Galapagos is a biotechnology company that develops treatments for a series of medical conditions, with a focus on inflammatory and fibrotic diseases. Our purpose is to improve medicine, science and patients’ quality of life.
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, clinical research is regulated with built-in safeguards to protect participants. The trial follows a carefully controlled protocol, a study plan that details what researchers will do in the trial. 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 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 “eligibility criteria”, can refer to age, gender, the type and stage of a disease, previous treatment, and other medical conditions.
“Inclusion criteria” are the requirements a person must have to take part in a trial. By allowing only certain participants in a trial, researchers can be sure that the results are caused by the treatment and not other factors.
“Exclusion criteria” are requirements that prevent a person from taking part in a trial and are developed in line with the study criteria. These are set for a number of reasons including to ensure the results are occurring as a result of the treatment and not other factors, or for ethical reasons to protect people whose condition may be made worse if they took part in a trial (for example pregnant women and children are often excluded).
If you are interested in searching for a suitable trial, you can speak to your doctor or search for a Galapagos clinical trial. This site includes all Phase 2 to 4 Galapagos clinical trials and you will find the most important requirements to enter the trial clearly displayed.
If you find a suitable clinical trial, you should then 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 trial. During a clinical trial, people undergo treatments and tests according to a “protocol”. A protocol describes what will be done in the trial and how.
Some trials compare a new treatment to a standard one that is already available. Other trials compare a treatment to a “placebo”. A placebo looks like a treatment but does not have any real treatment. Some 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 trial would be explained to you by your doctor or researchers before agreeing to take part, and you can leave a clinical trial at any point.
Because the treatment is still in the trial 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 illness 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 studies are designed to prevent people taking part in the trial and the research team from influencing the trial results and to allow for the most scientifically accurate conclusions. In single-blind studies, the participant does not know what treatment they are given but the research team will know. In a double-blind study, neither the participant nor the research staff know which treatment is given to each set of participants. If medically necessary; however, it is always possible to find out which treatment the patient in a clinical trial is taking.
Clinical trials can take place in doctors’ offices, medical centers, community hospitals and clinics. You will normally go to the closest center to you. They may be being carried out in one place or in hundreds of places at the same time. 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 in developing treatments. 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 monitored extremely carefully 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 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 trial. The clinical trial coordinator will be able to provide more guidance.