Medical laboratories are constantly working on new drugs that will enable more effective therapy or combating previously incurable diseases. Due to the need to meet stringent standards, before any medication is allowed on the market, it must go through the phases of clinical research.
Clinical research – basic information
Before entering the market, each drug undergoes a series of strictly defined and monitored clinical research that determines its effectiveness, dosage, and possible side effects. These procedures apply to both unregistered substances and products already in use, thanks to which it is possible to test, among other things, a new formula or method of taking them. Drug evaluation consists of three phases, which gradually cover an increasing number of respondents and allow to study all aspects of taking the product – from the rate of absorption and interaction with other substances to the refinement of dosing.
Who is participating in the clinical research?
The proper conduct of the research requires the presence of qualified personnel, consisting of doctors, nurses, pharmacists, and other adequately trained medical personnel. The international GCP (Good Clinical Practice) guidelines assume that the procedure must be attended by people who have completed clinical research training. This allows to take responsibility for the course of the study, meet the regulatory conditions, and provide documentation that meets the standards of the study sponsor, an independent ethics committee, and an evaluation committee.
In addition to medical workers, the research requires volunteers, who can be divided into three groups. The first group usually includes healthy people who take the drug to assess its safety and basic properties. The second group of volunteers is people with a specific medical condition or disease to assess the effectiveness of the drug. Usually, these types of tests are carried out in parallel with the control group, i.e., patients who use the standard drug in the case of a given therapy or a placebo.
Three phases of a clinical research
1st Phase – aimed at assessing the safety of the drug and determining the appropriate dose. The subjects are a group of several dozen to one hundred usually healthy people who help determine the absorption, metabolism, toxicity, excretion, and drug interaction with food and other medications. When a drug for an incurable disease is tested, the group of respondents may include people who suffer from this disease.
2nd Phase – takes place with the participation of several hundred people suffering from a specific disease. This step tests the drug’s effectiveness, evaluates its short-term safety and determines the optimal dose that provides maximum efficacy while minimizing side effects. Typically, at this stage, a control group is also used as well as placebo measures in double-blind testing – that is, one where both the person giving the drug and the person taking the drug do not know whether they are dealing with a substitute.
3rd Phase – is conducted with the participation of a large number of volunteers from around the world. This phase of the study is designed to confirm the dosing, evaluate the efficacy of therapy in a typical patient, and verify medium to long-term safety. If the drug offers better results among patients compared to the pharmaceutical scheme used, it is then allowed to apply for its registration and introduction to the market.