
Course unit details:
Biostatistical concepts in clinical trials
Unit code | PHAR69931 |
---|---|
Credit rating | 15 |
Unit level | FHEQ level 7 – master's degree or fourth year of an integrated master's degree |
Teaching period(s) | Semester 1 |
Offered by | Pharmacy |
Available as a free choice unit? | No |
Overview
This unit is designed to give the student an understanding of fundamental statistical concepts that are routinely used in designing clinical trials or interpreting trial results.
Emphasis is given to the use of simple hands-on exercises to build confidence in the application of concepts and in the practical use of software for statistical problem solving.
This unit is a prerequisite for the subsequent unit (PHAR69923) on advanced approaches to data analysis, including mixed effects models and population pharmacokinetics.
Theoretical knowledge will be disseminated first by lecture, but the unit will emphasise the application of theory by solving problems in workshops and coursework assignments. Some of the assignments will be computer based, to ensure students are comfortable with basic software for data analysis and presentation before encountering more specialised software in subsequent units.
Students will complete exercises using Microsoft Excel and will also be introduced to more specialised software such as R and Matlab
Aims
The unit aims to:
- Introduce statistical concepts applied in the design of clinical trials and interpretation of clinical results in drug development.
- Provide practice in applying statistical methods to typical clinical trial data.
Syllabus
Basic statistical concepts and definitions
Types of data
Probability concepts
Estimation
Confidence intervals
Hypothesis testing/ significance testing
Trial design
Choice of variables
Control groups
Randomisation
Blinding
Sample size and power
Statistical analysis methods
Types of variables
Time to event data
Statistical analysis issues
The statistical analysis plan (SAP) in clinical research
Knowledge and understanding
Students should be able to:
- Define and apply the statistical terms relevant to clinical trial data collection and interpretation.
- Explain the crucial roles biostatistics in guiding the design and conduct of clinical trials.
Intellectual skills
Students should be able to:
- Apply basic biostatistical concepts and interpret statistical information arising from clinical trials.
- Perform power calculations and apply them in the design of a clinical trial
- Understand the statistical terms presented in clinical trial documents
Practical skills
Students should be able to:
- Use computer software such as Excel or R to perform basic computational tasks including file input/output, calculations, and production of effective graphs
Transferable skills and personal qualities
Students should be able to:
- independent learning, mastering new software
Assessment methods
Method | Weight |
---|---|
Other | 60% |
Written exam | 40% |
Biostatistics problems x 3 coursework - online - 60% of unit mark
Formative assessments x 4 - Model answers presented in tutorial - marks do not contribute to unit mark
Recommended reading
ICH E9 Statistical Principles for clinical trials. ICH E9 Statistical Principles for clinical trials.
Senn S. Statistical Issues in Drug Development. John Wiley & Sons. Chichester. 1997
Armitage P, Berry, G, Mathews JNS. Statistical Methods in Medical Research. Blackwell Publishing, Oxford. 2002.
BMJ statistics notes. (Altman et al.)
Study hours
Scheduled activity hours | |
---|---|
Lectures | 10 |
Seminars | 20 |
Tutorials | 4 |
Independent study hours | |
---|---|
Independent study | 116 |
Teaching staff
Staff member | Role |
---|---|
Leon Aarons | Unit coordinator |