ESBiC: Structure and Organization

Extensive and comprehensive research in the treatment of infectious and malignant diseases is often beyond the means of single institutions both in basic and clinical research and can best be accomplished through multidisciplinary, multinational efforts in way of a joint venture of clinical and basic groups. With the intent to serve as an European forum and to harmonize the development and evaluation of antiinfective agents, anticancer drugs and immunomodulators, the European Society for Biomodulation and Chemotherapy (ESBiC) was founded in 1991 at the 17th International Congress of Chemotherapy (ICC) in Berlin and is registered in Bratislava, Slovakia.

Aims

The aims of the ESBiC are:

The ultimate goal of the ESBiC is to improve the standard of the treatment of infectious diseases, cancer therapy and clinical use of biomodulators in Europe through the testing of drugs and/or new therapeutic regimens. Research is accomplished mainly through the execution of large, prospective, randomized, multicenter, clinical trials. In this way the ESBiC facilitates the passage of experimental discoveries into state-of-the-art treatment.

Structure and Organization

To focus efforts achieving the objectives mentioned above, the ESBiC is organized into cooperative groups which emphasize complementing interests of the membership. To date, the following six groups are established: Pharmacology; Medical Microbiology; Surgical Infectious Diseases; Urinary Tract Infections; Infections in the Immunocompromised Host and Biomodulation and Chemotherapy of Malignant Disorders. Phase III trials, as well as quality of life data and health economics evaluation, are carried out by these cooperative groups. Their participation in ESBiC activities allows them to carry out research that would be difficult, or impossible, to realize on a purely national level. The data management and statistical analyses of the studies conducted by these groups are performed by the ESBiC data center, located in Munich, Germany.

At the administrative level, ESBiC consists of a board, and several councilors. The board is the legislative body. Policies, proposals, activities are ratified by the board. The board delegates specific functions to committees or appointed persons such as the councilors whose decisions are reported to, and ratified by the board. The cooperative groups initiate new activities and formulate proposals before submitting them to the ESBiC board.

Activities of the ESBiC

In its efforts to meet the objectives mentioned above, the ESBiC will work towards the following:

ESBiC Data Center

The ESBiC data center is the nucleus of the clinical research effort provided by the various cooperative groups. It provides a unique, well established resource of expertise for the conduct and coordination of research activities related to infectious and malignant diseases on a truly European level.
Created in 1991, the objectives of the data center are to provide data management, computer, statistical and medical expertise to the ESBiC cooperative groups at a central, and therefore economical, site. It is concerned with all aspects of phase III clinical trials including specialty services such as quality of life and health economics evaluation, from their design to the publication of the final results. It also offers expertise on the legal aspects of research, procedures and compliance with good clinical practice and insurance cover.

The clinical trials conducted by the ESBiC are coordinated and supervised by many of the most widely respected European infectious disease and cancer specialists. However, the design and preparation of such trials, the collection of patient data, their statistical analysis and the publication of results requires a data center composed of highly qualified scientific personnel.

The ESBiC data center staff comprises: a director; a medical supervisor; biostatisticians; data managers; an information systems project leader and computer analyst; and secretaries.

Conclusions

Through the conduct of large scale, multinational trials, ESBiC studies produce reliable results which can have a rapid influence on the treatment of infectious and malignant diseases, not only in Europe, but also on a worldwide basis. Finally, through the distribution of knowledge and expertise acquired in its research activities the ESBiC is contributing to improve therapy of infectious and malignant diseases as well as fulfilling a broader educational role in all aspects of antiinfective and antineoplastic chemotherapy.

Niels-Alexander von Rosenstiel, M.D. in Antiinfective Drugs and Chemotherapy, 1995, p. III-IV, Vol. 13, No. 2


ESBiC Datacenter Munich, 1999