Hosting clinical trials in GRH’s cancer centre for the past 15 years has allowed our hospital to participate in the discovery of potentially life-altering cancer treatments and advance exceptional care for our patients. Just like patients, each clinical trial is unique and there are different rules, regulations, and reports required to keep the study on track.
As the ethics coordinator on GRH’s clinical trials team, Carol Ballantyne quietly keeps our close to 20 active oncology clinical trials running smoothly behind the scenes.
“It takes hours and hours to complete the correct paperwork required by Health Canada and other regulatory bodies before a clinical trial even begins,” says Carol. “Each clinical trial is unique – some studies have a lot more regulatory requirements and forms to complete than others. Ensuring the safety of the patients is paramount.”
A typical day for Carol means staying on top of the many moving parts of our clinical trials. Her day could be as routine as starting the ethics application for a new study which means working with ethics boards to make sure all aspects of the study are safe for patients to participate, a process that often takes weeks to months to complete.
Carol also prepares for visits from study sponsors (for example pharmaceutical companies or the Canadian Clinical Trials Group) that take the responsibility to initiate, manage or finance the clinical trial. This means working with study coordinators to review which patients and which studies the sponsor will be evaluating. Visits can be small, occurring over the course of a few hours, or larger, over a few days. Clinical trial teams are also subject to larger audits or inspections of individual studies where regulatory bodies like the Food and Drug Administration (FDA) or Health Canada visit onsite to review every detail of a study.
In 2017, the clinical trials team was chosen for a random routine inspection by the FDA.
"Last year’s FDA audit was definitely a highlight of my career,” Carol remembers. “An inspection that big is very rare, and it’s also very intense.”
Carol and the rest of the clinical trials team spent weeks in preparation for the inspection, double-checking study documents and patient files. The inspector was on site for a week, thoroughly reviewing these documents and asking questions of the study team.
When the inspection concluded, GRH received very good reviews. Carol remembers the experience as “a great learning opportunity”, and just another reason she loves her job.
“Clinical trials work is always evolving and growing. At the end of the day, we are doing this so we can offer patients new treatments that may not otherwise be available and to change the way cancer treatments are delivered.”