Clinical Research Associate.
Clinical Site Coordinator.
The marketing authorization is issued by national or European authorities.
It follows, in the submission by the manufacturer, of an application for marketing authorization with those same authorities.
Each case is studied to assess the quality of the product, according to efficacy and safety criteria but also in terms of the benefit / risk it presents.
Once granted, the marketing may be suspended or withdrawn at any time: risks to the patient, no proven efficacy, non-compliance with the regulations (composition, packaging, instructions…)
Contract Research Organization. It is a private enterprise specializing in clinical research. It thus takes over clinical trials on one or more phases, and in one or several therapeutic areas, depending on 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 information that was collected during clinical trials to determine the effectiveness of the studied drug.
This is a scientific study applied to humans. It aims to assess and demonstrate the effectiveness of new drugs or new techniques of treatment, diagnosis, care or prevention but also to check that they are not or will not be harmful to patients in more or less long term.
Clinical trials are conducted in four consecutive phases: Phase I, II, III and IV.
Each phase will have different goals.
The new treatment or technique must meet the objectives of each phase before moving to the next.
To ensure reliable results, it is imperative that each study must be conducted rigorously and tested to avoid any bias or error in collection or data interpretation.
CLINICAL TRIAL Phase I
– To check that the drug experienced in detail in animals is well tolerated by humans.
– To evaluate the terms of administration.
– To study the side effects, according to increasing doses of treatment.
CLINICAL TRIAL Phase II
– To establish precisely the effects of the drug, according to the doses and treatment modalities established in Phase I.
– Deepening the study in Phase I with a larger number of patients.
– To evaluate the efficacy and tolerance of the new drug.
CLINICAL TRIAL Phase III
– To confirm the effectiveness of treatment demonstrated in Phase II.
– To compare the new treatment to other commonly used standard treatments.
– Award of the type of treatment by random computer draw for the objectivity of the results.
After this phase, if there are a real benefit and no risk to the patient, the new drug receives from the Ministry of Health its Marketing Authorization.
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. They are, usually, private doctors or hospitals that have, mostly, been involved in research.
The investigator physician must, in fact, justify specific skills to the domain studied. He will suggest the trial to patients meeting the criteria.
This is the process conducted by clinical research associates to ensure that all data collected during the trials, in the report forms, are accurate, complete and consistent with the source documents.
The CRAs verify, too, that included patients respond well to predefined selection criteria and all SAEs have been reported.
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