Design, Conduction and Evaluation of a Clinical Trial

 

This course provides an insight in the area of clinical trials with patients, with more detailed coverage of trial, analysis and interpretation of phase IIb-IV studies from the point of view of clinical research, industry and government.

The course is organized in collaboration with the Clinical Pharmacology and TCC (Trial Coordination Centre). The course is based on interactive exercises and will be presented by means of capita selecta and practicals within the framework of students’ own to-bedesigned clinical trial.

The course lecturers will review important information regarding the practical issues in the design of clinical trials and protocol development, as well as broader issues related to the initiation and conduct of clinical trials and the analyses and interpretation of clinical trial data.

Students will learn: 

• Basic statistical concepts, such as descriptive statistics, hypothesis testing, estimation, confidence intervals, different statistical tests, etc.. Biomedical applications are discussed for each topic.
• Fundamentals of clinical trial design. Topics include definition of hypotheses, measures of effectiveness, sample size, randomization, interim analysis, safety considerations and issues in statistical analysis.
• Ethical and regulatory issues in the design conduct and reporting of research will be examined. Topics include GCP, informed consent, patient information, and institutional review boards.
• Coordinating clinical trials – issues will be addressed regarding coordinating a clinical trial. It covers organizational aspects, forms design and collection, quality control and other operational methods to improve the quality of data.  

 

Study load

3 ECTS credit points

 

Calendar

Probably October 2012

 

Registration

Ms. M.H. (Maaike) Bansema (m.h.bansema@umcg.nl)

Phone: +31 50 363 8409

 

Coordinator

prof. H. (Hans) Hillege

ms. J.A. (Janneke) Bergsma, PhD

 

Additional information

Before participation in this course, you must have completed either the 'Good Research Practice; GCP/GLP' course or 'BROK' course.