HSC8100 : Clinical Trials with Advanced Topics
- Offered for Year: 2025/26
- 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 | |
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.
Additional advanced topics such as use of time-to-event outcomes, methods for multiplicity correction and stepped wedge trials will also be considered.
Teaching Methods
Teaching Activities
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| 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 |
| Guided Independent Study | Assessment preparation and completion | 1 | 2:00 | 2:00 | Unseen exam |
| 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 |
| 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 | Practical | 3 | 1:00 | 3:00 | Computer Practicals |
| Guided Independent Study | Directed research and reading | 15 | 1:00 | 15:00 | Directed reading of advanced topic(s) |
| Guided Independent Study | Independent study | 8 | 1:00 | 8:00 | Background reading on lectured content |
| Guided Independent Study | Independent study | 13 | 1:00 | 13:00 | Revision of unseen exam |
| 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 |
| Total | 100:00 |
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. In addition, directed research and reading of an advanced topic is used to develop the students’ ability to learn independently.
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.
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 |
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.
Reading Lists
Timetable
- Timetable Website: www.ncl.ac.uk/timetable/
- HSC8100's Timetable