WHICH PATIENTS ARE ELIGIBLE FOR CLINICAL TRIALS?
In clinical trials, there are usually four phases (phase 1 – 4) each with its own goal. Early Drug Development Center (EDDC), focuses on phase 1 and phase 2 clinical trials. Phase 1 trials will look into how the human body responds to the drug. For instance, looking into metabolism, administration or correct dosage. In phase 2, two things are investigated: if the treatment works for a specific group of patients. The best balance between safety of and response to the treatment is also determined.
A wide range of patients are eligible for clinical trials, but specific requirements are dependent on the study. These requirements or inclusion criteria need to be met before you can refer your patient for a clinical trial. They are usually described in detail in the protocol for the specific trial. However, in general, the inclusion criteria are:
What are the inclusion criteria for patients in general?
A wide range of patients are eligible for clinical trials, but specific requirements are dependent on the study. These requirements or inclusion criteria need to be met before you can refer your patient for a clinical trial. They are usually described in detail in the protocol for the specific trial. However, in general, the inclusion criteria are:
1. Type of tumor
Phase 1 trials are usually open to various types of tumors.
2. Measurable disease
Having a measurable disease, which means it can be scanned and accurately measured by an experienced radiologist.
3. Standard therapy
Having received standard therapy.
4. ECOG/WHO
ECOG / WHO performance score is 0 or 1. This scale is a prognostic factor and determines a patient’s ability for therapy toleration. These numbers stand for:
5. Renal and organ
Having an adequate renal and organ function.
6. Biopsy of the tumor or metastasis
You can find more information about the referral process for early clinical research here. You can also directly refer a patient for a clinical trial through this form.