Clinical Trial Statistics

Clinical trial research plays an important role in medical research. Our biostatisticians and staffs span all manner of technologies with extensive experience to assist clinical investigators conducting researches at NHRI and Taiwan Cooperative Oncology Group (TCOG). We also assist industries in statistical design, data management, quality control, data monitoring, and statistical analysis as well as publication for promoting clinical development of drugs, medical devices, and clinical procedures. We provide comprehensive quality systems consulting services in essential aspects of clinical research and statistical support in cancer, neuropsychiatric research, infectious disease, geriatric studies, and cardiovascular disease. The research direction in clinical trial statistics research includes

Clinical research involves investigating proposed medical treatments, assessing the relative benefits of competing therapies, and establishing optimal treatment combinations. The field of statistics is applied to clinical research for providing formal accounting for sources of variability in patients’ responses to treatment. The use of statistics allows the clinical researcher to form reasonable and accurate inferences from collected information and to make better decisions in the presence of uncertainty.

To establish peripherals for biotechnology and promoting healthcare science, Institute of Population Health Sciences has offered data management and statistical support for clinical trials in cancer, neuropsychiatric research, infectious disease, geriatric studies, and cardiovascular disease. Statistical support including statistical design of the study, development of data collection forms and manuals of procedures, all aspects of data management with emphasis on adherence to protocol and quality of data, generation of monitoring reports, statistical analysis of results, and preparation of statistical and scientific reports and publications are offered for NHRI initiated clinical research.


We have achieved the following works in cancer clinical trials, neuropsychiatric research, infectious disease, geriatric studies, and cardiovascular disease.

Clinical trials in cancer

  • Wang Z, Seow WJ, Shiraishi K, Hsiung, CA, Matsuo K, Liu J, Chen K, Yamji T, Yang Y, Chang IS, Wu C, …, Hsiao CF, et al. Meta-analysis of genome-wide association studies identifies multiple lung cancer susceptibility loci in never-smoking Asian women. Human Molecular Genetics. 2016 Jan 4;25(3):620-629.
  • Chie WC, Blazeby JM, Hsiao CF, Chiu HC, Poon RT, Mikoshiba N, Al-Kadhim G, Heaton N, Calara J, Collins P, Caddick K, Costantini A, Vilgrain V, Chiang C, Group EOTRC Quality of Life. Differences in health-related quality of life between European and Asian patients with hepatocellular carcinoma. Asia Pacific Journal of Clinical Nutrition. 2016 Apr 1. In Press
  • Chiang NJ*, Hsu C*, Chen JS*, Tsou HH, Shen YY, Chao Y, Chen MH, Yeh TS, Shan YS, Huang SF, Chen LT. Expression levels of ROS1/ALK/c-MET and therapeutic efficacy of cetuximab plus chemotherapy in advanced biliary tract cancer. Scientific Reports. Accepted. 2016.
  • Chen JS*, Hsu C*, Chiang NJ*, Tsai CS*, Tsou HH, Huang SF, Bai LY, Chang IC, Shiah HS, Ho CL, Yen CJ, Lee KD, Chiu CF, Rau KM, Yu MS, Yang Y, Hsieh RK, Chang JY, Shan YS**, Chao Y**, Chen LT**, on behalf of the Taiwan Cooperative Oncology Group. A KRAS mutation status-stratified randomized phase II trial of gemcitabine and oxaliplatin alone or in combination with cetuximab in advanced biliary tract cancer. Annals of Oncology. 2015. May;26(5):943-949.
  • Tsou HH, Yang HC, Chuang MH, Wu HY, Hsu YT, Chang WJ, Hsiao CF*, Hsu C*.Prevention of chemotherapy-induced HBV-related hepatitis flare in lymphoma patients with resolved HBV infection: cost analysis. Journal of Hepatology. April 2014 Volume 60, Issue 1, Supplement, Pages S206–S207.
  • Hsu C, Tsou HH, Lin SJ, Wang MC, Yao M, Hwang WL, Kao WY, Chiu CF, Lin SF, Lin J, Chang CS, Tien HF, Liu TW, Chen PJ, Cheng AL. Chemotherapy-induced hepatitis B reactivation in lymphoma patients with resolved HBV infection: a prospective study. Hepatology. 2014, Volume 59, Issue 6, 2092-2100, June 2014.


Clinical trials in neuropsychiatric research

  • Liu SW, Liu YL*, Hwang LL, Wang SC, Kuo HW, Wu SL, Dai YW, Liu SC, Ho IK, Chen ACH, Hsiao CF, Tsou HH*. Chemokine IP-10 is correlated with cardiac responses and status of infection with HIV and HCV in methadone maintenance patients. International Journal of Cardiology. 2015 Sep 1;194:36-38.
  • Wang SC, Tsou HH, Chung RH, Chang YS, Fang CP, Chen CH, Ho IK, Kuo HW, Liu SC, Shih YH, Wu HY, Huang BH, Lin KM, Chen ACH, Hsiao CF, Chen YT, Liu YL. The Association of Genetic Polymorphisms in the k-Opioid Receptor 1 Gene with Body Weight, Alcohol Use and Withdrawal Symptoms in Patients with Methadone Maintenance. Journal of Clinical Psychopharmacology. 2014, April; 34(2):205-211.
  • Lin HL, Hsu YT, Liu CY*, Chen CH, Hsiao MC, Liu YL, Shen WW, Hsiao CF, Liu SI, Chang LH, Tang HS, Lai HL, Lin PS, Lin KM, Tsou HH*. Comparison of escitalopram and paroxetine in the treatment of major depressive disorder. International Clinical Psychopharmacology. 2013, 28(6):339-345.
  • Kuo HW, Liu SC, Tsou HH, Liu SW, Lin KM, Lu SC, Hsiao MC, Hsiao CF, Liu CY, Chen CH, Lu ML, Shen WW, Tang HS, Liu SI, Chang LH, Wu HY, Chang YS, Yeh TK, Chen AC, Liu YL. CYP1A2 genetic polymorphisms are associated with early antidepressant escitalopram metabolism and adverse reactions. Pharmacogenomics. 2013, 14(10):1191-1201.


Clinical trials in geriatric studies

  • Chan DC, Tsou HH, Chang CB, Yang RS, Tsauo JY, Chen CY, Hsiao CF, Hsu YT, Chen CH, Chang SF, Hsiung CA*, Kuo KN*. (2016). Integrated Care for Geriatric Frailty and Sarcopenia: a Randomized Control Trial. Journal of Cachexia, Sarcopenia and Muscle. In press.
  • Chan DC, Tsou HH, Yang RS, Tsauo JY, Chen CY, Hsiung CA, Kuo KN. (2012). A Pilot Randomized Controlled Trial to Improve Geriatric Frailty. BMC Geriatrics. Sep 25; 12(1): 58.
  • Chan DC, Tsou HH, Chen CY, Chen CY. Validation of the Chinese-Canadian study of health and aging clinical frailty scale (CSHA-CFS) telephone version. Archives of Gerontology and Geriatrics, 2010; May-Jun;50(3):e74-e80.


We set up standard operation procedures (SOP) for clinical trial data flow and management, we have established the Clinical Trial Information Management System (CTIMeS) which is an electronic data capture and web-based data management system. Research areas to foster interesting statistical research in clinical trials then include adaptive design/analysis in clinical trials, bridging study, multi-regional clinical trials, non-inferiority clinical trials, and biosimilars.

Evaluations of bridging studies

  • Tsou HH*, Tsong Y, Liu JT, Dong X, Wu Y. Weighted evidence approach of bridging study. Journal of Biopharmaceutical Statistics 2012; 22(5): 952-65.
  • Tsou HH*, Chang W-J, Hwang W-S, Lai Y-H. A consistency approach for evaluation of biosimilar products. Journal of Biopharmaceutical Statistics 2013; 23(5): 1054-66.
  • Evaluation of multi-regional clinical trials
  • Liu JT, Tsou HH*, Gordon Lan KK,…, Hsiao CF*. Assessing the consistency of the treatment effect under the discrete random effects model in multiregional clinical trials. Statistics in Medicine 2016.
  • Tsou HH*, Lan KKG, Liu JT, Hsiao CF. Alternative Random-Effects Model: the Discrete Random Effects Model (DREM) — Assessing Benefit and Consistency of Treatment Effect under DREM. In: Chen JH and Que H (Eds.), Multi-Regional Clinical Trials for Simultaneous Global New Drug Development, Chapman & Hall/CRC 2016, Taylor & Francis, New York, NY, USA. Print ISBN: 978-1-4987-0146-4.
  • Tsou HH*, Tsong Y, Chang WJ, Dong X, Hsiao CF. Design and analysis issues of multiregional clinical trials with different regional primary endpoints. Journal of Biopharmaceutical Statistics 2012; 22(5): 1051-9.
  • Tsou HH, James Hung HM, Chen YM, Huang WS, Chang WJ, Hsiao CF*. Establishing consistency across all regions in a multi-regional clinical trial. Pharmaceutical Statistics 2012; 11(4): 295-9.


Non-inferiority clinical trials

  • Liu JT, Tzeng C-S, Tsou HH*. Establishing non-inferiority of a new treatment in a three-arm trial: apply a step-down hierarchical model in a papulopustular acne study and an oral prophylactic antibiotics study. International Journal of Statistics in Medical Research 2014; 3(1): 11.


Evaluating biosimilarity of biological products.

  • Tsou HH*. Evaluation of Biosimilars-Statistical Perspectives. Journal of the Chinese Statistical Association. 2015;53(1): 11-22.
  • Tsou HH*, Chang W-J, Hwang W-S, Lai Y-H. A consistency approach for evaluation of biosimilar products. Journal of Biopharmaceutical Statistics 2013; 23(5): 1054-66.