Clinical trials are used to test the effectiveness of a drug or therapy and to find out if and which side effects occur after taking the drug or performing the treatment. They are an important tool on the way to the approval of a new drug or treatment.

What is a clinical trial?

A clinical trial is a research study that examines the effectiveness of a drug, vaccine or new treatment. This ensures that a new pharmaceutical is safe and effective. In most cases, the first steps are tested by researchers in the laboratory and then in animal experiments. If these approaches are promising, further tests are performed on humans as part of clinical trials. In the course of a study, information about the therapy, the active agent, its indications, side effects or contraindications is increasingly gained. In general, clinical trials contain the following four phases.

Phase I

The first phase is conducted with a small number of participants, usually healthy volunteers. In this phase the tolerability of an agent is to be investigated. Thus, processes of conversion and degradation of the substance in the body (pharmacokinetics) as well as the occurrence and severity of possible side effects after oral administration, injection or infusion of the drug are observed and documented. If the drug is tolerated, seriously ill patients for whom no further treatment can be found can also be included in the study.

Phase II

In this phase, the effect, dosage and safety of the investigational product are to be examined. For this purpose the participants are divided into groups. In phase II, usually several hundred patients are treated over a short period of time. The effects of the substance at different dosages are observed and an attempt is made to determine the most effective and safest treatment program. Often several phase II trials are scheduled to test the drug in different patient populations and indications.

Phase III

The testing of a drug in a larger group of several thousand test persons over a longer period of time takes place in phase III of a clinical trial. During this period, the efficacy and safety of the investigational product in question is compared to other treatments or the effects of the investigational product in combination with other drugs are investigated. After phases II and III, an application for approval can be submitted to the Federal Institute for Drugs and Medical Devices (BfArM). Here, the data obtained so far are examined. If the authorities decide that the drug can be approved, it will also be available in pharmacies.

Phase IV

The clinical trials conducted after the approval of a drug are called phase IV. The aim of this phase of the trial is to gather even more information about the agent, for example how it works in comparison to other drugs or whether there are any long-term side effects. For this purpose, data are collected from large patient groups or patient subgroups, usually over a long period of time.

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Healex Site Management System (SMS): Cross-site study and site management

With the Healex Site Management System (SMS), the safe execution of a clinical trial across all phases is made possible. Current developments in Coronavirus research show how important it is to plan and organize clinical studies quickly and safely. The Healex SMS enables planning, execution and collaboration between all parties involved in clinical trials across multiple sites and is the leading communication platform for information and data exchange between investigators, researchers and sponsors. Over 6000 researchers and 350 hospitals currently use the SMS to manage clinical data with the highest data protection standards. Find out more here.

More information: Healex SMS