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Validation of surrogate outcomes in randomized controlled trials in patients with chronic obstructive pulmonary disease.
Taiwan (FMS-Taiwan) - National Cheng Kung University, Tainan
Department of Public Health, College of Medicine
Type of Research Project
- Clinical Project without Laboratory work
What is the background of the project?
It is common in randomized controlled trials to use surrogate outcomes, i.e., the short-term outcomes that substitute for long term clinical outcomes. It is hence important to evaluate the validity of these surrogate outcomes. The current project will use the data from the National Emphysema Treatment Trial that was done on patients with chronic obstructive pulmonary disease, COPD. We will examine the association of surrogate outcomes (ex. lung function and exercise capacity) and mortality, and the validity of these surrogate outcomes according to Prentice criteria.
What is the aim of the project?
To evaluate the validity of surrogate outcomes in patients with COPD.
What techniques and methods are used?
The student will use data from a randomized controlled trial that was done on COPD patients in the US. The student will perform data analysis using standardized statistical software, such as SAS. SAS is known as "Statistical Analysis System" previously and it is a statistical software suite developed by SAS Institute for advanced analytics, multivariate analysis, business intelligence, criminal investigation, data management, and predictive analytics. The student will need to review several statistical methods papers to perform the data analysis.
What is the role of the student?
- The student will observe the practical experiments but will be highly involved in the analysis of the results
- The tasks of the student will be performed on his/her own
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The student will first get familiar with the dataset of the National Emphysema Treatment Trial. The student will need to review key papers in validation of surrogate outcomes in randomized controlled trials. The student will then learn the coding of SAS in order to perform data analysis. If the student can finish the analysis, the student is encouraged to write up the report and try to publish the report in a scientific journal or present their work in a scientific conference.
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
The tutor (professor) will meet with the student for at least one hour per week. The student will be asked to read medical literature assigned and discuss with the tutor (professor). The student is welcome to attend seminar in our department.
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a poster - The student will prepare a presentation - The student will prepare a scientific report - The student will prepare an abstract - The student’s name will be mentioned in a future publication - The student will have the opportunity to present the results together with the supervisor at a conference
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
Biostatistics and epidemiology basic courses
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students - Graduated students (less than 6 months) - Dental medicine students (IADS members)
- Yu; T.; Hsu; Y. J.; Fain; K. M.; Boyd; C. M.; Holbrook; J. T.; & Puhan; M. A. (2015). Use of surrogate outcomes in US FDA drug approvals; 2003–2012: a survey. BMJ open; 5(11); e007960.
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