Teaching Responsibility

LJMU Schools involved in Delivery:

Pharmacy & Biomolecular Sciences

Learning Methods

Lecture

Seminar

Workshop

Module Offerings

6004PHASCI-JAN-CTY

Aims

Upon completion of this module, students should be able to demonstrate an awareness and understanding of preclinical testing and management and regulation of clinical trials in the process of drug development. In addition, students should be able to discuss the challenges and ethical issues in patient recruitment and retention and the importance of publication of clinical trial data.

Learning Outcomes

1.
Describe the key processes involved in preclinical and clinical testing during drug development in accordance with GCP-ICH guidelines.
2.
Discuss the importance of preclinical and computational toxicity in drug development.
3.
Identify the challenges with respect to patient recruitment and retention in the different phases of Clinical Trials and the ethical issues of outsourcing of clinical trials.
4.
Apply and interpret essential statistical requirements when documenting and reporting clinical trials.

Module Content

Outline Syllabus:
Preclinical toxicity testing
Computational toxicity
Adverse Drug Reactions
Clinical trial documentation TMF, CRF, IB
Clinical Trial design
Patient recruitment and retention
Outsourcing of clinical trials
Ethics and Law 
GCP-ICH
Standard Operating Procedures
Statistics for Clinical Trials
Trial Closedown and Clinical Trial Data Dissemination
Module Overview:
The aim of this module is to gain an awareness and understanding of preclinical testing and management and regulation of clinical trials in the process of drug development.
Additional Information:
Emanuel EJ, Grady C, Crouch RA, Lie R, Miller F, Wendler D (Eds.): The Oxford Textbook of Clinical Research Ethics. Oxford University Press 2008.
Fisher J: Medical Research For Hire: The Political Economy of Pharmaceutical Trials. Rutgers University Press 2008.
Klitzman RL: The Ethics Police? The Struggle to Make Human Research Safe. Oxford University Press 2015.
Hawkins JS, Emanuel EJ (Eds.): Exploitation and Developing Countries: The Ethics of Clinical Research. Princeton University Press 2008.
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – Website
An Introduction to Randomized Controlled Clinical Trials. JNS Matthews. London: Arnold, 2000
Principles of Biochemical Toxicology, Fourth Edition. John A . Timbrell. CRC Press 2008

Assessments

Essay

Centralised Exam