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In order to safeguard the patient and, as far as possible, to obtain good and reliable clinical data from clinical trials, certain legal, ethical and scientific requirements need to be fulfilled. These are prescribed in the international guidelines of good clinical practice, i.e. ICH-GCP: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – Consolidated Guideline E6: Good Clinical Practice).  The legal framework for the conduct of clinical trials in Germany is regulated by the German Drug Law.

The implementation of the ICH-GCP guidelines in Germany also has a legislative character. Moreover, the regulation of patient safety in clinical studies is outlined in detail in the Declaration of Helsinki. In that Declaration, the World Medical Association defines the ethical principles for research on humans. Clinical trials offered by CIO meet the requirements set out by the ICH-GCP, Declaration of Helsinki and the German Drug Law.

A trial’s objective, number of treated patients, data analysis and importantly the treatment plan, are described in the study protocol. All clinicians who treat patients as part of a clinical trial must follow the study protocol. Prior to the commencement of a clinical study, the protocol must be submitted to an ethics committee. Here, independent experts examine whether there is any increased risk for trial participants and assess the risk-benefit ratio of the study.

The responsible ethics bodies for CIO are the Ethic Committee of the University Hospital Köln and the Ethics Committee of the regional Medical Association (Nordrhein). A patient is only allowed to take part in a clinical trial after having read the relevant patient information, discussed it with a medical practitioner and signed an informed consent form. The patient information also advises the patient that he/she can withdraw from a clinical trial without giving a reason. If such a decision is taken, this will not disadvantage the patient in any way and all further treatment at CIO will be provided at the highest standard. All participants of a clinical trial are covered by a volunteers’ trial insurance which covers all study associated harms. In addition, each trial is registered with statutory regulatory bodies such as the Regional Council (Regierungspräsidium (in Köln Amtsapothekerin)), the Federal Office (Bundesoberbehörden, dem Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)) and the Paul-Ehrlich-Institut (PEI).

All personnel who have access to study related personal patient data are bound by the German data protection laws. It is also important to realise that only non-person-identifiable (anonymous) data is being used in the scientific analysis and publication of a clinical trial.

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