What you need to know about clinical trials
A clinical trial is research conducted on a human being to improve medical knowledge with ongoing experimentation. The clinical trial can be single-centre, including a small number of participants, or multi-centre, including thousands of patients. It is based on proven procedures and recognized statistical methods. Read this to learn all about clinical trials.
What is a clinical trial ?
A clinical trial is a scientific study carried out on volunteers to find out the effectiveness of a diagnostic method or treatment. This is a mandatory and necessary step, which requires the agreement of the health authorities of the country in which it takes place and a clinical research network. The duration of a clinical trial is variable, it depends on the results obtained at each phase.
It is most often offered at the initiative of a structure such as a university, a pharmaceutical laboratory, a public or private research institute, a hospital. Its purpose is to ensure that the new diagnostic or therapeutic approach provides greater benefit than the reference one. It can also have as its goal the search for an equivalent benefit but a lower risk or a higher benefit for an equivalent or lower risk.
The actors of a clinical trial
Several people are involved in carrying out a clinical trial. The patient is the main actor in any clinical trial. Its participation in the clinical trial is based on respect for fundamental human rights : freedom, dignity, consent, pain management, access to information. There is also the promoter who is a person or institution at the initiative of the clinical trial. It manages it and ensures compliance with the legislative provisions in force.
It can be a pharmaceutical laboratory, a hospital, a public research establishment. The promoter designates an investigator who directs and supervises the carrying out of the research on a given site. Except in special cases, it is generally a doctor who supervises the recruitment of patients according to certain criteria. Then we have a monitor. The monitor or Clinical Research Associate (CRA) is in charge of the implementation, control and monitoring of the progress of the research.