CLINICAL DEVELOPMENT AND THERAPEUTICS - 2017/8

Module code: PHMM021

Module provider

School of Biosciences and Medicine

Module Leader

TRINDER S Dr (Biosc & Med)

Number of Credits

15

ECTS Credits

7.5

Framework

FHEQ Level 7

JACs code

B200

Module cap (Maximum number of students)

N/A

Module Availability

Crosses academic years

Overall student workload

Assessment pattern

Assessment type Unit of assessment Weighting
Coursework Home Assignment - Question 1 50
Coursework Home Assignment - Question 2 50

Alternative Assessment

N/A

Prerequisites / Co-requisites

None

Module overview

To provide a systematic overview and critical evaluation of the design, planning, implementation, evaluation and reporting on Phase II-IV clinical trials; and the application of the principles of clinical research to clinical trial design across therapeutic areas. The module is central to the MSc Pharmaceutical Medicine and MSc Pharmaceutical Medicine with Clinical Pharmacology.

Module aims

Systematic understanding of the design, planning, implementation, evaluation and reporting on Phase II-IV clinical trials

Critical awareness of the role of project management and planning for a clinical study, both national and trans-national

Comprehensive overview of the regulatory requirements in response to toxicological and safety data

Skills in statistics and data management: Pre-trial decisions and statistical plan specification.

Learning outcomes

Attributes Developed
Design, plan, execute, evaluate and report phase 2, 3 and 4 clinical trials KCT
Understand the role of project management and planning for the a clinical study, both national and trans-national KCPT
Critically review and act in accordance with regulatory requirements in response to toxicological and safety data KCT
Design clinical trials across a variety of therapeutic areas KCPT
Apply appropriate statistical analyses to clinical design and data management KCT

Attributes Developed

C - Cognitive/analytical

K - Subject knowledge

T - Transferable skills

P - Professional/Practical skills

Module content

Indicative content includes:


Clinical development programme planning: an integrated clinical development plan.
Project management
Design, management and interpretation of clinical trials across therapeutic areas.
Data management
Report-writing: data handling and analysis,
Principles of good clinical practice and procedures
Statistics and data management: Pre-trial decisions and statistical plan specification. Variations in biometry in populations, in disease. Risk factors, confounding variables. Type I and II errors, significance, power, paired and non-paired tests, parametric and non-parametric tests, confidence limits. Handling of rating and visual analogue scales, patient diaries and laboratory values.

Methods of Teaching / Learning

The learning and teaching strategy is designed to:


Develop advanced knowledge and critical evaluation of issues arising in clinical trials and good clinical practice and procedures
Demonstrate skills in the application of knowledge, in self-direction and originality in tackling and solving problems in line with the learning outcomes


Thus, the learning and teaching methods include:


Lectures and seminars (24 hours)
Class discussion, tutorials and syndicate exercise  (6 hours)


This is an intensive 4-day (09:00 – 17:00 each day) residential taught modules

Assessment Strategy

The assessment strategy is designed to provide students with the opportunity to demonstrate


advanced knowledge and critical evaluation of issues arising in clinical trials and in good clinical practice
skills in the application of knowledge, in self-direction and originality in tackling and solving problems in line with the learning outcomes


Thus, the summative assessment for this module consists of:


Two 2,000-word post module assignments in the form of essays, case studies and data interpretation exercise. The time line for the submission of these assignments is 10 weeks following completion of the module via the SurreyLearn module assignment submission folder.


Formative assessment include


Class discussion
Syndicate exercise


Feedbacks are provided verbally during the exercise.

Reading list

Reading list for CLINICAL DEVELOPMENT AND THERAPEUTICS : http://aspire.surrey.ac.uk/modules/phmm021

Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2017/8 academic year.