SOP 01: Clinical investigations in CESAR.

CESAR Central European Society for Anticancer Drug Research – EWIV (CESAR) is an association of scientists in the area of basic sciences, preclinical oncology and clinical oncology (see also I. Preamble of the Bylaws of CESAR). CESAR is organized in specific working groups dealing with drug development and preclinical pharmacology, Phase I, phase II, and phase III study performance and clinical pharmacology thereby contributing to reach the above defined goals. Aim of the preclinical and clinical oncologic scientists is to conduct clinical trials in medical oncology, either on behalf of the study group itself or on behalf of external sponsors, like pharmaceutical companies. Such trials have to comply with current guidelines on Good Clinical Practice (GCP) to ensure the acceptability of the data to the scientific community and to drug regulatory authorities. The Note for Guidance on GCP that has been issued by ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) is applicable to clinical trials commencing after January 17, 1997 [1]. Because of convenience, these GCP guidelines are referred to as ‘ICH-GCP’ within this SOP series. The SOPs of CESAR define or address exclusively requirements for clinical activities but do not apply basic scientific and preclinical activities, that are covered by CESAR-AWO regulations. According to ICH-GCP, the sponsor of a clinical trial has to verify the suitability of each participating investigator and institution [1; section 5.6.1]. It is the aim of CESAR to shorten the lead time for the initiation of a particular clinical trial by applying and documenting appropriate procedures before granting a group membership. The selection criteria for becoming a member in a clinical working group (phase I, phase II, phase III) cover both the medical qualification and experience of the medical oncologist as well as the organization and equipment of the institution to which he/she is affiliated. A cumulative data base on the number of patients with key indications that working group members have treated will support the identification of institutions with adequate recruitment rates for a new clinical trial.