# Statistics for Clinical Trials

## Overview

Plan, execute and interpret statistical analysis of clinical trials

This course in practical statistics for clinical trials covers protocol development and statistical analysis planning, statistical methods for testing for differences and estimating effect sizes, and the presentation and interpretation of results.

The primary focus of this course is to provide an understanding of the key statistical components required when conducting randomized clinical trials in accordance to the ICH E9 guideline, and for individuals to be able to demonstrate competencies in these components and apply them to clinical trials.

The overall aims of this module are to enable students:

To gain competence in execution and interpretation of core statistical techniques used by medical statisticians in randomized clinical trials, including:

• Understanding the key statistical components involved in the planning and conduct of clinical trials (i.e.):
• Awareness of different populations for analysis and understand which is appropriate to address specific research questions
• Awareness of different types of outcomes and be able to select the appropriate statistical technique for the type of outcome and study design
• Understanding and interpreting treatment effects, confidence intervals and P values
• Awareness of approaches to handling missing data and use of sensitivity analysis to test missing data assumptions
• Understanding how and when to conduct covariate adjustment and subgroup analysis
• Understanding how P values and confidence intervals are adjusted when multiplicity is present
• Understanding different types of trial designs and be able to choose the relevant design for a given question.
• Understanding issues to consider when designing a trial, including defining a primary outcome, carrying out sample size calculation, and analysing trial data.
• Demonstrating the ability to carry out sample size calculation for, at least, two arms parallel superiority trials
• Demonstrating the ability to prepare a statistical analysis plan
• Demonstrating the importance of interim analysis and stopping guidance for data monitoring committee.
• Understanding and applying statistical considerations when preparing a protocol or grant application.

This module assumes the students have at least some familiarity with the following:

• Distinction between continuous and categorical variables
• Interpretation of p values and statistical significance
• Interpretation of confidence intervals
• Concept of the Normal distribution

The last date for receipt of complete applications is 5pm Friday 12th April 2024. Regrettably, late applications cannot be accepted.

## Programme details

This module is run over an eight week cycle where the first week is spent working on introductory activities using a Virtual Learning Environment, the second week is spent in Oxford for the face to face teaching week (this takes place on the dates advertised), there are then four Post-Oxford activities (delivered through the VLE) which are designed to help you write your assignment. You then have a week of personal study and you will be required to submit your assignment electronically the following week (usually on a Tuesday at 14:00 UK Local Time).

## Fees

Description Costs
New students enrolled on MSc in EBHC £2340.00
Short Course in Health Sciences £2890.00

## Funding

Details of funding opportunities, including grants, bursaries, loans, scholarships and benefit information are available on our financial assistance page.

### Discounts

If you are an employee of the University of Oxford and have a valid University staff card you may be eligible to receive a 10% discount on the full stand-alone fee. To take advantage of this offer please submit a scan/photocopy of your staff card along with your application. Your card should be valid for a further six months after attending the course.

## Tutors

### Ms Ushma Galal

#### Module Co-ordinator

Ushma Galal is a Senior Trial Statistician at the Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford.

### Dr Milensu Shanyinde

#### Module Co-ordinator

Milensu Shanyinde is a Senior Medical Statistician at the Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford.

## Assessment methods

Assessment will be based on submission of a written assignment which should not exceed 4,000 words.

Applicants may take this course for academic credit. The University of Oxford Department for Continuing Education offers Credit Accumulation and Transfer Scheme (CATS) points for this course. Participants attending at least 80% of the taught course and successfully completing assessed assignments are eligible to earn credit equivalent to 20 CATS points which may be counted towards a postgraduate qualification.

Applicants can choose not to take the course for academic credit and will therefore not be eligible to undertake the academic assignment offered to students taking the course for credit. Applicants cannot receive CATS (Credit Accumulation and Transfer Scheme) points or equivalence. Credit cannot be attributed retrospectively. CATS accreditation is required if you wish for the course to count towards a further qualification in the future.

A Certificate of Completion is issued at the end of the course.

## Application

This course requires you to complete the application form and to attach a copy of your CV. If you are applying to take this course for academic credit you will also be required to provide a reference. Please note that if you are not applying to take the course for academic credit then you do not need to submit a reference.

Please ensure you read the guidance notes which appear when you click on the symbols as you progress through the application form, as any errors resulting from failure to do so may delay your application.

## Selection criteria

To apply for the course you should:

• Be a graduate or have successfully completed a professional training course
• Have professional work experience in the health service or a health-related field
• Be able to combine intensive classroom learning with the application of the principles and practices of evidence-based health care within the work place
• Have a good working knowledge of email, internet, word processing and Windows applications (for communications with course members, course team and administration)
• Show evidence of the ability to commit time to study and an employer's commitment to make time available to study, complete course work and attend course and university events and modules
• Show evidence of your previous statistical knowledge
• Be able to demonstrate English Language proficiency at the University’s higher level

## Accommodation

Accommodation is available at the Rewley House Residential Centre, within the Department for Continuing Education, in central Oxford. The comfortable, en-suite, study-bedrooms have been rated as 4-Star Campus accommodation under the Quality In Tourism scheme, and come with tea- and coffee-making facilities, free Wi-Fi access and Freeview TV. Guests can take advantage of the excellent dining facilities and common room bar, where they may relax and network with others on the programme.

## IT requirements

Please ensure that you have access to a computer that meets the specifications detailed on our technical support page.