It all starts with a single goal: to promote better quality of life and longevity for the population. To this end, the pharmaceutical industry develops new drugs to treat various types of illness.
After laboratory tests that prove the safety of the test substance, it is ready to be administered to human beings. Research centers seek out patients, led by the principal investigator, under the guidance of the industry or the CRO contracted to conduct the study.
Stages
The first step is to check the effects of the substance and the tolerance at which it is considered effective - from the highest to the lowest tolerance. Side effects and how long the substance lasts in the body are also assessed.
In this phase, the aim is to demonstrate the effectiveness of the active ingredient, how it behaves and to determine its safety.
The aim is to establish indications, dose, route of administration, side effects, contraindications and interaction with the use of other drugs.
Once approved for sale, the substance actually becomes a product and is still monitored
Safety and well-being
In clinical research, the patient always comes first. The entire study is governed by the ICH/GCP Principles (Good Clinical Practice of the International Council for Harmonization) and the ethics committees of the regulatory agencies. At all times, the patient is accompanied by the doctor, who is available 24 hours a day in case of any reaction or adverse event that may occur.
When something goes wrong, the doctor is informed and immediately alerts the industry and the ORPC. Both generate a report to all the research centers in the world participating in the same study.
Who funds clinical research?
The study is funded by the research sponsor - usually the pharmaceutical industry. There is a commitment to pay for the patients' travel and food costs, as they need to attend several appointments throughout the treatment. For the medical team, the fees for care and procedures are also covered by the sponsor.
At the end of the research, if the studies are successful, the drug is registered by the regulatory bodies. The industry becomes the owner and begins production for commercialization.
How do I take part in a clinical trial?
Research centers can fill out a free registration form on the Clinical Research Centers website and thus be among the sponsor's options.