Clinical trials would not be possible without the clinical research assistants and coordinators who organize and operate the logistics of each trial. Before patients are enrolled in a trial, the clinical research assistants are trained on the trial’s protocol to learn how the drug works and what side effects might be expected.
When patients are identified as eligible for a particular trial, the clinical research assistants send the patient’s tissue samples for testing, book all the blood, heart, skin, hearing and other physical tests and CT scans required to be enrolled in the trial. There is a large ethical component with each trial, and research assistants help patients understand and navigate the consent process.
During the trial, the clinical research assistant maintains contact with the patient and monitors how they are doing, keeping detailed information about the patient’s reactions or any drug and side effects. The information gathered is input into a database that will determine the effectiveness of the trial’s treatment.
“At the moment, I coordinate seven different clinical trials at The Ottawa Hospital. I would say for any given trial, we have between seven to 10 patients enrolled. For more common cancers, such as colorectal, we usually get 15 to 20 patients enrolled in the trial.
The drugs given in the chemo unit at the Cancer Centre have all been rigorously tested. Before Health Canada approves a drug for standard of care treatment, it has to be proven effective and safe. This is the purpose of clinical trials. It’s all about looking at the way patients tolerate the medication, assessing their side-effects, and monitoring the CT/MRI scans to determine if the drug is working. We go through a whole list of symptoms to see if he or she is experiencing any of them. If the patient has unexpected side-effects that we feel are related to study treatments, we report it to the pharmaceutical company immediately.
Often the clinical trial protocols are designed to determine the drug dosages. We have a starting dose and adjust it to suit the patient to reduce the toxicities. We may lower the dose by a quarter or even a half, if they have bad side effects, and see if the new dose is as effective and has positive results. We do a rigorous, continuous assessment of how well each patient is doing on the drugs. The patient continues to undergo a number of tests throughout the trial to monitor how well they are doing.
Now, a lot of pharmaceutical companies are trying to design chemotherapy drugs given in a pill form, so that patients can take them at home and not come to the hospital to receive the chemo drugs intravenously. With an effective pill form, patients would be able to spend more valuable time with their family instead of spending time driving to the hospital and sitting for hours for their treatment.
Patients can be on the drug they receive in a clinical trial for as long as they are benefitting from it, even once the trial has ended.”