CLINICAL DEVELOPMENT AND THERAPEUTICS - 2017/8
Module code: PHMM021
School of Biosciences and Medicine
TRINDER S Dr (Biosc & Med)
Number of Credits
FHEQ Level 7
Module cap (Maximum number of students)
Crosses academic years
Overall student workload
|Assessment type||Unit of assessment||Weighting|
|Coursework||Home Assignment - Question 1||50|
|Coursework||Home Assignment - Question 2||50|
Prerequisites / Co-requisites
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.
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.
|1||Design, plan, execute, evaluate and report phase 2, 3 and 4 clinical trials||KCT|
|2||Understand the role of project management and planning for the a clinical study, both national and trans-national||KCPT|
|3||Critically review and act in accordance with regulatory requirements in response to toxicological and safety data||KCT|
|4||Design clinical trials across a variety of therapeutic areas||KCPT|
|5||Apply appropriate statistical analyses to clinical design and data management||KCT|
C - Cognitive/analytical
K - Subject knowledge
T - Transferable skills
P - Professional/Practical skills
Indicative content includes:
Clinical development programme planning: an integrated clinical development plan.
Design, management and interpretation of clinical trials across therapeutic areas.
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
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
Feedbacks are provided verbally during the exercise.
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.