When someone does not know which treatment the patient is receiving e.g. placebo or actual treatment.
Single-Blinded Trial – When only the patient does not know whether they are receiving placebo or actual treatment.
Double-Blinded Trial – When the oncologist, clinical trials research team, the patient, and others involved in the patient’s medical care do not know whether the patient is receiving placebo or actual treatment. Double-blinded trials are used more often than single-blinded trials when blinding is needed.
Unblinding – The process of revealing what treatment the patient is receiving. In certain circumstances, such as a medical emergency, a patient may be unblinded.
- Clinical Research
Research that involves people who volunteer to participate.
- Clinical Trial
A carefully designed and supervised research study involving people. Clinical trials may involve treatment, such as drugs or devices, or an intervention, such as procedures or techniques.
Treatment Trials – The use of drugs, radiation, surgery, and/or devices to treat cancer. The goal of treatment is to get rid of, stop, slow, or reduce the growth of your cancer.
Intervention Trials – The use of investigations, procedures or techniques, such as blood tests to detect cancer, newer methods to scan for cancer, or prescribed diet and exercise programs. The goal is usually to prevent cancer, detect cancer earlier, or improve symptoms.
Trials that are no longer enrolling new patient either permanently or temporarily during interim analysis. If the trial is closed temporarily, the trial is “suspended.”
- Compassionate Release / Expanded Access Clinical Trial
When a clinical trial shows positive results, the sponsor may allow more patients to have access to the treatment while still being part of a clinical trial. This is a way to help patients get new treatments that are not yet approved.
- Control Group
The group of patients receiving a placebo or standard treatment.
- Data Safety Monitoring Boards (DSMB)
An independent group of experts who analyze the information gathered from a clinical trial to monitor patient safety and the effectiveness of the treatment or intervention while the trial is still ongoing.
An instrument that is being tested on patients for safety and effectiveness such, as a machine delivering electrical impulses.
- Eligibility Criteria
Carefully designed criteria which all potential patients must meet to be able to join a specific clinical trial.
Inclusion criteria – Criteria that allows a person to join, such as diagnosis, gender or, age.
Exclusion criteria – Criteria that, if present, do not allow a patient to join, such as blood test results or the amount of previous treatment received.
When a patient joins a clinical trial, they are registered, or enrolled, into the trial.
Rules based on what is right and what is wrong. In clinical trials, the Research Ethics Board (REB) is an independent group that reviews the ethics of clinical trials to ensure patients’ rights, safety, and wellbeing are protected. REB approval to begin a clinical trial is given when all of their questions are answered appropriately. Every clinical trial is reviewed by the REB annually to make sure that the trial is going well and there are no concerns or complaints about the trial. The REB reviews clinical trials to ensure that:
The oncologist conducting the trial is qualified
The trial is well planned and may be successful
The benefits of the new or experimental treatment or intervention outweigh the possible risks
The informed consent form is complete and easy to understand
Patients will not be forced to participate
Patients have the right to contact the REB at any time if they have any questions, concerns, or complaints about a clinical trial.
- Experimental Group
The group of patients who are receiving the new, experimental treatment.
- Good Clinical Practice (GCP) Guidelines
An internationally accepted set of rules for conducting clinical trials. GCP guidelines ensure patients’ rights, safety, and wellbeing are protected and clinical trials are conducted with a high-level of quality.
Treatments to boost or suppress the immune system in fighting cancer.
- Interim Analysis
When information collected during a clinical trial is analyzed before the trial is complete. Results may be good or bad. If the researchers find the new treatment has a positive benefit, compassionate release through an expanded access clinical trial may be allowed. If the results are bad, the trial is required to stop.
Doctors who specialize in treating patients with cancer.
“Coming soon.” These are clinical trials that are undergoing regulatory review and approval before they can be offered to patients.
- Pill Diary
A diary used by patients to record their doses of treatment. Usually, the patient must record the date, time taken, dose, and any side effects.
Pills, liquids, or powders that look like the actual treatment but have no medical ingredients, like a sugar pill or saline solution. Placebos are used in cancer clinical trials when there is no standard treatment for comparison to the experimental treatment.
- Primary Care Team
A multidisciplinary team of health care professionals who work together in providing care to a patient.
- Principal Investigator
The oncologist in charge of the trial.
Patients are assigned by chance, like flipping a coin, to the different treatment groups being compared in a clinical trial. Some patients are assigned to the experimental treatment and others to the control group. This is done to prevent bias in evaluating the trial results, meaning every patient has an equal chance of being in either group and that patients are not chosen for either group in a way which could affect the clinical trial results.
The hospital or cancer centre which enrolls patients into a clinical trial.
The regulatory review is complete and the trial is open for patients to join.
Sets of rules which must be followed. Health Canada regulates all clinical research done with drugs, biologics, devices and health products. In addition, International Good Clinical Practice (GCP) Guidelines must be followed when conducting clinical trials. This is to ensure patients’ rights, safety, and wellbeing are protected. Inspectors may visit the hospitals or cancer centres conducting clinical research to ensure regulations are being followed.
- Response Rates
Response refers to how the treatment is affecting the cancer. The effectiveness of a cancer treatment is determined by the number of patients in a trial who have a:
Complete response – The cancer disappears,
Partial response – The cancer shrinks,
Stable disease – The cancer stops growing for grows more slowly, or
Progressive disease – The cancer continues to grow.
Response may be determined by scans, physical examinations, blood tests and/or biopsies.
The person, organization, or company who is in charge of the clinical research and funding the clinical trial. Sponsors are usually academic groups, pharmaceutical companies, government agencies, or Principal Investigator.
- Standard of Care
The current, best, approved treatment given for a specific type and stage of cancer.
- Stereotactic Radiosurgery
Ways to do surgery using radiation, such as the Cyberknife.
- Targeted Therapy
Drugs to target specific molecules on the surface or inside cancer cells.
- Treatment Groups
In clinical trials that compare one treatment to another, patients are enrolled to either the control group or the experimental group.
Control Group – The group of patients receiving a placebo or standard treatment.
Experimental Group – The group of patients who are receiving the new, experimental treatment.
By comparing the difference between the control group and the experimental group, the effect of the new treatment is better understood.
- Trial Status
Clinical trials may be pending, open, or closed to enrollment.
Pending – “Coming soon.” These are clinical trials that are undergoing regulatory review and approval before they can be offered to patients.
Recruiting – The regulatory review is complete and the trial is open for patients to join.
Closed – Trials that are no longer enrolling new patient either permanently or temporarily during interim analysis. If the trial is closed temporarily, the trial is “suspended.”
The process of revealing what treatment the patient is receiving. In certain circumstances, such as a medical emergency, a patient may be unblinded.
An inactive virus that helps your immune system to attack and destroy cancer cells.
- Wash out period
A period of time defined in the protocol that must pass in between the last dose of a previous treatment and the first dose of the clinical trial treatment. This ensures that the previous treatment is eliminated, “washed out,” from the patient’s body so any side effects or cancer response can be better studied.