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
INTRODUCTION
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.
LEARNING OBJECTIVES
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
PREREQUISITES
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:/www.chnrl.org). Please submit this form during your registration or email it to adhi_44@yahoo.com). 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.
ENROLLMENT
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.
REQUIRED READING
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
