Introduction to clinical development [MBIMB305]

Learning outcomes

The student will have acquired general knowledge of the complex process of the clinical phase of drug development.

Objectives

The student will have acquired knowledge of the importance of conducting clinical trials in general (the history of clinical trials, why conduct a clinical trial, the importance of clinical trials in Evidence Based Medicine, etc.); the practical conduct of a clinical trial; the main players involved in developing and conducting a clinical trial; the key stages in conducting a clinical trial, including the importance of the clinical trial committee and the role of the clinical trial investigator. ); the practical conduct of a clinical trial; the main players involved in developing and conducting a clinical trial; the key stages in conducting a clinical trial, including the importance of the ethics committee, monitoring adverse events, etc.; the role of regulatory agencies (EMA, FDA), good clinical practice and quality assurance. In addition, students will be trained in systematic bibliographical research, to raise their awareness of this key preliminary stage in the development of a research project.

Content

•     Importance of conducting clinical trials in general (history of clinical trials, why conduct a clinical trial, importance of clinical trials in Evidence Based Medicine, etc.);
•     Practical conduct of a clinical trial;
•     Key players involved in developing and conducting a clinical trial;
•     Key stages in the conduct of a clinical trial, including the importance of the ethics committee, the monitoring of adverse events, etc. ;
•     Role of regulatory agencies (EMA, FDA);
•     Good clinical practice;
•     Quality assurance
•     Systematic bibliographical research
•     etc.

Exercises description

Where appropriate, some sessions will be followed by an exercise in the form of a quiz to ensure that you fully understand the topic covered during the course.