National Institute of Cancer Research

Taiwan Cooperative Oncology Group, TCOG

Introduction

Aims

Taiwan Cooperative Oncology Group is the first organization in Taiwan to conduct multi-center clinical trials for cancer treatment. It can utilize the resources of patients effectively, ensure the safety and ethics of clinical trials, establish therapies through a strict monitoring system for data gathering and patient-follow-up. By these, the integration of diagnostic technology and consensus of treatment for cancer in Taiwan are possible. The aims of TCOG are:

To promote high quality clinical research.
To facilitate multi-center oncology trials.
To improve cancer treatment and care.
To develop new modalities of treatment, e.g. new drugs, immunotherapy, differentiation therapy, antiangiogenesis and gene therapy.
To set up the guideline for diagnosis, prevention and treatment of cancer.

Background

Cancer has become the leading cause of death in Taiwan since 1982. Approximately 75 percent to 80 percent of cancer patients will succumb to their illness no matter how sophisticated the management provided. Several reasons are considered to explain why the cancer survival is unacceptably low in Taiwan:

Most cancer diagnosis was made at advanced stage.
Poor cooperation of patients for treatment.
Common types of cancer in Taiwan are apt to have intrinsic or acquired drug resistance.
Suboptimal and divergent management of cancer treatment between individual oncologists and leading medical centers.
Lack of adequate number (or critical mass) of qualified oncologists.

Therefore, training, education and reorganization of the oncologists to form a cooperative team for clinical research have become the critical steps to reduce cancer death.

Taking the Eastern Cooperative Oncology Group (ECOG) of the United States as an example, the Taiwan Cooperative Oncology Group (TCOG), established in 1989, is a multi-institutional cancer clinical trial organization.

Established Accomplishments

At present, TCOG has established Scientific Advisory Committee, Board Committee, Executive Committee, 16 Disease Committees, 4 Quality Monitoring Committees and 4 Modality Committees (The reformed structure of TCOG is showed as following). All individual committees are actively engaged in work such as the formulation of consensus statement on the diagnosis, treatment and prevention of specific cancer, writing-up the research protocols for clinical trials, and enrollment of patients into ongoing trials. Total number of the affiliated hospitals, island-wide, is now 24. TCOG's member hospitals have now served more than 90% of cancer patients diagnosed in Taiwan.

This working group is assisted by the Central Operation Center, which helps collecting information and implementing a database system from the member hospitals in the TCOG. The Operation Center is responsible for the registration, quality control and the coordination of clinical trials. We also allocate our research nurses in the TCOG member hospitals for the participation in the research projects. They are responsible for case selection, registration and therapeutic follow-up of the TCOG research projects, which are being done in the member hospitals. In order to upgrade the professional skill of clinical research nurses and provide them with the newest information of clinical trials, TCOG has begun serial training programs for them. Clinical oncologists, statisticians and nursing specialists are invited to give lectures or group seminars every three months. This continuing education program for nurses began from May 1997. TO assure high quality of data collection and compliance with the guidelines of GCP in conducting TCOG trials, the Audit Committee has conducted yearly audit to each member hospital. The recommendations made by the committee after each audit were well respected and followed by individual hospital.

The Clinical Trial Statistical Center is responsible for the design, monitoring, quality control, corrections and analysis of the clinical trial. Continuous progress for computerizing, the data flow has been made by the efforts of the Statistical Center. Using the HP workstation and SAS (Strategic Application Software), CRIMS (Clinical Research Information Management System) has been developed recently. Quality control of the data, inquiry and checking, query letters, and form submission schedule can be performed automatically. The center now is continuing operation under the Division of Biostatistics and Bioinformatics, NHRI, from Sep. 1, 1997.

The TCOG annual meeting began from 1997. Through this meeting, we gather members of each committee, researchers and scholars from the medical community of Taiwan and the abroad as well, to share experiences and learn from each other.

Future Direction

The goals of TCOG in the near future are:

Joining the international phase II and III trials to upgrade TCOG to be recognized as a qualified international study group.
Conducting more multi-modality phase III trials to improve cancer treatment, especially for the most common and unique cancers in Taiwan, e.g. hepatoma, nasopharyngeal carcinoma, cervical cancer and gastric cancer.
Developing experimental trials, such as gene therapy, immunotherapy or biological therapy, antiangiogenesis and differentiation therapy.
Establishing TCOG as the key organization for cancer drug approval through phase I, II and III trials, especially for the local generic drugs, to help and facilitate the R&D of the local pharmaceutical industry.
Publishing the consensus of standard treatment and prevention of common cancers in Taiwan.