Clinical Trials Design and Statistical Analysis (ICTM0011)

Key information

Faculty: Faculty of Population Health Sciences
Teaching department: Institute of Clinical Trials and Methodology
Credit value: 15

Restrictions: N/A
Timetable

Alternative credit options

There are no alternative credit options available for this module.

Description

This module aims to introduce different trial designs appropriate for different phases and settings and to provide an introduction to statistical design and analysis which the students require both to understand and critique research evidence and also to help them with their research project.

The following topics will be covered:

Phases of clinical trials
Trial design as applicable to Phase 1/2/3 (3+3 vs model-based designs; single-arm vs randomised designs; parallel, factorial, cross-over; seamless designs, innovative clinical trial design for precision medicine: umbrella, basket, adaptive study designs)
Sample size calculations with practical examples
Choosing appropriate outcome measures
Analysis - descriptive statistics, hypothesis testing, analysis of continuous, binary and time-to-event data
Performance characteristics of clinical tests: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV)

Module deliveries for 2024/25 academic year

Intended teaching term: Term 1 听听听 Undergraduate (FHEQ Level 6)

Teaching and assessment

Mode of study: In Person
Methods of assessment: 100% Exam
Mark scheme: Numeric Marks

Other information

Number of students on module in previous year: 0
Module leader: Dr Hakim-moulay Dehbi
Who to contact for more information: ictm.ibsc-clinicaltrials@ucl.ac.uk

Last updated

This module description was last updated on 19th August 2024.

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Important information

The catalogue has been updated with key information about the modules that will run during the 2024/25 academic session. Current and prospective students can browse through the catalogue to consider possible module choices for the coming year.

Please note,听information in the catalogue is听subject to change as teaching and assessment arrangements for 2024/25 may need to be adjusted in line with the University's Feedback and Assessment principles and operating model.

Centrally managed exam durations will be provided on students' individual exam timetables. Arrangements for locally managed exams and in-class activity will be confirmed by the teaching department for the module.

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