunteers, who are monitored extensively – usually around the clock and overnight or for several days in an inpatient unit.
• Phase II trials may only start after successful completion of Phase I Trials.  In Phase II Trials, study participants are selected from the general population because of the disease or condition for which the drug, vaccine, device, or treatment is intended.  If a Phase II Trial is completed without an adverse event or side effect, then a Phase III trial may begin.
• Phase III Trials are the last and therefore safest trials prior to a product receiving FDA approval and be available for the general population.  In order to enter into Phase III testing, there has been extensive investigation of the product, typically covering many years of study and evaluation.

We are excited about the opportunity to participate in medical research and hopefully many infant, pediatric, and adolescent patients will benefit from it as well.

For more information contact:

 Cleo Coyle, RN, CCRC, Director of Clinical Research
317-621-9199 ph  |  317-355-8722 fax