Trials

A trial represents a scientific investigation which is required before a drug or a therapy design is admitted.

This investigation has to prove that a drug or a therapy design is efficient and uncritical for the patients and also brings advantages in comparison with other drugs or designs. Therefore, clinical trials are essential to reach progress in cancer care and develop the best and most effective therapy strategies for patients.

“How does a trial come up?”

Before a trial can be started, severe scientific and legal requirements have to be fulfilled. Normally the trial protocol is compiled by different “experts” of the respective specialty on basis of latest scientific data, then examined by an independent ethics committee and finally presented to the federal authority for release. Furthermore, it has to be concluded a patients’ insurance that will pay in case of damages which are attributable to the trial therapy.

“What are the advantages of a participation in a trial?”

Patients in clinical trials are under “special care”; usually they receive newest therapy designs whose validation and application are only possible within the frame of the scientific trial. At the worldwide largest cancer congress of the American Society of Clinical Oncology (ASCO) held 2000 in New Orleans, the Austrian work group around A. Gnant could show that patients with breast cancer within clinical trials in comparison with patients outside of trials lived clearly longer because they had a more intensive care and surveillance.

The chemotherapy of ovarian cancer should anyway be effected preferably within clinical trials to improve the data situation for the patients and further optimize progresses already reached.

“Are there reasons which do not allow a participation in a trial?”

Frequently different trials are available for the different situations (e. g. first or second treatment).

In order to ensure safety for the patient, so-called inclusion and exclusion criteria are stated in the trial protocol. Before the trial starts, the attending physician controls how far the criteria are true. By doing this, certain accompanying illnesses (e. g. active convulsion disorder or severe kidney damage) can exclude a participation in a certain trial.

The goal of all performed NOGGO-trials is to publish their results. In addition, if possible phase III trials should be performed as Intergroup trials to randomize the required number of patients in a short time.

Translational research shall be integrated in the trial protocols.