The marketing Authorization is issued by national or European authorities.
It follows the filing by the manufacturer of an application for authorization of marketing to these authorities.
Each case is studied to assess the quality of the product according to the efficacy and safety criteria and also the benefit / risk it presents.
Once granted, the marketing can be suspended or withdrawn at any time: risks to the patient, no proven efficacy, noncompliance with regulations (composition, packaging, instructions…)
= Contract Research Organization
It is a private enterprise specializing in clinical research. It thus supports clinical trials in one or more phases and that in one or several therapeutic areas according to their degree of specialization.
As part of a clinical trial, the Data-Management is the monitoring and verification of the accuracy of clinical databases. This database includes all the necessary information collected in clinical trials to determine the efficacy of the studied drug.
This is a scientific study applied to humans.
It aims to assess and prove the effectiveness of new drugs or new techniques of treatment, diagnosis, care or prevention but also to make sure that they are not or will not be harmful to the patients in more or less long term.
Clinical trials are conducted in four consecutive phases: Phase I, II, III and IV.
Each of these phases will have different objectives.
The new treatment or technique must meet the objectives of each phase to pass to the next.
To ensure reliable results, it is imperative that each study is conducted rigorously and proven to avoid any bias or any errors of data collection or interpretation.
CLINICAL TRIAL Phase I
- Check that the drug experienced in detail in animals is well supported by man.
- Evaluate the terms of administration.
- Study the side effects according to the ascending doses of treatment.
CLINICAL TRIAL Phase II
- Establish precisely the effects of the drug according to the doses and treatment modalities established in phase I.
- Deepening of study conducted in phase I with a larger number of patients.
- Assess the effectiveness and safety of new drug.
CLINICAL TRIAL Phase III
- Confirm treatment efficacy demonstrated in phase II.
- Compare the new treatment with other standard treatments usually used.
- Award of the type of treatment by random computer draw to ensure the objectivity of the results.
After this phase, if the real benefit and no risk to the patient are shown, the new drug receives the marketing authorization from the Ministry of Health.
The drug can be prescribed to all patients within the limits of its indications.
CLINICAL TRIAL Phase IV
- Large-scale realization.
- Observation of the effects of the new treatment in daily practice conditions.
- Highlighting the relationship between the observed benefits and risks of treatment.
The investigator takes over the completion of the clinical trial.
This is most often private doctors or hospitals that have participated most of the time on research.
The investigating physician must indeed justify specific skills to the studied field.
He will participate actively in the trial at the inclusion of participants in particular, by offering to his concerned patients to join the trial.
This is the process conducted by clinical research associates to verify that all data collected during the trial on the report forms are accurate, complete and consistent with the source documents.
The CRAs also verify that included patients respond well to predefined selection criteria and all SARs have been reported.