Drug Discovery and Clinical Trials for Molecular Pathology MED5489
- Academic Session: 2022-23
- School: School of Medicine Dentistry and Nursing
- Credits: 20
- Level: Level 5 (SCQF level 11)
- Typically Offered: Semester 1
- Available to Visiting Students: Yes
- Available to Erasmus Students: No
- Taught Wholly by Distance Learning: Yes
Pathologists are ideally skilled for determining patient and sample eligibility and evaluating patients' response in clinical trials. Clinical scientists are equipped with expert knowledge and experiences in molecular diagnosis that are essential in the recent trials that aim for precision medicine. Therefore it is not surprising that there is an increased demand for pathologists and clinical scientists who are trained in molecular pathology to play an integral role in design, undertaking and evaluation of clinical trials. This course is designed to facilitate the acquisition of minimum essential knowledge required to confidently participate in clinical trials, as well as to foster future-proof leadership in improvement of trial strategies that maximise the likelihood of patient's response and benefit.
Online delivery of core taught materials (lectures, videos/quizzes etc) supported by weekly tutorials.
Requirements of Entry
Written work in the format of a research proposal or proposal of a clinical trial (approx. 3000-4000 words) (100%)
The course aims to provide students with a critical understanding of the various stages involved in a pre-clinical drug discovery process, its methods and interpretation of results, as well as challenges and limitations in its pipeline, including aspects from health economics. The course also aims to provide the essential knowledge in the design of the optimum clinical trials for patients' response and benefit, along with up-to-date information of regulatory frameworks, and enable students to critically evaluate the clinical trial data. The knowledge gained should allow students to more effectively contribute and communicate within the clinical trial teams and to facilitate leading the active roles.
Intended Learning Outcomes of Course
By the end of this course students will be able to:
1. Critically discuss the main phases and decision points of the pre-clinical drug discovery pipeline.
2. Critically evaluate the methods and the results of target validation, lead identification and optimisation, and in vivo efficacy testing.
3. Critically discuss current issues and problems related to the drug discovery and development pipeline, including those from health economic perspective.
4. Critically discuss the main phases of clinical trials and the package of preclinical and clinical information which is required and desirable for the optimum trial design.
5. Critically discuss the regulatory framework for clinical trials of investigative medicinal products.
6. Critically evaluate the clinical trial data, including those in primary publications and systematic reviews.
7. Critically discuss the integral roles of pathologists and clinical scientists in design, undertaking and evaluation of clinical trials.
Minimum Requirement for Award of Credits
Students must submit at least 75% by weight of the components (including examinations) of the course's summative assessment.