Why are clinical trials necessary?
Before a new pharmaceutical or a therapeutic concept can be approved in the European Union, scientific analyses must be performed. After a new active substance or a new procedure has been tested in the laboratory, so-called clinical trials follow. The aim of clinical trials is to prove that a pharmaceutical or a therapeutic concept is effective and safe for the patients. Furthermore, it should be proven that this new pharmaceutical or therapeutic concept is superior to previously available pharmaceuticals or concepts and can therefore become a standard in the clinical routine. This means that clinical trials are necessary to advance the medical progress, especially in cancer medicine, with the help of new discoveries.
Patients’ safety during a clinical trial
The fundament of each clinical trial is the trial protocol, which is designed by experts on the basis of the latest research results. An independent ethics committee reviews the trial protocol for its ethical and moral suitability. Among other things the trial protocol contains a list stating who is eligible or ineligible for trial participation (inclusion and exclusion criteria). Concomitant diseases and additional medication taken are part of these inclusion and exclusion criteria which determine if a patient is suitable for participating in the trial. Besides, a patient insurance is effected which bears all costs in the event of damage that is attributed to the new pharmaceutical or therapeutic concept. So, before a clinical trial can be conducted in the EU, strict scientific and legal requirements in relation to patients’ safety must be met.
Your rights as a patient
Part of the rights and obligations of trial participants is that participation can be terminated at any time and without adverse consequences to their further medical treatment.
Furthermore all patient-related data may only be stored and processed in an anonymised form. If the patient wishes to make use of a different, additional treatment, this will only be permitted if approved by the trial investigator (study doctor).