Clinical Trials [MSBMM103]

Learning outcomes

Student will know the historical background of the current rules and regulations, through a couple of cases that led to the creation of FDA, EMA and Pharmacovigilance;

Student will have gained insights in the complex process of the clinical phase of drug development as well as medical devices development by pharmaceutical and biotechnological companies and will understand the registration of new drugs and its challenges;

Student will understand the evolving importance of contract research organizations (CRO) and the impact of outsourcing in health related research;

Student will have knowledge on the different actors involved in this process, and are capable of describing their specific roles such as CTA, CRA, RSU, sponsor, CRO, research team, investigator, Quality Assurance, Quality Management, Ethics Committee and Regulatory Agencies;  

Student will become capable of using own knowledge in practice, during an internship in a clinical research environment .

Objectives

Student will have gained the necessary knowledge and skills, when complemented by the practical experience of an internship and Master's thesis, to move on to CTA, Start up specialist or CRA position within a clinical research setting (academic and/or industry)

Content

Building upon the course on Preclinical Drug Development (MSBM M102), the student will get an overview of the entire process of Clinical Drug Development. Using the "standard" drug development as an example, some particular other settings (pediatric clinical trials, medical device studies) are also discussed. The current rules and regulations are explained and put into a historical perspective.

The course will teach how the different actors are involved in clinical drug research, about the respective roles and the way they interact between one another. Through some practical exercises and visits to phase 1, CRO and pharmaceutical companies, student will have better insights how medication is distributed, stored and administered to subjects, how the coordination in Clinical Trials Centers happens and what the different source documents look like.

The course will discuss some ethical questions, new trends in Clinical Development, innovative ways to recruit subjects in Clinical trials, adaptive design, concept of Lean and the latest trends in Clinical research.  At the end we tackle the Belgian Clinical Trials Law, as well as the new European Regulation on Clinical trials that will come into force by end of 2017

Exercises description

Students will receive some exercises to prepare and present. Thorough understanding on how to write an Informed Consent Form based upon a real life protocol. Identify the important criteria that defines a correct ICF. Furthermore students will receive a case study to prepare as well with regard to a recent phase 1 accident, which occurred in a first in human study.