HSC3100 : Clinical Trials
HSC3100 : Clinical Trials
- Offered for Year: 2026/27
- Module Leader(s): Professor James Wason
- Co-Module Leader: Dr Nan Lin
- Owning School: Population Health Sciences
- Teaching Location: Newcastle City Campus
Semesters
Your programme is made up of credits, the total differs on programme to programme.
| Semester 2 Credit Value: | 10 |
| ECTS Credits: | 5.0 |
| European Credit Transfer System | |
Pre-requisite
Modules you must have done previously to study this module
| Code | Title |
|---|---|
| MAS2901 | Statistical Inference |
Pre Requisite Comment
MAS2903 and MAS2906 are also desirable rather than essential.
Co-Requisite
Modules you need to take at the same time
Co Requisite Comment
N/A
Aims
The aim of this module is to provide an understanding of statistical methods used for the design and analysis of Clinical Trials.
Clinical trials are undertaken to evaluate whether treatments are safe and effective. Statisticians play a vital role in helping to design clinical trials and analysing them. In the last decade there have been major developments in statistical methods used, with the aim of making trials more efficient and better for people who enrol on them.
This course will cover well-established and newer methods for design and analysis of clinical trials with examples from real trials.
Outline Of Syllabus
History of clinical trials and the advantages of randomisation in assessment of treatments; design of parallel group randomised trials, including sample size calculation; adjustment for covariates; methods for handling missing data and imperfect compliance, crossover and cluster-randomised trials, group-sequential and adaptive clinical trials; Bayesian methods for clinical trial design and analysis.
Learning Outcomes
Intended Knowledge Outcomes
At the end of the module it is expected that a student will be able to:
1. Outline how statistical methods are used to choose a suitable sample size for clinical trials.
2. Summarise issues that can occur in clinical trials, such as low compliance and missing data, and how more advanced statistical analyses can be used to address these issues.
3. Describe the advantages and disadvantages of recent developments in statistical methods for clinical trials such as innovative trial design.
Intended Skill Outcomes
At the end of the module a student will be able to:
1. Determine a suitable sample size for a clinical trial with normally distributed and binary endpoints.
2. Propose a suitable approach to analysing a clinical trial.
3. Use advanced methods for crossover, cluster-randomised and adaptive designs and available software to design them.
4. Apply the above in R software.
Students will develop skills across the cognitive domain (Bloom’s taxonomy, 2001 revised edition):
remember, understand, apply, analyse, evaluate and create.
Teaching Methods
Teaching Activities
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| Scheduled Learning And Teaching Activities | Lecture | 20 | 1:00 | 20:00 | Formal lectures |
| Guided Independent Study | Assessment preparation and completion | 2 | 4:00 | 8:00 | Completion of in course assessments |
| Guided Independent Study | Assessment preparation and completion | 1 | 2:00 | 2:00 | Unseen exam |
| Scheduled Learning And Teaching Activities | Lecture | 2 | 1:00 | 2:00 | Guest Lectures by statisticians with experience in the pharmaceutical industry (not examined) |
| Scheduled Learning And Teaching Activities | Lecture | 2 | 1:00 | 2:00 | Problem Classes |
| Scheduled Learning And Teaching Activities | Lecture | 2 | 1:00 | 2:00 | Revision lectures |
| Scheduled Learning And Teaching Activities | Practical | 3 | 1:00 | 3:00 | Computer Practicals |
| Guided Independent Study | Independent study | 22 | 1:00 | 22:00 | Preparation time of lectures |
| Guided Independent Study | Independent study | 2 | 1:30 | 3:00 | Review of coursework |
| Guided Independent Study | Independent study | 23 | 1:00 | 23:00 | Background reading on lectured content |
| Guided Independent Study | Independent study | 13 | 1:00 | 13:00 | Revision of unseen exam |
| Total | 100:00 |
Jointly Taught With
| Code | Title |
|---|---|
| HSC8100 | Clinical Trials with Advanced Topics |
Teaching Rationale And Relationship
Lectures are used for the delivery of theory and explanation of methods, illustrated with examples, and for giving general feedback on marked work. Problem classes are used to help develop the students’ abilities at applying the theory to solving problems.
The teaching methods are appropriate to allow students to develop a wide range of skills. From understanding basic concepts and facts to higher-order thinking.
Reading Lists
Assessment Methods
The format of resits will be determined by the Board of Examiners
Exams
| Description | Length | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|---|
| Written Examination | 120 | 2 | A | 80 | Written exam comprising a Section A and a Section B |
Exam Pairings
| Module Code | Module Title | Semester | Comment |
|---|---|---|---|
| Clinical Trials with Advanced Topics | 2 | N/A |
Other Assessment
| Description | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|
| Prob solv exercises | 2 | M | 20 | Coursework 2. Up to 6 page typeset report based upon a set assignment comprising open-ended questions |
Formative Assessments
Formative Assessment is an assessment which develops your skills in being assessed, allows for you to receive feedback, and prepares you for being assessed. However, it does not count to your final mark.
| Description | Semester | When Set | Comment |
|---|---|---|---|
| Prob solv exercises | 2 | M | Coursework 1. 40 minute class test, conducted during one of the timetabled one hour lecture slots |
Assessment Rationale And Relationship
A substantial formal unseen examination is appropriate for the assessment of the material in this module. The format of the examination will enable students to reliably demonstrate their own knowledge, understanding and application of learning outcomes.
Examination problems may require a synthesis of concepts and strategies from different sections, while they may have more than one way for solution. The examination time allows the students to test different strategies, work out examples and gather evidence for deciding on an effective strategy, while carefully articulating their ideas and explicitly citing the theory they are using.
The coursework assignments allow the students to develop their problem solving techniques, to practise the methods learnt in the module, to assess their progress and to receive feedback; the summative assessment has a secondary formative purpose as well as its primary summative purpose.
Timetable
- Timetable Website: www.ncl.ac.uk/timetable/
- HSC3100's Timetable
Past Exam Papers
- Exam Papers Online : www.ncl.ac.uk/exam.papers/
- HSC3100's past Exam Papers
General Notes
N/A
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The information contained within the Module Catalogue relates to the 2026 academic year.
In accordance with University Terms and Conditions, the University makes all reasonable efforts to deliver the modules as described.
Modules may be amended on an annual basis to take account of changing staff expertise, developments in the discipline, the requirements of external bodies and partners, staffing changes, and student feedback. Module information for the 2027/28 entry will be published here in early-April 2027. Queries about information in the Module Catalogue should in the first instance be addressed to your School Office.