Everyone can be confronted with the need for a medicine. Yet, it is not so obvious that effective and safe medicines are available. To have so, extensive studies are required. This we call drug research.
In the clinical phases of drug research, research is started on patients such as patients with Alzheimer’s or diabetes. Here researchers investigate whether the medicament is effective against the disease and which doses are most suitable.
Only when all information is known, a pharmaceutical company can register a medicinal substance as a medicine. Your local government assesses whether a new medicine can be allowed in its region and under which conditions doctors can prescribe it.
Conduct of a clinical study with a new medicine
Before a patient can participate in a study with a new drug, the responsible physician will conduct an investigation on his general health and check whether the patient is eligible for the study.
From the start of intake of the new medicine, extensive medical examinations are carried out at regular intervals to determine whether the new medicine is safe and effective.
Depending on the design of the study, several study days up till months and even years are recorded in which the patient is extensively examined by a team of doctors and specialised nurses.
Rules and guidelines for a clinical study with a new medicine
A clinical trial with a new medicine should always be performed according to strict national and international rules and guidelines. Therefore, for each clinical study seperately, a binding advise from a Central Ethics Committee is required before any start up.
The studies that take place at the Anima Research Center are always submitted for approval to one of the Central Ethical Committees of the Flemish universities.
Such a committee, consisting of highly specialized doctors, independently assesses whether the proposed study may or may not continue and under what conditions.
To do this, they check whether:
- we have built up our clinical research well and meaningfully
- our clinical trial does not contain too many risks for the participants
- we give the right information to our participants
- our participants voluntarily agree to participate
In other words, they represent the rights and obligations of the participating patient.
However, the committee does not decide in your place whether you participate. They do not know your specific situation. Whether you participate, you choose yourself and this in consultation with your treating physician.
The protocol of a clinical study with a new medicine
For each clinical study, a detailed scenario, the so-called protocol, is drawn up. This is to determine unambiguously how a study should be carried out and how the data are obtained in a scientifically reliable way. The protocol thus contains all steps of the investigation and all conditions for participation and testing.
Audits and inspections
National and international authorities check whether we strictly comply with the applicable rules and guidelines. For our center, these include the Federal Agency for Medicines and Health Products (FAMHP), the European Medicines Agency (EMEA) and the Food and Drug Administration of the United States (FDA).
These authorities carry out the required audits on a regular basis to guarantee the safety of the participating patients and the integrity of the studies carried out.
All personal and medical data from the patients participating in the studies are stored in our center in code form. As a result, the identity of the participating patient remains secret for all other parties involved, such as the pharmaceutical company.