The conduct of a clinical trial photography goes through different phases. Each of them allows the effects of the molecule being tested and its efficacy to be monitored.
Discover the different phases of Clinical Trial Management
First phase: tolerance study
It consists of inoculating healthy volunteers with an increasing amount of the product and observing the reaction of patients under medical supervision. The information collected is transmitted to the data management centre, which checks its consistency and inserts it into the clinical trials database.
Second phase: dosing study
It allows to confirm the properties of the molecule on humans already observed in animals, to determine a dosage and to note short-term adverse effects.
Third phase: “pivotal” studies
Phase 3 trials are conducted on a larger number of patients and over a longer period of time. They specify the pharmaceutical properties of the molecule and the contraindications linked to its use. At this stage, the trial is analyzed and published. Its results are presented in a study report.
Fourth phase: monitoring of the drug
Once on the market, the molecule will be analysed throughout its commercialisation to study its therapeutic usefulness, the frequency of adverse effects and the occurrence of certain rarer cases.
Follow-up and documented management
A study cannot be initiated without the favourable opinion of the Committee for the Protection of Persons (C.P.P.) and authorised by the National Agency for the Safety of Medicines (ANSM) on the basis of a precise pre-established protocol. Reports on the occurrence of unexpected or risky effects for the safety of volunteers are also provided to the ANSM, which can decide on its suspension.
Throughout their process, clinical trials are regulated by health authorities. It is therefore essential to have reliable and accurate tools to collect and transmit the data essential to their conduct.