Basics of pre-clinical and clinical research

For the Basics of Preclinical Research submodule, a series of lectures by internal and external speakers, accompanied by small group exercises in class, on the following topics:

• Drug development – Setting the scene : Overview of drug development cycle

• From invention to clinical trials – Don’t overlook key preclinical research : Introduction to drug discovery and preclinical development

• Bioassay techniques for drug discovery and development : disease-relevant in vitro and in vivo models

• Experimental design and data analysis for in vitro research and animal experimentation

• How to design preclinical studies for personalized medicine and (regenerative) cell therapy (2h): Ex vivo culture of organoids

• Systems biology to identify disease-relevant gene networks : integrative methods for multi-omics data

• Intellectual property (IP) strategies : European Patent Convention, Biotechnology Directive 98/44/EC

For the Basics of Clinical Research sub-module, a series of lectures by internal and external speakers, accompanied by small group exercises in class, on the following topics:

1. The Ethical Environment: Origins and Current Reality

2. Different Types of Clinical Research

3. Basics of Clinical & Epidemiological Study Design

4. Statistical Basis for Clinical & Epi Research

5. Epidemiological Modeling

6. Regulatory Oversight and Influence

7. Safety and Adverse Events

8. Biobanks & Data Base Analyses

9. The Actual Conduct of Clinical Trials

• Understand the challenges of the (evolving) drug development cycle, in particular the pre-clinical challenges
• Outline the evolution from chemistry-based to target-based drug discovery
• Understand target identification and validation
• Recognise drug screening and design
• Understand preclinical development
• Understand the movement from small molecules to biologics, advanced therapies and medical devices

For the Basics of Clinical Research sub-module, the student should:

1. Develop a basic appreciation of the main motivations for conducting clinical trials, and be able to provide examples of each

2. Understand the distinctions between and characteristics of different phases of clinical research (Phase I, II, IIIa/IIIb, IV), and the inherent advantages, limitations, and challenges of each

3. Be able to articulate the major elements of a clinical trial protocol, and the underlying rationale for inclusion of each

4. Appreciate and understand the different clinical trial designs to assess efficacy/effectiveness/impact on diseases, and be able to defend the choice of study design for specific research questions, diseases and populations. Describe some of the common failings of unsuccessful clinical trials.

5. Comprehend the ethical environment around clinical trial conduct, including the historical evolution of current informed consent and GCP, how ICH and Declarations of Helsinki fit in, the role of ethical review, and where ethical ambiguities and debates still exist.

6. Be able to discuss when and how interactions with regulatory authorities and other public health agencies can shape clinical trial design, and key relevant regulatory guidance

Cours co-requis

Cours ayant celui-ci comme co-requis

I. Theoretical and practical lectures by Coordinator and guest lecturers, each designed to be interactive with students, with time for discussions.

II. Each topic will include small group work involving case studies, role playing, and often culminating in oral presentations

III. Background readings, both theoretical and with specific case examples

Support(s) de cours

• Université virtuelle

Contacts

For Pre-clinical Research sub-module: hstevens@i3health.eu

For Clinical Research sub-module: William.hausdorff@ulb.be

Campus

Erasme

Méthode(s) d'évaluation

• Examen écrit
• Présentation orale
• Travail de groupe
• Autre

Examen écrit

Présentation orale

Travail de groupe

Autre

For Preclinical Research submodule:

1. Short quizzes (mainly on key concepts, terminologies) 25%

2. In class participation and oral presentations based on small group case studies 25%

3. Rationale for and design of pre-clinical trial section within written proposal of a Translational Research Program prepared for “Translational Research in Selected Disease Areas” BIME G5506 course 50%

For Clinical Research submodule:

1. Short quizzes (mainly on key concepts, terminologies) 5%

2. In class participation and oral presentations based on small group case studies 25%

3. Short essay reviewing a brief clinical trial protocol 20%

4. Rationale for and design of clinical trial section within written proposal of a Translational Research Program prepared for “Translational Research in Selected Disease Areas” BIME G5506 course 50%

Construction de la note (en ce compris, la pondération des notes partielles)

The grade will be 50% from each submodule (Basics of Pre-Clinical and Basics of Clinical Research). A failure for one part of the course (either Pre-clinical or Clinical Research) cannot be compensated by the other part. 

For both the Basics of Pre-clinical AND the Basics of Clinical Research, the oral presentations (2) will be assessed based on the clarity and comprehensiveness of the presentation, and ability to respond to questions. In the Basics of Clinical Research section, the short essay (3) will need to provide a succinct, critical analysis of the key features of the protocol provided, especially where elements are incorrect or missing.
Both the pre-clinical, as well as the clinical trial section of the Translational Research Program proposal (4) will be evaluated on whether the main key elements of a (pre-)clinical trial protocol are clearly presented and adequately justified.

Within each of the pre-clinical research AND clinical research submodules, the students will have one specific evaluation that will count for 50 % of the total points. The other 50% will be derived from the evaluation of the clinical or pre-clinical research sections, respectively, of the final research project prepared by the students for the Teaching Unit: Translational Medicine in Selected Disease areas BIMEG-5506.

The final score for the module BIME G-5512 will be the arithmetic mean of the pre-clinical research AND clinical research submodules.

Langue(s) d'évaluation

• anglais