Members of The Ottawa Hospital’s Oncology Clinical Trials Office
What does it take to run a world-class cancer clinical trials program that tests new therapies and gives patients hope, time, and quality of life? At The Ottawa Hospital’s Oncology Clinical Trials Office, it takes a large and dedicated team of 60 staff who keep a few hundred cancer clinical trials going at any time.
“When a patient goes on a trial, we see them very often and develop quite a bond with them.” -Nancy Drummond-Ivars, Interim Senior Clinical Research Program Manager“I’ve seen patients who have exhausted conventional cancer treatments get a second chance thanks to clinical trials, be it improved quality of life or more time with their loved ones,” said Nancy Drummond-Ivars, Interim Senior Clinical Research Program Manager at the Oncology Clinical Trials Office. “They’re also giving an enormous gift to future patients, because every new therapy has to be rigorously tested before it can become standard of care.”
The Ottawa Hospital is a world leader in cancer research, thanks in no small part to the efforts of the Oncology Clinical Trials Office. The team has been nationally and internationally recognized for accurately following complex protocols and successfully recruiting patients to trials. For the sixth time in 10 years, they received the Investigational New Drug Program Team Award from the Canadian Cancer Trials Group in 2021. Companies that want to test a new cancer treatment will often reach out to the office because of this stellar reputation.
However, their most treasured accolades come from patients. “We’re often recognized by patients for our work, and it’s one of the most rewarding parts of our job. Our team members have received thank-you letters and been nominated for Gratitude Awards,” said Nancy. “When a patient goes on a trial, we see them very often and develop quite a bond with them.”
There are lots of moving parts to keep trials running smoothly, and teamwork is crucial. Learn about some of the roles that make cancer clinical trials possible.
Study coordinators become ‘part of the family’
“I like to tell patients ‘This is where I become part of your family,’ because the entire time they’re on the trial l will be seeing them often and asking questions about their health, their daily activities, and how they’re feeling,” - Kendra Christink, study coordinator
Study coordinators see a trial from beginning to end, and are the key contact for patients, physicians and the sponsoring company or research team. Once a new trial is approved by the ethics team, it’s assigned to a study coordinator and opens for recruitment.
When a physician flags a possible patient for a trial, the study coordinator meets the patient to explain the trial, go over the consent form, and answer any questions. If a patient agrees to join the trial and pre-screening tests confirm they’re eligible, the coordinator enrolls them into the trial.
“I like to tell patients ‘This is where I become part of your family,’ because the entire time they’re on the trial l will be seeing them often and asking questions about their health, their daily activities, and how they’re feeling,” says study coordinator Kendra Christink. “I follow cancer patients throughout the trial whether their outcomes are good or bad. The trials we work on are sometimes a patient’s last option, and unfortunately good outcomes are less common in those cases. But when we do have successful outcomes, that makes everything worthwhile.”
Kendra knows the challenges of the cancer journey firsthand. Twenty years ago her mother was approached to participate in a cancer clinical trial at The Ottawa Hospital.
“In pharmacy, we’re usually in the background, so we don’t see a patient’s outcome. With this job, you get to be a lot more involved in a patient’s care." - Vanda Theberge, pharmacy technician
“I know when my mom was on a trial it was great to have a study coordinator as an extra person on her team rooting for her and looking out for her best interests,” said Kendra, “I really feel for patients who come here alone with no other support person. I like to be there for them, even though I know emotionally it will be very hard for me.”
Clinical trial pharmacy staff help patients with new drugs
Patients on clinical trials are often testing brand new drugs that aren’t available at their local pharmacy. Instead, they get these drugs from the pharmacy staff at the Oncology Clinical Trials Office. Just like at a regular pharmacy, staff tell patients how the drugs need to be taken and how often, counsel them about side effects, and answer any questions.
"I’ve seen patients have better quality of life and more time with their families because of these new treatments” - Caroline Dean, pharmacy technician.
“It’s a very satisfying job,” says pharmacy technician Vanda Theberge. “In pharmacy, we’re usually in the background, so we don’t see a patient’s outcome. With this job, you get to be a lot more involved in a patient’s care, and that’s really rewarding.”
For each clinical trial, the pharmacy team needs to translate the often hundred-page study protocol into a quick summary they can refer to at a glance. Every study is very different in how the drugs are dosed and administered, and there’s a lot for this team to keep track of. But the results are worth it.
“I’ve been here for six years, and I’ve seen research drugs we’ve dispensed in studies become commercially available. I’ve seen patients have better quality of life and more time with their families because of these new treatments,” says pharmacy technician Caroline Dean. “To be part of that process is quite rewarding.”
Research nurses deliver treatments and compassion
“Everyone works so well together and they genuinely care about the patients, and that makes such a huge difference for people given a diagnosis like this."- Sara Ieradi, registered practical nurse.
Patients on clinical trials need to have blood samples taken regularly to measure how the treatment is working and to catch any side effects. A team of research nurses is responsible for taking these samples, in addition to administering chemotherapy and other medical treatments that are part of a clinical trial.
These nurses often see multiple patients a day for clinical trial blood work. These blood samples are pre-processed in the lab before being shipped to the sponsoring company for further analysis.
In addition to their research role, the nurses are on the lookout for any potential health issues a patient raises during a routine bloodwork visit, and they make sure the right care providers are notified.
“The group of nurses and lab staff here are phenomenal,” says registered practical nurse Sara Ieradi. “Everyone works so well together and they genuinely care about the patients, and that makes such a huge difference for people given a diagnosis like this. When you’re given a cancer diagnosis, that extra TLC from your nurse means a lot.”
Data managers get results to the right place
“I’ve been here 15 years, and there are drugs we did trials on that are now standard of care.”- Sopear Tep, data manager.
Between study visits, tests, and questionnaires, clinical trials generate a lot of data. Taken together, this data tells researchers which treatments work, which don’t, and what kinds of side effects to expect.
Keeping all this information straight and getting it to the company sponsoring the study within five business days is a full-time job for a dedicated team of data managers. One data manager can be responsible for up to 10 clinical trials at a time.
“Study sponsors are really grateful when we get them data in a timely manner, as they need this data before they can proceed to the next stage of the study,” says data manager Sopear Tep. “Delayed information could delay data analysis, and that can have a domino effect for all the other study sites.”
Data managers are also detectives, chasing down missing data and answering questions from sponsors about data they’ve already entered. For example, if a test result for a patient is abnormally high, a sponsor may need to know if the patient’s health was impacted.
“I love being part of a team that’s looking for something to help our patients,” says Sopear. “I’ve been here 15 years, and there are drugs we did trials on that are now standard of care.”
Clinician investigators ensure patients are well cared for
A clinician investigator is the physician responsible for a clinical trial at The Ottawa Hospital. They look after the safety and well-being of patients on the study, and make sure they receive the right care if they experience any side-effects. Clinician investigators also ensure all data collected during the study is accurate, and that patients’ rights and confidentiality are protected.
While a clinician investigator is the person ultimately responsible for the trial, these busy physicians are usually happy to delegate the day-to-day operations to the expert staff at the Oncology Clinical Trials Office.
“The Oncology Clinical Trials Office at The Ottawa Hospital is one of the largest and most active in the country,” said Dr. Rebecca Auer, Director of Cancer Research at The Ottawa Hospital and associate professor at the University of Ottawa. “The team has a proven track record of testing brand-new therapies for the first time in humans, right through to leading large multicenter studies that define new standards of care.”
“I am always impressed by the attention to detail, the dedication and the caring shown by the clinical research staff, as well as the investment of time and energy by clinician investigators who believe in the value of clinical trials for their patients today, and for those stand to benefit from the results in the future.”
Learn more about research clinical trials and how to get involved.
The Ottawa Hospital is a leading academic health, research and learning hospital proudly affiliated with the University of Ottawa and supported by The Ottawa Hospital Foundation.
