What is a Clinical Trial?
A clinical trial is an organized and detailed plan for investigating a new medicine, procedure, or device. At the University of Calgary, medical doctors (called investigators) conduct and supervise these trials. The trials receive approval from regulatory bodies such as the Federal Food and Drug Administration (FDA) and Health Canada, as well as the University of Calgary Conjoint Health Research Ethics Board (CHREB).
The CHREB is an independent group composed of people from all groups in society who ensure your rights are fully protected and you are not exposed to any unnecessary risks during a trial. Clinical trials are usually conducted in three phases - I, II, and III. A small number of people participate in Phase I trials. Each later phase involves a larger number of people. An informed consent form must be signed before anyone can participate in a trial. This consent form will provide you with all of the details about the trial and what is expected of you. A copy of this signed form is given to you for your information and personal records.
Participants are assigned to specific groups depending on the design within the trial. Usually, one group receives placebo.
A placebo is an inactive product that is known to be harmless and used to compare the results of the trial drug. In blinded studies, the doctor and the research staff will not know who is receiving real medication or placebo. In this way, the physician and research staff can observe participants in a clinical trial more fairly. Whether you receive the placebo or the investigational drug, the level of medical attention and care that you receive is the same.
After a clinical trial is entirely complete, all of the information is gathered from the sites that have participated in the clinical trial. Government medical advisors and specialists closely review this data to determine that the medication, procedure, or device is safe and has minimal or acceptable side effects. Only then will a new medication, procedure, or device be approved for use.
Even after a drug is approved for use in clinical care, companies may continue to conduct studies that compare the new drug to other drugs already on the market to be certain of its safety, effectiveness, and to monitor cost. Other research studies may determine if a therapy can be administered to children or special populations. Some studies assess a drug’s long-term effectiveness and its impact on the person’s quality of life. Infliximab (Remicade®), adalimumab (Humira®), and azathioprine (Imuran®) are examples of IBD medications that were, and continue to be, studied in clinical trials at the University of Calgary IBD Research Group.
Why Should I Participate in a Clinical Trial?
There are many reasons why people choose to participate in a clinical trial. Some may get involved simply to help medical research. Some may be suffering from a disease for which an approved treatment or even a good treatment does not exist at the present time. Some feel that they will get more personalized one-on-one medical care. When you participate in a clinical trial, you help in the development of new medical therapies that may offer better treatments for life-threatening and chronic diseases.
It is important that you have enough knowledge to make an informed choice before participating in a clinical trial. Please feel free to ask your physician or a research staff member about any questions or concerns you may have.
Should I Participate in a Clinical Trial?
Without volunteers, there would be no new therapies to fight illnesses.
Improving medical practice depends on clinical research. Clinical research provides doctors and health care workers with information on the safety and efficacy of new medications and treatments. In this time of limited resources, we need to be sure that the health care we provide is based on sound evidence.
What Will Happen to Me?
When you have enrolled in a trial, you will receive a physical examination and a research staff member will review your medical history. Other study-specific procedures, such as blood tests, ECGs, X-Rays, and Diagnostic Imaging tests, may also be completed.
During a clinical trial, your safety is the number one priority. You are strongly encouraged to ask questions and discuss your medical treatment with the investigator or research staff member at any time during the trial.
It is important that you take all your medication as instructed and at the right times, keep all of your scheduled visits, and answer the investigator’s questions honestly. The information that you give is valuable and important.
As a participant in a trial, you may have more contact with medical personnel. There is some evidence to suggest that patients involved in clinical trials do better than those not involved.
Your medical records remain confidential. The trial data that is provided to regulatory agencies, and when publishing final reports about the trial, will not include your name or the names of other individuals participating in the trial. If you change your mind, you may leave the trial at any time and for any reason. You will not be penalized in any way for not completing the trial.
Every participant in a clinical trial is important and valuable to improving clinical practice.