More information about Phase 1 trials

Phase 1 studies at the Netherlands Cancer Institute are carried out by the Clinical Pharmacology Department in collaboration with the Clinical Research Unit (CRU).

If you and your physician have discussed the option to participate in a Phase 1 trial, and you are considering going through with it, you can expect the following steps:

• Your physician will refer you to a physician at the clinical pharmacology department, who can discuss the goal of the Phase 1 trial with you, and who can inform you what your participation will look like. This physician will help you find an eligible trial.
• Once you know which trial you can participate in, your physician will be able to provide information about the goal of the trial, the potential side effects, the planning, and the treatment expectations during a consultation. You will also receive a folder with this information to take home to review at a later time.
• Then you will have a consultation with a CRU nurse. They can discuss the exact process of the trial, like when you will have to come to the hospital, and how often, and what the treatment consists of. The nurse can answer any questions you may have.
• Have all your questions been answered and would you like to participate? Then you will have to sign an informed consent form in which you declare that you understand the consequences of your participation.
• Before the start of your treatment, you may have to come in for examinations (screenings) to determine whether you meet the inclusion criteria. This may involve an ECG, additional scan, blood test, or examination by an ophthalmologist or dermatologist. The specific factors that we are looking for, will depend on the trial.
• Then you will meet with a clinical nurse specialist at the CRU for an examination to find out whether you are in sufficient physical shape to qualify for participation. There will be time to ask any remaining questions you may have.
• One or two days before the start of the trial, you will be informed about your participation; your clinical nurse specialist will contact you by phone.
• Up to a few days after your screening, you can start your treatment. The treatment will be delivered according to a trial protocol that outlines what is going to happen, and at which time. Usually, treatment will start with a hospital admission of one (or more) nights at the CRU. We will expect you at the department at 8 o'clock in the morning.
• Depending on the protocol, you will have to come to the hospital regularly for a checkup with your clinical nurse specialist and to receive your treatment, or for just a checkup or blood draw. Your clinical nurse specialist will be your contact person during this time.