Participation in a trial
You would like to find out more about participating in a clinical trial? If so, please contact your doctor and discuss possible options with him / her.
Afterwards, your doctor or you personally can contact us or another study center. For this it may be necessary for you to send us a current medical report in advance. Based on your documents, we can check which of the many therapeutic trials are eligible for you. Before participating in a study, a personal interview with the investigator is required. With the investigator you will discuss the significance, implications, consequences and risks of participating in a suitable trial.
To participate in a study your written consent is required in the form of a signature. For this there will be a second appointment. Subsequently, a phase we call “screening phase” begins. Within this phase we will check if you meet the criteria to participate in the trial. Usually this includes blood sampling, ECG and a new CT and MRI. In some trials further examinations are necessary before the beginning of the treatment.
After successful completion of the “screening phase” the “therapy phase” begins. This phase differs from trial to trial. Usually, all trial-specific tests must be carried out at the trial center. In Phase I trials the participation effort is higher than it is in Phase III trials. This is mainly due to the frequent safety checks of a treatment with drugs which are used in humans for the first time. In most cases, the intervals between the regular check-ups extend during the course of the trial. To monitor the success of the therapy, CT and MRI examinations are carried out at regular intervals. In most studies with targeted drugs, whether in the form of antibodies or inhibitors, the patients receive the drugs as long as they work and are well tolerated.
Please keep in mind that the treatment with unapproved drugs takes place in form of a trial, because the effects and tolerability are not conclusively known. Therefore, no definite statement about the success of the therapy can be made in advance.
|Participation in a clinical trial|
|1. Contact your doctor|
|2. Examination of medical reports and medical findings|
|3. Personal talk for clarification with the examining doctor|
|4. Additional appointment for written consent|
|5. Screening phase, check for inclusion and exclusion criteria|
|6. Intervention/ therapy until progress of the disease or trial ending|
|7. Possibly follow up after intervention|
|8. Patients can always withdraw their consent|