The analysis of efficacy and safety are the two most important issues when it comes to clinical trials. They are conducted to discover and confirm a drug or therapy’s clinical and pharmacological effects. They are also responsible for identifying side effects and the absorption and metabolism of medicinal substances.
Why are clinical trials conducted?
As already mentioned, clinical trials aim to check the effectiveness and safety of new therapies. Each method of treatment and medicine must be thoroughly tested before being allowed to be widely used. Despite the tremendous advances in medicine in recent years, there is still no cure for many chronic diseases. These diseases are the main focus of doctors and scientists from around the world. People who want to take part in clinical trials are being searched for. The study group must be diverse. This allows for a better assessment of, e.g., side effects.
Monitoring of clinical trials
The Principles of Good Clinical Practice define how to conduct and monitor a clinical trial. It is an essential part of conducting them correctly. Clinical research courses online or in-class allow learning about the rules and regulations that must be followed. A necessary element of such a course, apart from theoretical knowledge, is contact with scientists. Only in this way can you really see what this type of work is all about, and what problems you have to face every day.
Phases of clinical trials
Each clinical trial must be divided into at least 3 phases. This is to minimize the risk and select the target group for the trial in the best possible way. These include:
– Phase 1 – during this phase, it is assessed whether the tested medical product is safe. In case of treatment schemes or vaccines, healthy people participate in this phase. Usually, it is several dozen people. When examining drugs for incurable diseases, there must be people in the group who have a given condition and volunteer to be part of the trial. The first trial phase takes place in research centers or pharmaceutical companies. It allows determining the dosage of drugs.
– Phase 2 – during this stage of the trial, it is assessed whether the drug or method of treatment works in the indicated group of patients and what the risks are. It is conducted on many more people. Usually, it is several hundred volunteers. In most cases, these should be patients suffering from the disease in question. The double-blind method is used to maintain the reliability of the clinical trial.
– Phase 3 – even several thousand participants may participate in the last phase of the clinical trial. This phase aims to test the short- and long-term efficacy and safety of treatment. It may take up to several years. The so-called double-blind method is also used. If during the trial it turns out that the drug or therapy is effective, the process of registration and introduction to wide application begins.