WHAT IS CLINICAL RESEARCH?
Clinical research’s objective is to develop medication, both by finding new molecules and by finding new properties for existing ones. It may cost about 1 billion dollars and it may take 10 to 15 years, divided in several different steps, to develop one medication. Here are the main steps of clinical research:
Pre-Clinical Study: At this stage, medication is tested in test tubes, as well as on animals. This step lasts about 6 years.
Phase I: First trials on human beings. They are conducted in small groups (10 to 50) of healthy people and they last about 1 year. They make it possible to verify the innocuousness of the medication (the possible side-effects).
At ALPHA CLINICAL RESEARCH, we conduct phase II, III and IV studies.
Phase II: It is conducted with groups of hundreds of people who have the health problem that the molecule has been designed to solve. It is used to prove the efficiency of the treatment (sometimes compared with a placebo, which is a molecule that does not contain any active treatment). This phase also makes it possible to determine the optimal dosage for the next phase. It usually lasts between 1 and 3 years.
Phase III: It is conducted with 1000 patients or more per study. It is used to confirm the efficiency of the medication, to prove its long-term innocuousness, to detect possible interactions with other existing medications and to determine the risk/benefit ratio. Phase III also allows us to compare the efficiency and the innocuousness of the studied molecule to those of the standard treatment that is normally used. It lasts between 1 and 7 years. After this phase, the medication may be registered (released on the market).
Phase IV: Following the market release of the medication, other studies may be necessary. They are used to either widen the indication of a product (ex: Tylenol has several indications, such as 1- pain and 2- fever) or because there has been recurring medical issues with it. It is conducted with thousands of people per study.
Overall procedure of participation:
A nurse reaches people by telephone: Detailed explanation of the study (ex: number of visits, length of study, possible side-effects, patient’s involvement). A first evaluation of whether or not the potential patient meets the criteria of participation in the study will also be conducted.
If you are interested and meet the criteria:
1st visit of the centre: You’ll be asked to read and sign a consent form that provides all the details regarding the study. Before anything else is done, the nurse and the doctor in charge will take the time to answer all your questions. The participation in a study is always done on a voluntary basis, and so you are in your right to decide to interrupt your participation at any time.
Follow-Up: We may then conduct the first evaluations, or you may come back another time. The very first evaluation will consist of a health check, performed in order to confirm your eligibility. The health check will be conducted using different tests, such as blood tests, electrocardiogram readings, checking of blood pressure, and/or other tests.
Studied medication: Once your eligibility is confirmed, you will begin treatment with the medication that is being studied. A regular follow-up will then be done, at different intervals, according to the requirements of the protocol in which you are participating. The doctor and the nurse in charge will take care of you throughout the study. Of course, we will make sure to consider your availability for the following visits.
(Please note: in general, all of this work is done at the ALPHA CLINICAL RESEARCH centre; you will thus not have to commute anywhere else.)
The advantages of your participation:
- Regular and easily accessible medical follow-ups, by both doctors and nurses;
- Regular health checks throughout the study;
- A multi-disciplinary team (nurses, family doctors, neuropsychologists, neurologists, gastroenterologists, radiologists…);
- Personalized care according to your needs;
- Personal involvement in the development of new medication;
- Studied medication provided for free for the length of the study;
- Participation is completely free of any charge (a financial compensation generally covers the commuting expenses).