By being part of the patient registry, you will be notified about new clinical trials in your area.
A clinical trial is a research study conducted with patients to evaluate whether a new treatment is safe (safety) and whether it works (efficacy). Clinical trials are performed to test the efficacy of drugs but also non-drug treatments such as radiotherapy or surgery and combinations of different treatments.
When researchers think that they have found a promising treatment they do not immediately treat patients with it. If it is a brand new treatment, they will first test it in the laboratory, usually on tumor cells. If results in the laboratory are encouraging, they will test the treatment on animals. These studies are highly regulated to avoid unethical tests on animals. If results of the tests on animals are encouraging, researchers will set up, together with doctors, the first step of the experimentation of the new treatment on humans.
This first step in humans is called a phase I clinical trial. Phase II and phase III clinical trials will follow if results are encouraging during the previous step. Thus, the risk for participants is higher in phase I than in phase II, and risks of a phase II trial will be higher than in phase III.
Sometimes, the treatment tested is not new, but the way it is given, the dosage or the combination with other treatments differ. It may also be a treatment already used for one type of condition. Before using it for another type of condition, however, a new study has to be done to see whether the treatment is safe and works for the new type of condition.
Participants have access to a promising treatment which is not available elsewhere The new treatment may have a higher efficacy than the standard treatment Participants will be watched carefully by health professionals according to a protocol *The clinical trial is an experiment and its results will be helpful for all. It will either allow other patients to benefit from a new and useful treatment or avoid researchers to continue their research on a useless or harmful treatment. The results will also help researchers to understand a disease better.
What are the main possible risks of participating in clinical trials?
The new treatment may not have any added value The new treatment may have some side-effects that can range from minor and reversible side-effects to life-threatening side-effects. Some side-effects can also appear weeks, months or even years later and include damages to important organs such as heart or kidney or the development of a second condition or disease In phase III clinical trials you usually do not know if you receive the new treatment or not.
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question. Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.