Hello everyone! This is Vanessa Montanari from the clinical research blog.
Today, I’m going to make a video about what clinical research is all about. I recently had my mom tell me that she looks at my posts on the internet and passes it on to some of her friends, but her friends ask her “What does clinical research know about clinical research? ?”. So clinical research is actually the testing of drugs on humans. When a pharmaceutical company has a promising molecule, the first step is to test the drug in animals. This is called pre-clinical research. So preclinical research can be done in mice, rabbits and then dogs. Often it is the animals that are used in this context. So, we look at these animals to see if the drug has an effect, whether it is effective, but also whether there are not too many undesirable effects. Then, if the molecule is still just as promising, we will do the clinical research. So, we test the drug on humans. These tests are carried out in hospitals in general, in university hospitals, and they are carried out by what are called investigating physicians. These are doctors who specialize in drug research. They are also doctors that you find in hospitals. Clinical research is done in several phases: four phases. These phases can last about ten years.
The first phase, Phase one is done on healthy people, that’s where sometimes there are people who participate iin paid tests. During this test, we will look to see if the drug does not have too many undesirable effects, because if it has too many undesirable effects, we will not continue with a product that is too toxic.
Then we’ll move on to phase two. So, phase two is testing to be able to assess the dose, but also the adverse effects on a larger number of people. These tests are done on about 100 to 200 people.
Then we have phase three. We will then evaluate the effectiveness on a large number of people, between 300 and 1,000 people, and it will be done worldwide. So, throughout the world, in several countries, we will compare the product under study with the reference drug. The one that you usually take for this disease and that you already find in a pharmacy or with a placebo. So, we use a placebo. A placebo is not a drug at all, it’s a fake drug, but in fact, we use placebos only if there is no other choice and there is no treatment to treat this disease.
In fact, after phase three, if the molecule is still interesting, the laboratory will apply for marketing authorization. If the drug is on the market at that time, we enter phase four.
Phase four is actually the pharmacovigilance phase. We are going to look at whether the treatment will affect everyone, that is to say there will be 10,000 people who could take the drug, and among those people, there are people who could develop adverse effects that we had not seen in 300 people. So that is where this phase will come in, where we will be able to study and see if we can eventually withdraw the drug from the market if it has too many effects or effects that we really did not expect or that are very embarrassing. For example, if the drug causes deaths when it’s just a fever medication, it’s a little embarrassing. That’s right, it’s even very embarrassing. So there are four phases.
What’s the role of the clinical research associate? So, the clinical research associate does quality control. He makes sure that the doctor who does the studies, who does the tests, is going to follow good clinical practice.
So, good clinical practices are reference texts that allow whole worlds, people from all over the world to practice testing in an ethical way and while respecting the patient, respecting the patient’s well-being The Clinical Research Associate (CRA ) will make sure that the doctor carries out the tests on good clinical practices and he will travel to several hospitals in France to make the necessary checks. He will check patients’ medical records, he will check at the pharmacy that the medicines have been used correctly by the pharmacist and the hospital doctor, and he will make sure that the patient’s rights are respected in clinical studies. So it’s a very important job, because it ensures that the data that will be used in the trial are reliable and that the patient is respected in the study, that’s it.
So it’s a very important job, because it ensures that the data that will be used in the trial are reliable and that the patient is respected in the study, that’s what it’s all about.
So I hope this little explanation has helped you understand what clinical research and the CRA profession is all about. If you liked this video, I thank you for liking it and for putting an I like underneath it. If you have any questions, please ask me and I will be happy to answer them.
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