The ripple effects from such findings can be small, such as adjusting a dosage of medicine, or large, such as making a groundbreaking advancement in a surgical procedure. The individuals helped by study findings could be the patient’s child or grandchild—or a stranger on the other side of the world.
A successful study requires more than dedicated physicians and willing patients. It also takes a study coordinator, whose role includes working closely with the research team and the principal investigator (the physician who heads up the study) and serving as the primary contact for the patient and patient’s family. The study coordinator is crucial to the success of every clinical study.
Additionally, the study coordinator handles all communication between the research team and the study sponsor or organization, which might be a drug company or a government agency such as the National Institutes of Health. There are stringent regulations for these studies, and any protocol changes must be shared with the entire research team.
The study coordinator also does the extensive data entry related to a study, schedules patient exams, and completes case reports. Building strong relationships with patients is another large part of the job. Patient retention is an important part of any study and keeps study enrollees returning for follow-up visits.
“It’s wonderful to see how excited these younger patients and their parents are when vision improves and the treatment is working,” says Ann Holleschau, the study coordinator for pediatric ophthalmology. “There’s nothing more rewarding. The parents know that improved vision will have an impact on the rest of their child’s life.”
Because she specializes in pediatric ophthalmology, Holleschau often deals with families who have a genetic condition that may affect more than one of their children. Frequent topics for pediatric studies include treatments for amblyopia, where the vision in one eye is minimal or significantly reduced. Comparing treatments such as atropine drops versus eye patching has resulted in more options for children with amblyopia. “Studies like this make a big difference in families’ lives because some kids resist wearing patches,” says Holleschau.
Cook, whose position is now filled by study coordinator Jamie Walski, says the Midwest is regarded as a special place to conduct clinical studies. In talking with other study coordinators across the country, she found that enrolling patients who live on the coasts is often difficult. “People there were interested in getting in and out of the clinic quickly and simply getting treated without having any extra testing that a study might entail,” Cook says. “People in the Midwest, though, are more interested in doing what they can to advance the knowledge of a condition or treatment, knowing that it might some day help their children or grandchildren.”