Clinical trials are controlled research studies or experiments that test newly developed procedures, drugs or equipment on consenting individuals, usually patients, who have been diagnosed with a serious health condition such as heart disease, stroke or cancer. These trials endeavor to determine whether a new treatment option, drug, or other intervention is safe, effective and better than current standard protocols. They are an important step in the discovery of new medical advancements that can result in longer or improved quality of life for many people.
The Thunder Bay Regional Health Sciences Centre, Thunder Bay Regional Research Institute and the Regional Cancer Centre features designated space for clinical drug trials and actively participate in a number of clinical trials. We believe that active involvement in clinical trials is essential for a high quality program and participation by all our programs is highly promoted. Our patients will have access and option for participation in appropriate clinical trials.
Phases of Clinical Trials
Clinical trials are conducted in four phases. Each phase has a different purpose in the research process:
Phase I |
The first step involves testing a new treatment (e.g., drug) for the first time on a small group of people to evaluate its safety, determine a safe dosage range, and to identify possible side effects. |
Phase II |
Usually focuses on a particular type of disease (e.g., high blood pressure). It continues to test the safety of the treatment and begins to evaluate how well it works (e.g., reduced blood pressure, side effects, etc.) |
Phase III
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The trial treatment is given to a larger number of people to confirm its effectiveness, monitor side effects, and to compare it to commonly used treatments. During this phase, participants are randomly (i.e., by chance) assigned to receive either the trial treatment or a placebo (an inactive pill, liquid or powder). Randomizing patients allows the researchers to compare individuals with high blood pressure while taking different treatments to better determine which treatments are better and have fewer side effects. |
Phase IV |
These studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects related to long-term use. |
It is through clinical research that improvements or advances are made in the prevention, detection, and treatment of cancer and other diseases. Clinical trials could include:
- Prevention trials to test ways to stop disease from starting or returning. The focus of these trials may include drugs, vitamins, minerals, natural health products, educational programs, and lifestyle or behavioural changes.
- Diagnostic trials to find better tests or procedures to help identify or find a specific disease or condition.
- Treatment trials to test treatments, drugs, combinations of drugs, medical devices, natural health products, or new approaches to surgery or therapy.
- Quality of life trials to look at ways to improve comfort and the quality of life for people with a chronic disease, disability or condition.
- Chart Reviews of existing medical records that are intended as a systematic analysis designed to contribute to generalizable knowledge.
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Clinical research conducted at Thunder Bay Regional Health Sciences Centre incorporates these types of studies offered through, pharmaceutical companies, cooperative groups or in-house research. The cooperative groups offer studies that are among the foremost in research for cancer treatment, prevention and diagnosis. Groups such as the National Cancer Institute of Canada (NCIC) or Radiation Therapy Oncology Group (RTOG) often partner with cancer research leaders such as the Mayo Clinic or MD Anderson, so patients participating in these studies at RCC have access to some of the most innovative and cutting edge treatments, tests or prevention tools available.
For more information on current open clinical trials at TBRHSC, click here and search for "Thunder Bay" under Find a Trial. You can also obtain more information at www.clinicaltrials.gov or by calling 807- 684-6044
The future of clinical trials at TBRHSC
The Thunder Bay Regional Research Institute (TBRRI) will inspire a whole new approach to clinical trials at the Health Sciences Centre. The TBRRI will bring research from the bench to the bedside in the area of molecular imaging - and clinical trials will be the bridge.
For example, patients who required a positron emission tomography (PET) scan in the past have had to travel outside of Thunder Bay to have their scan under one of the approved clinical trials in Ontario. Now they can access a PET scan through a clinical trial right here in Thunder Bay.
Similarly, the introduction of a 3T MRI scanner ensures Thunder Bay will be one of only two Canadian sites that will offer the MRI-guided therapies in a clinical trial. |
