Clinical Epidemiology and Biostatistics Course 2018

Designing Clinical Research
Clinical Epidemiology and Biostatistics Course 2018


(KUI: 7024: 4 credit units)
Time: Thursday – Saturday
(From January 11 – 27, 2018)

Course Director: Prof. Siswanto Agus Wilopo, M.D., M.Sc., Sc.D..
Professor, Department of Biostatistics, Epidemiology and Population Health


The goal of clinical research is to draw inferences from findings in the study about the nature of the universe around it. This course is an introduction to the process of clinical research, defined broadly as patient-oriented, translational, epidemiological, comparative effectiveness, behavioral, outcomes, or health services research (i.e., any research that has individual human beings or groups of human beings as its unit of observation). Students are exposed to overarching concepts and essential vocabulary for designing and interpreting clinical research for their clinical practice and/or achieving higher degree in health science. This is primarily accomplished by instructing students in the creation of a research protocol that is intended to address a relevant research question in their specific area of interest. Lectures will cover the following areas: –clinical and statistical design of phase I, II and III trials; –observational study including prognostic study, — evaluation of diagnostic tests and screening program; –the protocol review and IRB process, ethical issue and informed consent, and –data collection, trial monitoring and statistical analysis for clinical research.

The goals for this course are for participants to:

  • acquire skills for designing, interpreting, and statistical analysis for clinical research;
  • produce a complete clinical research protocol, including background, sampling, sample size estimation, measurements, plan for data analysis, inform consent; and
  • help their colleagues to develop clinical research protocols.


At the end of the course the student should be able to:

  • Formulate clinical research questions which can be answered by the researcher
  • Design clinical research project to answer questions proposed
  • Describe an overview of basic biostatistic and epidemiological methods involved in conducting clinical research
  • Prepare sampling method and sample size estimation according to study design and statistical analysis selected/planned
  • Formulate statistical techniques to answer study proposed
  • Describe the principle involved in the ethical, legal, and regulatory issues in clinical human subject research, including the role of Institutional Review Boards (IRBs).
  • Demonstrate on how to write a protocol of clinical research for dissertation or thesis


a. Possession of at least an undergraduate degree or enrollment in the Post Graduate Program at Faculty of Health Science, Public Health and Nutrition, Universitas Gadjah Mada, Yogyakarta.

b. Submit an idea for a research question in clinical research that has been discussed with an experienced investigator or the thesis or Dissertation Advisor (Application form and Template Short protocol can be downloaded from: from http:/ Please submit this form during your registration or email it to Student who did not submit this form will not be enrolled in the class. We do not expect you to submit final protocol rather than draft for maximum 5 pages (excluding references).

c. Proficiency with word processing software, biomedical literature searching with PubMed, Science Direct, Scopus, Wiley online library and reference management software (i.e.: Endnote)

d. Students who have not had experiences for word processing software, biomedical literature searching, and reference management software will be given a special training by Staffs of Center for Reproductive Health a week before the course date. Please register for this special training to email address above.


To apply for this course, please fill out and submit the application below. This course is a free for registered student who has been approved by his/her study program. Course materials (photocopy of reading materials) are not free and it is responsibility of student to pay. The deadline for application is January 9, 2018.

Complete syllabus and tentative time table can be download, here.


List of reading materials can be downloaded here. This list will be updated time to time according to the student’s need. All printed materials will be distributed in the class.

Meeting Place will be Room 106 Gedung IKM Lantai 1

ADVANCE STATISTICAL COURSE – Reggression Analisys and Modelling for Health Data

Course will Started in 17-18 and 22-23 December 2010
Instructor: Dr. Siswanto Agus Wilopo, SU, M.Sc. ScD
Description Course:
This is a there credit course intended for graduate students pursuing degrees in a Master or Doctorate Degree in Health Science. Topics covered will include linear, logistic, poison, and Cox regression. Estimation, interpretation, and diagnostic approaches will discussed
Course Objectives:
Upon successful completion of the course, the student will be able to:
– Apply, interpret and diagnose linear regression models
– Apply, interpret and diagnose logistic, poison and Cox regression on models
Topic of Course:

  • Introduction to regression: simple linear regresion (SLR)
  • Linear model properties; software tutorial
  • Inferences and assumption checking in SLR
  • SLR Diagnostics
  • Inferences in SLR
  • Diagnostics (continued);  correlation intro to
  • Multiple regression
  • Hypothesis testing in MLR
  • MLR
  • Forms for predictors interactions
  • F-test and Anova; F-tests and Coefficients of Determination
  • Multicollinearity
  • MLR Model Building
  • MLR diaagnostics
  • MLR example
  • Introduction to logistics regression; link functions
  • Likelihood ratio tests and deviance
  • Goodness of fit, information criteria
  • ROC analysis
  • Logistic regression for case control studies
  • Logistic regression example
  • Ordinal Logistic regression
  • Introduction to Survival analysis
  • Survival analysis
  • Cox regression
  • Cox regression example
  • Poisson regression
  • Random effects models

Participants  should  register  by  email  or  phone  in the following address:
Ms. Utami Dwiastuti/Ms. Antini Kurniawati
Maternal  and  Child  Health  –  Reproductive  Health Division, Department of Public Health
Faculty of Medicine, Gadjah Mada University
IKM Building 1st Floor, Room 110
Phone/Fax (0274)565076 or 548156


Dr. Siswanto Agus Wilopo,SU,MSc,ScD
Department of Public Health
This course offers continuing education units (CEU’s). For those successfully completing the course (generally this means marks of B or better on the homework), is equal to 3 credits and a certificate will be issued by  Postgraduate Program of Public Health, Faculty of Medicine, Gadjah Mada University, upon request
Aim of Course:
To learn analyze data from studies in which individuals are  followed  up  until  a  particular  event  occurs,  e.g. death, cure, relapse, making use of follow-up data also for those who do not experience the event.
This  course  describes  the  various  methods  used  for modeling and evaluating survival data, also called time-to-event data or  time  failure analysis. To    field of engineering,  where  it  is  typically  referred  to  as  reliability analysis.
To use a convenient statistical package (e.g., STATA, R, or S+) to analyze survival analysis data. It  is desirable    their own  clean data  sets  for  the exercise during the workshop.
Learning Objectives:
At the end of this course students will be able to:

  • identify when it is appropriate to use survival analysis methods
  • define censoring, survivor function and hazard function
  • calculate a life table for a follow-up study with individuals grouped in time intervals according to how long they survived, allowing for censoring
  • calculate a life table for individual survival times using the product-limit (Kaplan-Meier) method
  • identify when it is appropriate to use the logrank method and Cox’s proportional hazards model
  • write computer programs in STATA or R to obtain life tables, perform logrank tests and fit Cox proportional hazards models, and interpret output from these programs
  • adjust for qualitative covariates in a logrank test
  • check the proportional hazards assumption and describe what to do if it does not hold
  • use tables or computer programs to determine the required sample size for a follow-up study that will use survival analysis

Course Program:
Module 1:
An overview of survival analysis methods with many examples
Key terms: survival and hazard functions
Goals of a survival analysis
Data layout for the computer
Data layout for theory
Descriptive statistics for survival analysis- the hazard ratio
Graphing survival data- Kaplan Meier
Module 2:
Introduction to the Cox Proportional Hazards (PH) model- computer example
Model definition and features
Maximum likelihood estimation for the Cox PH model
Computing the hazard ratio in the Cox PH model
The PH assumption
Adjusted survival curves
Checking the proportional hazard assumption
Module 3:
Introduction to the Stratified Cox procedure
The no-interaction Stratified Cox model
The Stratified Cox model that allows for interaction
Definition and examples of time-dependent covariates
Module 4:
Definition and features of the extended Cox model
Stanford Heart Transplant Study Example
Addicts Dataset Example
The likelihood functions for the extended Cox model.
Sample size estimation for a follow-up study that will
use survival analysis
The first batch of the course will be started in
3 December 2010 for two weeks. Participants
are required to be present in the class for 2 days
at every week (Friday and Saturday).
Next  course will be announce later
Participants  should  register  by  email  or  phone  in the following address:
Ms. Utami Dwiastuti/Ms. Antini Kurniawati
Maternal  and  Child  Health  –  Reproductive  Health Division, Department of Public Health
Faculty of Medicine, Gadjah Mada University
IKM Building 1st Floor, Room 110
Phone/Fax (0274)565076 or 548156
16 hours class per week (two days class)
COURSE Fee: Rp. 500.000
Download leaflet pdf