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30.08.2018

Question 5: Who decides whether you can participate in a clinical study?

A. The company that develops the drug
B. The organization acting as intermediary
C. The research doctor
D. The candidate

 

 

Answer 5: C & D

An intermediary, such as C-Lys is only involved in the preselection of candidates. It is the study doctor who decides whether you can participate in a clinical study and it is finally you who decides whether you will actually participate or not.
 

30.08.2018

Question 4: Which compensation do you get when participating in a clinical study?

A. Everyone always gets a full financial compensation
B. Only patients usually receive full financial compensation (study phases II and III)
C. Only healthy volunteers usually get a full financial compensation (study phase I)
D. It is prohibited by law that participants should receive full financial compensation

 

 

Answer 4: C

Healthy volunteers who participate (phase I studies), usually get a financial compensation. However, it is legally forbidden that patients (phase II and III studies) should receive any financial compensation. In some cases they are entitled to a fee for parking and travel expenses.
 

30.08.2018

Question 3: What is a placebo?

A. The existing drug, to which we want to compare a new drug
B. An element that is administered, without having any medical effect on the body
C. The new drug from which we want to compare the effect with an existing drug for the same disease

 

 

Answer 3: B

A placebo is an element that doesn’t contain any active substances. A placebo is used when the control group receives no treatment in a clinical study. In most clinical studies, it is important that neither the study doctor, nor the researcher, nor the patient knows whether he / she will receive a placebo or not.
 

30.08.2018

Question 2: What is the control group?

A. The group of patients which is not treated with the new drug. They get either a placebo or the existing drug, so that their effectiveness can be compared with the effectiveness of the new drug.
B. The group of patients which is not treated with the new drug. They only get a placebo, so that the effect of the new drug can be examined.
C. A group of patients that will also get the new drug after the study is closed, to control the results of the study.
 

 

Answer 2: A

The control group is the group that will not get the new treatment (this is not necessarily the same as receiving a placebo). That should be the only significant difference between the control group and the study group (which follows the new treatment). Thus, in theory, the observed effect in the study group can only be due to the effect of the new drug and not to accidental or spontaneous changes.
 

30.08.2018

Question 1: Who can participate in a clinical study?

A. Only young, healthy volunteers from the male sex
B. Only young, healthy volunteers from both male and female sex
C. All healthy volunteers
D. Patients at an early stage
E. All patients

 

 

Answer 1: C and E

Both healthy volunteers (male or female) as patients may participate in clinical studies. Healthy volunteers are important for phase I studies evaluating the safety of the new drug that is being examined. In further phases of the clinical study, patients are needed to assess the efficacy and safety.
 

01.03.2016

C-Lys Platform goes online!

C-Lys is an independent website developped by the Belgian company Akcelis. Akcelis supports pharmaceutical companies and academic hospitals in their search for volunteers for clinical studies.

"We are passionate about biomedical research and want to contribute in different ways. On the C-Lys platform we provide explanation about clinical studies and we give you an overview about the ongoing clinical studies for which candidates are being sought. We act as intermediary to find suitable participants for both ongoing clinical studies as for future clinical studies."

Founders Barbara D'haene and Nathalie Niclaus