Investigator-Initiated Trials : Key Concepts and Best Practice [MSBMM213]

Learning outcomes

• Pre-requisites:

Clinical Trials [MSBMM103]

By the end of the course the student will:

• Understand the lifecycle of an investigator-initiated including:
  •                development of detailed project plans,
  • understanding the approvals process,
  • the importance of a statistical analysis plan, data management plan and risk based trial monitoring,
  • and knowing how to set and monitor milestones and take corrective action if applicable.
• Understand the role of a Clinical Trials Unit.
• Be able to classify a clinical research study appropriately and have an understanding of the associated regulatory framework.
• Know the general skills and knowledge required to comply with international standards of good clinical practice.
• Have an awareness of the challenges of investigator-initiated clinical trials.

Objectives

This module will focus on providing an understanding of the challenge and interest of developing investigator-initiated trials in Belgium and worldwide.

Students will learn about the practical steps involved in setting up and managing investigator-initiated clinical trials.

Content

Investigator-initiated trials are clinical trials initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups.

The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.

Although initiating investigator-initiated trial provides greater flexibility, it comes with greater responsibilities, must fulfil the same regulatory and legal requirements and must achieve the same quality than industry initiated trials.

Based on experience this module will walk you through the lifecycle of an investigator-initiated trial from design to publication and the key steps involved in their delivery.

Exercises description

Students will receive practical exercises related to investigator-initiated trial to prepare and to present.