Division of Biostatistics and Bioinformatics
Introduction | Research Projects | Achievements | Members
About Us
Founded in 1997, the Division of Biostatistics of the National Health Research Institutes was the first academic biostatistics institution in Taiwan. It's aim is the advancement of Taiwan biomedical and health research. Due to the growing importance of bioinformatics in the genomic Research at NHRI, starting from December of 2000, the Division is now the Division of Biostatistics and Bioinformatics.
Under the leadership of Dr. Chao Agnes Hsiung, the Division endeavors to advance biostatistics methodological research and theory, to assist in intramural collaborative research in statistical design and analysis, to develop and maintain the NHRI biomedical research data management system, to support biostatistics and bioinformatics related research for intramural and extramural projects, to promote information exchange and communication among biostatistical researchers in Taiwan and abroad, and to provide necessary biostatistics and bioinformatics consultation and educational training for biomedical researchers.
Mission
The mission of the Division of Biostatistics and Bioinformatics (DBB) is to apply statistical knowledge and informatics technology to promote and improve human health and welfare in Taiwan.
DBB works toward this mission by:
- Applying statistical principles on design, analysis, and state-of-the-art information management systems to advance biomedical research and raise the clinical trial standards;
- Carrying out revolutionary and high quality research on bioinformatics and statistical genetics to advance biotechnology and genomic medicine;
- Conducting high quality theoretical and methodological research on biomedical statistics and bioinformatics;
- Providing training for researchers on biostatistics and bioinformatics in Taiwan and disseminating biomedical information.
Research Projects
Clinical Trials
- Beginning Time: 1989–Present
- Investigators: Director Chao A. Hsiung, Professor Jen-Pei Liu, Dr. Chin-Yu Lin, Dr. Chin-Fu Hsiao, Dr. Jeng-Min Chiou, Dr. Yen-Feng Chiu, Dr. Ting-Hsiung Lin, Dr. Chieh-Yu Liu
- Statistical Consult: Dr. Dar-Shong Hwang
- Biostatisticians: Hui-Tzu Yu, Mei-Suei Lin, Mei-Hsing Chuang, Shu-Chuan Lai, Chao-Tung Lee, Jih-Shin Liu
- Filing and Coding: Jih-Rong Yang
- Data Entry: Shu-Chuan Hu
TCOG
TCOG is the sole group in Taiwan that conducts multi-center trials. The Statistical Center of TCOG was established at the outset when TCOG launched in 1989. The Statistical Center is now located in the Division of Biostatistics and Bioinformatics, National Health Research Institutes and in charge of both the data management and statistical support for all clinical trials conducted by TCOG.
The Statistical Center initiated the "Data Safety and Monitoring Committee" which is responsible for monitoring the safety and ethics of trials during their process. The statistical center also initiated the "Audit Committee" to ensure the data quality of the trial.
Nowadays, TCOG also conducts some other trials different from previous research. For example, the longitudinal follow-up study entitled "A multi-center survey of HPV in cervical intraepithelial neoplasia (CIN) with longitudinal follow-up of LSIL cases" has a different point of view in statistical consideration.
Besides cancer clinical trials, the Division of Biostatistics also supports other NHRI divisions and Department of Health, the Exective Yuan in conducting other clinical research and the regulation of clinical trials.
The study status of all clinical trials conducted by TCOG is listed as the following:
1.Current Studies
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T1297
- Phase III Randomized Trial Comparing Adjuvant Recombinant Interferon - α versus Conservative Treatment in Postoperative Hepatocellular Carcinoma
- Patient accrual: 267 (as of April, 2003)
- Case evaluation finished: 175
- Date activated: October 1, 1997
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T1399
- Phase III placebo-controlled chemoprevention study of oral cavity squamous cell carcinoma patients
- Patient accrual: 156 (as of April, 2003)
- Case evaluation finished: 48
- Date activated: April, 1999
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T1899
- A multi-center survey of HPV in cervical intraepithelial neoplasia (CIN) with longitudinal follow-up of LSIL cases
- Patient accrual: 1255 (as of April, 2003)
- Case evaluation finished: 556
- Date activated: August 18, 1999
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T2399
- Phase III study of post-operative adjuvant concurrent chemoradiotherapy for high-risk oral cavity squamous cell carcinoma patients
- Patient accrual: 91 (as of April, 2003)
- Case evaluation finished: 28
- Date activated: August, 1999
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T2201
- Postoperative Adjuvant Chemoradiotherapy for Patients with Stage III Adenocarcinoma of Stomach-A Phase III Randomized Clinical Trial
- Patient accrual: 14 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: April 1, 2001
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T1401
- A Randomized Study of Prophylaxis or Therapeutic Effects of Lamivudine Against Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Carrying Hepatitis B Surface Antigen and Undergoing Lymphoma Chemotherapy
- Patient accrual: 29 (as of April, 2003)
- Case evaluation finished: 12
- Date activated: October 1, 2001
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T1E01
- Adjuvant Therapy After Radical Hysterectomy for Patients Who Have Stage Ib-IIa Cervical Carcinoma With Pelvic Lymph Node Metastases
- Patient accrual: 4 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: February 1, 2002
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T1202
- Prospective phase II randomized trial of postoperative adjuvant chemotherapy in patients with high risk colon cancer
- Patient accrual: 34 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: April 1, 2002
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T3202
- Weekly gemcitabine plus high-dose 5-Fluorouracil / Leucovorin in the treatment of advanced or metastatic carcinoma of the biliary tract - a phase II clinical trial
- Patient accrual: 16 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: July 1, 2002
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T1802
- WAn open, non-comparative trial to assess the efficacy and safety of oral thalidomide (THADO) in patients with progressive metastatic hormone-refractory prostate cancer
- Patient accrual: 9 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: November 1, 2002
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T2202
- Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma with Poor General Condition
- Patient accrual: 3 (as of April, 2003)
- Case evaluation finished: 0
- Date activated: March 1, 2003
2. Proposed studies
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Nasopharyngeal Carcinoma Disease Committee
- A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
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Gynaecologic Oncology Disease Committee
- Double Blind, Randomized Multicenter Phase II Study of Thalidomide with Platinum Analogue and Paclitaxel for Advanced Epithelial Ovarian Carcinoma after Debulking Surgery
3. Terminated studies
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T1394 (Nasopharyngeal Carcinoma)
- A Phase III Study of Radiotherapy with or without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
- Patient accrual: 158
- Date activated: November 1994
- Date terminated: July 15, 1999
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T1495 (Lymphoma)
- A Comparative Study of Steroid-containing versus Steroid-free Chemotherapy for Non-Hodgkin's Lymphoma in Hepatitis B Virus Carriers.
- Patient accrual: 50
- Date terminated: May 1, 2000
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T1296 (MALToma)
- Eradication of Helicobacer pylori in the Management of Stage IE & IIE-1 Primary Low-grade B Cell Lymphoma of Mucosa-Associated Lymphoid Tissue Type of the Stomach
- Patient accrual: 41
- Date activated: March 2, 1996
- Date terminated: April 1, 1999