Why research is important in arthritis.
What is research?
Doing research means that you participate in one or more carefully planned clinical trials. They involve observing and treating people with certain diseases at the onset of symptoms or in the process of evolution.
-To develop or to discover new medications that will increase the patient’s quality of life, whether newly diagnosed or not, whether they never had treatments or are already on drugs;
- Validate new questionnaires or medical imaging tests that will help further research in these areas;
- To answer specific scientific questions regarding already known treatments for which new uses can be found or regarding new molecules that need to be proven effective;
- To allow the development of what might be called "generics or copies" of existing treatments. The research allows validation of their effectiveness and safety in comparison to the original drug.
All of these studies are done following a strict research plan called "protocol" that is established by researchers at the initiative of a sponsor (a pharmaceutical company, a university, a public or private health facility or even an individual). This protocol will be presented to physicians who will then become the investigators. There are four stages in the marketing of new treatments called phases. At the Montreal Institute of Rheumatology, we mainly participate in Phase III and IV studies.
To better understand these phases, you can watch the video below:
the video will be available soon
In a nutshell:
Phase 1: drugs tested for the first time in healthy humans. This phase is used to test the safety of treatment for humans.
Phase 2: Drugs are for the first time tested in people with the disease under treatment. This phase is used to determine the best dose to treat symptoms.
Phase 3: Drugs are tested for long-term side effects in people with the disease under treatment to see if it is more effective than another drug or if it is more effective than a placebo. These drugs are already existing treatments.
Phase 4: Drugs are tested to assess whether they remain effective when taken in everyday life and if they improve the quality of life of the participants. There are also registries in this category. Registries regroup thousands of other participants’ answers to questionnaires, providing an overall picture of the evolution of patients whose diseases are under study. There are no treatments tested in this type of research study.
What does a first research visit look like?
During your medical visit, your rheumatologist will assess whether you are a potential candidate for a research protocol currently underway at the Institute of Rheumatology. He will explain to you what the clinical trial is about and will introduce you to the nurse who supervises the study with him. She is the Research Coordinator. The nurse will evaluate your understanding of your medical condition, the available treatments and will confirm that you are interested in participating in a clinical trial. She will summarize current clinical studies, with their goals and constraints, unless you have already decided on one with your doctor.
Before you join a clinical trial, there are several steps to take:
- Consent (approved by an ethics committee) will be submitted to you. A consent is a document where all the elements (e.g., what is the drug being studied, how many visits are involved, what examinations will be done) are explained so you can make an informed decision. No procedure related to the clinical trial can be started until it is signed. You can read your consent at the clinic or if you prefer, take more time to understand it at home;
-we encourage you to have a discussion with your loved ones and your care team to fully understand your involvement in this clinical study;
-a phone appointment will be set a few days after the meeting with the coordinator to inform her of your decision. If you have any questions before this meeting, we remain fully available to answer them, whether they concern the search or not.
-if you agree to participate in the study, an appointment called the initial visit will be made at the clinic to assess your eligibility;
- Participation in a research protocol is voluntary and generally has little or no remuneration. If you refuse to take part in it or if after a while you think you are no longer able to continue, you can withdraw at any time. This will not change the medical follow-up that you should normally receive, be assured. Your rheumatologist may also decide to withdraw you from the study if he or she believes that your involvement involves risks to your health or if your illness is not well controlled by the treatment being tested.
What types of participants are we looking for?
The qualities sought in a participant are:
- honoring their appointments;
-their ability to understand instructions when some of the assessments are done at home, such as filling out a logbook or email questionnaires within the given timeframe, or injecting the medication on the dates agreed upon by the protocol.
If you would like to know more about the research, we advise you to view the video above or visit the Patients at heart website. We drew the information on this page from that website.