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Only through research will we achieve our goal of ending MS
For patients with multiple sclerosis, their families and caregivers, the decision to participate in receiving an experimental treatment or enter a clinical trial is a challenging one. The MS Clinic is actively involved in performing MS Clinical trials. MS clinical trials are carefully designed research to determine the effectiveness and safety of a drug or device in humans.
Frequently asked questions
- What is the difference between a research study and a clinical trial?
The UBC Hospital MS Clinic is involved in many different kinds of research. Research helps us gain knowledge to find new treatments and cures. There are two types of research. Researchers conduct research to test scientific developments. There is also research that involves humans and this is called clinical research. There are many different types of clinical research but clinical trials investigate new drugs, combination of drugs, drug treatments and medical devices.
A clinical trial must be done before a new drug or device can be marketed to the general public. A clinical trial has three main goals:
- Safety: The clinical trial must prove that a medication or medical device is safe for use by the public.
- Effectiveness: The clinical trial must prove that the new medication is effective.
- Side-Effects: The clinical trial must ensure the new medication has few side-effects to cause harm.
Clinical trials are closely regulated and investigators must be given permission to test a new drug under extremely strict regulations.
- What are the Phases of Clinical Trials?
Phase I trials (Rarely done at UBC Hospital MS Clinic) – Researchers test an experimental drug or treatment in a small group of volunteers to evaluate safety, determine safe doses and identify side effects.
Phase II trials – Researchers test an experimental drug or treatment which is given to a larger group of volunteers to investigate the effectiveness and to further evaluate its safety. Researchers compare the responses of the group given the treatment to others given a placebo or other medication.
Phase III trials - The experimental drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and determine the potential side effects of the medication, the long-term effects and any complications that may occur.
Phase IV trials – Post marketing studies conducted to determine long-term risks, benefits and overall optimal use.
- Who can Participate in a Clinical Trial?
Each clinical trial has a different criteria for who can participate and strict requirements, eg. age, current health and medical history. In order to take part in a clinical trial you must agree to be involved in that particular study. Your physician will ask you if you are interested in taking part in a particular study if he/she thinks you qualify for that study.
In order to be included in a clinical trial you must agree to be involved and you may drop out of the research at any time. Your present and future medical care at the MS Clinic will be the same whether or not you agree to participate.
All clinical trial procedures, risks and benefits are explained in detail in the letter of information and consent.
- What is Informed Consent?
Potential participants in a clinical trial are given information documents by those overseeing the trial which clearly explain:
- the study purpose
- study procedures
- length of the study
- benefits and risks of taking part in the trial
- what other treatments are available
- taking part is your choice
- participants may ask questions or withdraw at any time before, during or after the trial.
Participants will also be asked to sign a consent form which will also indicate the “Principal Investigator” you should contact if you have any questions or require any additional information.
Research staff will always safeguard your health and put the patient’s interest first and foremost.