Explore frequently asked questions around the entire clinical trials process, including how to participate, and what you can expect to happen during and after taking part.
Galapagos is a biotechnology company dedicated to developing transformational medicines for more years of life and quality of life.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, clinical trials are regulated with built-in safeguards to protect participants. A clinical trial follows a carefully controlled protocol. The protocol is approved by the government and ethics committee before they start. The design of clinical trials is often conducted with patients and health authorities.
As a clinical trial progresses, researchers report the results of the clinical trial at scientific meetings, to medical journals and to various health authorities. Individual participants’ names will remain secret and will not be mentioned in these reports. Galapagos is committed to following the strictest ethical and legal procedures throughout the development of a new treatment.
Requirements, also called “inclusion criteria”, can refer to lab values, the type and stage of a medical condition, previous treatment history, and other medical conditions.
“Inclusion criteria” are the requirements a person must have to take part in a clinical trial. By allowing only certain participants in a clinical trial, researchers can be sure that the results are caused by the treatment and not by other factors.
“Exclusion criteria” are requirements that prevent a person from taking part in a clinical trial and are developed in line with the clinical trial criteria. These are set for several reasons, including to ensure the results are occurring as a result of the treatment and not due to other factors, or for ethical reasons to protect people whose condition may be made worse if they took part in a clinical trial (for example pregnant women and children are often excluded).
If you are interested in searching for a suitable clinical trial, you can speak to your doctor or search for a clinical trial. If you find a suitable clinical trial, you should speak to your doctor, who will be able to provide further guidance.
Every clinical trial is different in terms of its length (it could be several months or even years) and what takes place during the clinical trial. During a clinical trial, people undergo treatments and tests according to a “protocol”.
Some clinical trials compare a new treatment to a standard one that is already available (standard of care). Other clinical trials compare a treatment to a “placebo”. Some clinical trials just look at a treatment without any comparisons.
Everything is planned very carefully to keep those taking part as safe as possible. The key details of a specific clinical trial would be explained to you by your doctor or clinical trial coordinator before agreeing to take part, and you can leave a clinical trial at any point.
Because the treatment is still in the research phase, not all information related to side effects may be known. Therefore, people taking part in a clinical trial will be monitored throughout to check on their health and look for any side effects. If it is thought to not be safe the clinical trial will be stopped. It is possible to leave a clinical trial at any point.
A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of people taking part will be given an experimental drug or treatment, while the control group is given either a standard treatment for the medical condition (standard of care) or something called a placebo.
A placebo looks like a treatment but does not have any real treatment. In clinical trials, new treatments are often compared with placebos. This helps make sure that any effects are actually caused by the treatment being studied.
Blinded clinical trials are designed to prevent people taking part in the clinical trial and the research team from influencing the clinical trial results and to allow for the most scientifically accurate conclusions.
Clinical trials can take place in clinical trial sites such as doctors’ offices, medical centers, community hospitals and clinics. You will normally go to the clinical trial site closest to you. There may be a few or many clinical trial sites participating in the clinical trial, depending on the clinical trial phase. Each location has a research team, which includes doctors, nurses and other healthcare professionals.
Yes. Most clinical trials provide treatments related to the medical condition but do not provide extended or complete primary healthcare. In addition, your doctor can work directly with the research team to discuss things such as any other treatments you’re taking. You will be monitored closely throughout the clinical trial process and many people see their regular doctor more frequently than normal when taking part in a clinical trial.
Clinical trials are extremely important for developing treatments which are effective and safe. By joining a clinical trial, it’s possible to get access to a treatment that is not available to others because it is not yet approved by health authorities and, therefore, not available for use.
Those taking part in a clinical trial are closely monitored throughout the process to check on their health. Through joining a clinical trial, you may help others with the same medical condition in the future.
The company that organizes the clinical trial is likely to pay for costs associated with the clinical trial. You may be able to expense travel costs however, this will be different for each clinical trial. The clinical trial coordinator will be able to provide more guidance.