How does clinical research work?
Clinical research is about finding new methods to treat a certain disease. At the Early Drug Development Center (EDDC), we aim to develop and test new drugs for cancer patients. We are looking into optimal dosages, side effects or adverse events and the effect of medication on tumors.
Different phases of clinical research
Developing and testing a new drug is organized in different phases. It all starts with laboratory studies, followed by animal studies. After these steps, the new treatment is tested on a small group of patients in the first phase of clinical research. In the second phase, we look into the effect that the medication has on the tumor.
In the third phase, we look into how the new treatment compares to existing methods. The fourth and final phase of clinical research is meant to study long term effects, benefits and side effects of the new treatment. A full description of the different phases is provided below.
At the EDDC, we support and guide patients through early clinical trials. This means that only phase 1 and 2 clinical studies are performed. In this early clinical research process, we believe in creating a trusting environment to give patients the support and care they need.
“The trusting relationship we create with patients during the clinical trial period is unique.”
Marjolein van Mil, advanced practice nurse and point of contact for phase 1 patients
Phase 1
In this phase, the best route of administration is determined. This means that different ways for administering the medication are tested. For instance, by injecting or orally taking the medication. The optimal dosage is also determined. This must be in balance with side effects the drug might have. After this stage, it should be clear what a safe dosage is and how the medication is handled by the body.
Phase 2
After completing phase 1, it is important to determine how effective the drug is for treating a specific type of cancer. Phase 2 studies are about how the body, and the tumor, react to the medication. Are the cancer cells reacting to the drug? Does it affect tumor growth or are cells actually destroyed?
Phase 3
In the third phase, the effect of the new drug is compared with standard treatment methods. The new treatment method should work properly and be safe. After completing the three phases of clinical research, the medication is registered and is allowed to come onto the market.
Phase 4
The last phase is a long lasting phase, where the drug is tested on a longer term basis, after it is released onto the market. Long term effects, benefits and side effects of the medication are studied in this phase.
How does early clinical research work at EDDC?
As we are part of the Antoni van Leeuwenhoek (AVL), we have the required experience when it comes to performing clinical research and patient care. It is important to note that the
The EDDC is entirely focused on phase 1 and 2 clinical research.
If you would like to participate in a clinical study, you should discuss it with your doctor first.
Referral process and intake
If your doctor thinks you are eligible for a clinical trial, he or she can refer you to a specialist at AVL who is part of the EDDC team. This specialized doctor will talk to you about the goal of the study and what the requirements for participation are. Together, we will look into which studies might be suitable for you.
After determining the study, the details will be discussed. The doctor will give you more information about the study, the planning, possible side effects and outcomes. You will receive this information on paper so you can read it at home. There will be an informational meeting with a nurse to discuss further details about the study. For instance, when it will take place, how often you are required to come to the hospital and what the treatment exactly entails. In this meeting, all of your questions will be answered.
After getting all information about the clinical study and agreeing to take part in the study, you need to sign an informed consent. With this, you declare that you are aware of the consequences of participating. After this step, the screening for the study is performed to determine if you meet all the criteria for participation. Screening could include an extra scan, blood examination, a visit to an eye doctor or dermatologist. The type of screening assessments that need to be done, depends on the study.
Right before the start of the trial
There is another appointment with a specialized nurse to determine if your physical condition, and other important aspects, are meeting the requirements of the study. One or two days before the start of the trial you can confirm that you are participating via telephone.
At the start of the trials
The treatment will start a few days after the screening process, depending on the study protocol requirements. For the first administration, you are usually expected to be there at 8 A.M and stay over for one or several nights. During the study, you will regularly need to come back to the hospital for assessments and to check how you are doing. Would you like to know more about the requirements for joining a clinical trial? You can find more information about who can join a clinical trial here.