Your involvement is essential to the success of our medical research. Find out all the important information you need to get involved in our exciting studies and help improve health for all here.
The aim of clinical research is to develop drugs, either by developing new molecules or by adding new indications to existing molecules. It costs around $1 billion to develop a single drug and takes from 10 to 15 years, divided into several stages. Here are the main stages of clinical research:
At this stage, the drug is tested in test tubes and on animals. Lasts about 6 years.
First human trials. Involves a small group (10-50) of healthy people and lasts about 1 year. Used to verify the drug’s safety (possible side effects).
At ALPHA RECHERCHE CLINIQUE, we conduct phase II, III and IV studies.
Involves a few hundred people with the health problem for which the molecule is designed. Used to prove the efficacy of the treatment (sometimes compared to a placebo, which is a molecule containing no active treatment). This phase is also used to determine the optimal dose for the next phase. Usually lasts between 1 and 3 years.
Involves 1000 patients or more per study. Used to confirm efficacy, prove long-term safety, detect possible interactions with other existing drugs and determine the risk/benefit ratio. Phase III is also used to compare the efficacy and safety of the molecule studied with that of the standard treatment normally used. It lasts between 1 and 7 years. Following this phase, the drug can be registered (marketed).
After the drug has been marketed, further studies may be necessary, either to broaden a product’s indication (e.g. Tylenol has several indications, such as 1- pain and 2- fever) or because of recurring medical problems. Thousands of people per study.
Telephone contact by a nurse and explanation of the study in detail (e.g. number of visits, duration of the study, possible side effects, patient involvement). An initial assessment of the patient’s eligibility (according to the criteria for participation in the study) will also be carried out.
Our team of healthcare professionals stands out for its humane and respectful approach
01
During the first visit you will meet with one of the studyâs research coordinators. This meeting always begins with the reading of consent where you will have the opportunity to ask your questions. If you agree to participate in the study, you will be asked to sign the consent
02
Once the consent has been signed, the Research Coordinator will ask you some questions in order to know your medical history. Each search protocol is unique and has a list of inclusion and exclusion criteria. She will also perform some of the procedures required by the protocol. Here are some examples (vital signs, electrocardiogram and blood tests). This data will help assess whether you are potentially eligible for the study. The interventions performed and the duration of this period is unique to each study.
03
In case you meet all the criteria requested by the study, you will be able to be randomized, which means you will be able to start the study medication
04
During this phase, you receive study medication. There will also be follow-up clinic visits. Some studies also include telephone visits. The coordinator will assess your health by asking you a few questions and collect some data by performing some of the interventions required by the study protocol.
05
This phase begins when you complete study treatment. The duration and number of visits vary depending on the protocol, but it usually consists of an additional visit approximately 2 to 4 weeks after stopping treatment. The follow-up allows to conclude the study safely. If additional testing is required, the coordinator will contact the medical investigator for additional testing.
In order to reassure you about your first experience in clinical research, Alpha-Recherche offers professional and warm care. Here are some benefits of participating in a clinical trial.
Regular health checks throughout the study
Nurses, family physicians, neuropsychologists, neurologists, gastroenterologists, radiologistsâŠ
Personalized care according to your needs
Your personal involvement in the development of new drugs
Study drugs provided free of charge during your participation
No fees to pay for participation (financial compensation usually covers travel expenses)
Check out our frequently asked questions to quickly find answers to frequently asked questions. We are here to enlighten you and accompany you throughout your experience with us.
You can contact us by phone at the clinic of your choice depending on your location or you can complete the form in the Contact section. We can then answer your questions and check your eligibility according to your interest.
Your participation in a clinical study is voluntary and nothing can be done without your free and informed consent. If you decide to accept, you can stop your participation at any time without having to justify the reason and without having to suffer any consequences. Your decision will have neither impact on the quality of care received nor your relationship with clinic staff. Your possible participation in other clinical trials will not be compromised.
Your participation in this study will not cost you anything. You will receive an allowance that consists of financial compensation to cover your travel expenses.
No, the money you receive as financial compensation during your clinical study visits should not be reported for your taxes.
In a randomized Phase 3 study, that is, treatment is compared to another treatment, no treatment or placebo, there is the possibility of receiving placebo. It is an inactive product, a âflour pillâ, substituted for a drug to test the psychological mechanism of the study medication. It therefore has no pharmacological or therapeutic effect.
Usually not, unless the study is phase 4. The advantage of participating in a study is to access a drug before it is marketed. And for some diseases, the only way to access treatment is through clinical trials because no drugs are available.
The clinical trials are divided into four phases, we are conducting Phase 2-4 studies:
Phase 1 : The drug is evaluated on a small group of voluntary and healthy subjects to assess the safety of the drug, tolerance, determine a safe dosage and detect side effects.
Phase 2 : Trials are conducted on a larger number of participants (100 or more) and they must have the desired health condition. The objective is to determine the effectiveness of treatment on a particular disease or disorder and to determine the optimal dosage by checking for efficacy and tolerance.
Phase 3 : Trials are conducted on an even larger number of participants (1,000 or more) and they must have the desired medical condition. These randomised trials aim to compare the drug tested with an effective treatment already on the market or placebo. The goal is to determine the benefits versus the risks and gather any information that will allow it to be used safely before it enters the market.
Phase 4 : These clinical trials are carried out following the commercialization of the drug, that is, its marketing. It has several hundred to several thousand participants. The aim is to verify on a large scale and under real conditions of use the effectiveness, benefits and adverse effects that have not been highlighted in previous phases.