Article written by Ibtissam Hamimed
In the course of his or her professional career, the clinical study coordinator is required to work with different sponsors on different studies and on numerous pathologies. Employers are becoming more and more demanding when recruiting, so it is often required to have proven experience in a particular speciality such as oncology, cardiology etc.
Self-training in clinical research, a necessary evil
Versatility and autonomy are one of the skills required of a clinical study coordinator in order to best perform his/her duties and adapt to his/her work environment. Although the clinical study coordinator does not have an absolute knowledge of all the pathologies studied, his/her knowledge evolves with the experience gained during the various study protocols. To find out more about how the clinical research coordinator occupies his or her days, click here Clinical Research Coordinator.
The clinical trial coordinator’s self-training regarding these different pathologies is fundamental. He or she must first understand the pathology before looking at the study and the mechanisms of action of a molecule or therapeutic management.
When writing a study protocol, the sponsor devotes the first part to reminders about the molecule and the pathology under study. It is not uncommon for this information to be insufficient when the pathology is poorly known by the clinical trial coordinator. These searches are based on summaries of former university courses, books on medicine and epidemiology, blogs, but also and above all online medical courses. These searches are based on summaries of former university courses, medical and epidemiology books, blogs, but also, and above all, online medical courses, and are clear and concise. One should not hesitate to download different courses in order to cross-reference information and master the essentials. It is necessary to be pragmatic and to synthesize the information necessary for the good progress of the study.
Where to get information on pathologies? Methodology.
Let’s take the example of a clinical studies technician who has to work on a study involving lung cancer. The clinical studies technician will have to carry out 4 distinct searches: the respiratory mechanism, the pathology, the molecule and finally the available treatments.
First of all he will look at the respiratory system itself by reading online medical summaries such as nursing courses that remain both simple and complete, for example http://www.ifsi-ifas-lafleche.fr/medias/document/17.pdf or medical manuals. Similarly the clinical studies coordinator must find out about the pathology being treated this time by referring to online medical courses that are easily accessible in PDF format http://www.medecine.ups-tlse.fr/DCEM2/module12/Module157_MZS/157_poly_tum_poumon.pdf, association sites such as https://www.maipoumons.org/blog but also sites of various “ARC Foundation” foundations. There are in France different associations taking care of various pathologies, the following link groups together some of them https://www.france-assos-sante.org/reseau/associations-membres/, there are sometimes groups of associations. In the field of oncology some institutes and federations such as the CURIE institute and the National Federation of Cancer Centres UNICANCER set up platforms rich in useful information. The coordinator of clinical studies must then find out about the molecule in the study by referring to the first-line investigator’s brochure. Also the articles available on the websites of scientific journals such as NATURE and NCBI https://www.nature.com/subjects/cancer-immunotherapy,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6333045/. This research is essential specifically if the molecule is being tested in phase I and is being administered for the first time in humans. There are many journals that publish more or less specialized data such as: Blood, Haematologica, France Hémato ect …
The good relationship with the doctor can help the clinical studies coordinator to optimize and deepen his research by identifying for example the most frequent adverse events or the tests performed before with the same molecule in other studies. It is necessary for the clinical study coordinator to spend time researching the different treatments available on the market and the usual recommendations for the pathology being studied, in order to understand where the novelty of the treatment being tested lies. The site of the French National Authority for Health (HAS) hosts information on the usual treatment of the disease. There are also links that deal with the latest news on pathologies https://www.lequotidiendumedecin.fr/specialites/pneumologie.
Some sites constitute an encyclopedia in a particular field of intervention such as ARCAGY which treats all women’s cancers.
It is not uncommon for hospitals to offer training sessions once a month according to a predefined schedule. These training sessions are an excellent opportunity to perfect one’s knowledge and it is also an opportunity for clinical study technicians to exchange with investigators and nurses on a previously agreed theme. In clinical trials, the training courses are an effective way to reinforce one’s knowledge and master the fundamental points of the clinical trial technician’s job, GCP Good Clinical Practice is a necessary basis.
During the study, the clinical trial technician can count on the investigator to answer his questions on medical topics and help him to understand the effects of the molecule.
It is necessary to keep in mind that a clinical studies technician who masters the context related to the pathology, will better understand his study and will more easily respect the protocol.
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