CECOG AND ITS CLINICAL TRIALS IN INTERNATIONAL CONTEXT
The field of academic research in clinical oncology is characterized
by the performance of large, randomized, well controlled clinical trials
which test for an amelioration of current treatments by the use of innovative
drugs and/or techniques, new drug combinations and/or
new treatment schedules.
Statistical requirements necessitate the inclusion of large
numbers of patients who are supposed to share a similar profile of
prognostic factors as well as disease characteristics
As a consequence, studies originating from single or even many
institutions can recruit only a limited number of patients over a long
enrollment period providing unrepresentative results with low potential
to answer relevant questions and at a limited pace of progress.
In addition, quality of treatment and treatment standards differ considerably between centers and countries. Based on these considerations, cooperative multicenter groups have been set up in clinical oncology in order to enroll huge numbers of patients within a reasonable time and simultaneously establish and implement common control criteria of quality assurance and patient care. Such cooperative study groups in oncology have operated not only in the United States where they include the Eastern Cooperative Oncology Group (ECOG), the South Western Oncology Group (SWOG), the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the Cancer and Leukemia Group B (CALGB), but also in Europe where they are undisputedly being headed by the European Organization for the Research and Treatment of Cancer (EORTC), and have also been represented by other initiatives for a long time.
Following these examples, the Central European Cooperative Oncology Group (CECOG) was formed, which, apart from its aim to conduct high quality, internationally compatible clinical trials in oncology, focuses on specific, yet in many aspects similar circumstances in countries of Central- and Southeastern Europe and beyond.
Controlled trials in malignant diseases
Optimized cytotoxic treatment has often resulted in an increase
in remissions, but only rarely in a prolongation of survival.
Moreover, quality of life has been only inadequately weighed against
the necessity of cytotoxic treatment for sustaining organ function.
Finally, new therapeutic concepts including such various aspects
on maintenance of remission, new polychemotherapy protocols with
recently developed cytotoxic drugs of proven efficacy in monotherapy
trials, and, finally, biologically active preparations have
recently arisen.
CECOG's aim is to participate and excel in these
innovations by means of the development of innovative treatment protocols and
thereby define new treatment standards.
CECOG - Interactions
Interaction with pharmaceutical industry:
Within the frame of clinical trials, CECOG cooperates with
the biggest pharmaceutical companies active in the field of oncology.
Thus, a close cooperation for the conduct of clinical research
protocols on a variety of malignant disorders has been established
with Amgen, Aventis-Sanofi, Bristol-Myers
Squibb, Eli Lilly Company, Merck, Novartis, Pharmacia-Upjohn and
Roche which have all cooperated in the design, the establishment
of quality control measures as well as interaction with local CECOG representatives
and, finally, will be closely involved in the conduct of trials.
CRO:
CECOG is devoted to high quality standards and is constantly collaborating with well-established Contract Research Organizations in order to perform monitoring and data management of each clinical trial.