At any one time, Penn Medicine investigators run as many as 3,000 studies involving human subjects, generating knowledge about disease and finding new cures. And making sure these studies run smoothly are 700 clinical research coordinators who do everything from recruiting patients and administering medication to collecting the data that proves – or disproves – the study’s goal.
“The principal investigator is the brain of the research, and the coordinators are the hands,” said Jun Mao, MD, of Penn’s Family Medicine and Community Health. “The brains and the hands have to coordinate, but, without the hands, nothing can happen.”
Clinical research coordinators come from many backgrounds. Some are medical students while others are nurses or college graduates with an interest in research. All are required to undergo special certification training.
Maureen Prewitt, director of Clinical Research in Oncofertility, comes from a nursing background. While working in Labor and Delivery at the Hospital of the University of Pennsylvania –- an academic medical center -- she had the opportunity to contribute to research. She made the switch to fulltime research -- in oncofertility -- in 2006.
Oncofertility studies address fertility among women who are treated for cancer with radiation or chemotherapy. Studies have shown that some chemotherapeutic interventions cause premature aging of a woman’s ovaries and early menopause. “With improvements in cancer treatment, we have the wonderful challenge of attending to quality of life issues in survivors,” said Prewitt, who runs these trials as part of Penn’s Preservation Fertility Program. “And, for many women, the opportunity to become a mother is a significant quality of life issue.”
Their mission is to increase awareness of the risk of infertility among survivors. Regular menstrual cycles can sometimes mislead young women into thinking that fertility is unaffected. Prewitt's team regularly assesses an individual’s risk of infertility.
When fertility is compromised, the program offer opportunities to freeze a woman’s fertilized or unfertilized eggs or ovarian tissue. With some potential subjects, those decisions have to be made very quickly, before treatment with fertility-damaging chemotherapy or radiation begins. Still, having a plan in place for fertility preservation frees many women to focus entirely on getting well. “The hope of future pregnancy or surrogacy is powerful medicine!”
And when a survivor returns to introduce Prewitt to her baby, “that is the best reward of all.
“My subjects are exceptional people. I am inspired by the courage I see in them every day,” she said. “Their willingness to give us their time, their intimate information, their emotional energy … This generosity of spirit has gained my deepest admiration.”