Program Overview

Introduction to Clinical Trial Design and Analysis

Course Fact File

Outline

Module Objective

Students will learn the fundamental elements of clinical trial design.

Module Content

Review of basic probability theory; frequentist statistical inference; causal inference in clinical trials; sample selection; randomization; allocation concealment; outcomes; baselines and covariates; sample size and power; 2-arm parallel trials; linear models; regulatory advice on trial design and analysis.

On successful completion of this module, students should be able to:

1. Describe the value of concurrent controls with reference to specific examples.
2. Describe the value of randomisation in a clinical trial, with reference to both statistical and causal inference.
3. List the information needed to calculate a sample size, explain what study power is and how to achieve it, and demonstrate the ability to calculate a sample size when provided with the necessary inputs.
4. Demonstrate how inappropriate categorisation impacts the power of a study.
5. Compare and contrast the use of change scores as an outcome with adjustment for baseline outcome.
6. Discuss the usefulness of covariate adjustment.
7. Explain the importance of allocation concealment for the integrity of a trial, and evaluate commonly used methods for achieving it.
8. Apply what was learned over the course to design a 2-arm parallel trial.

Additional Teaching Mode Information

• 48 1 Hr(s) Online asynchronous (any time learning) activities
• 4 1 Hr(s) Workshops

Practicalities

• 33 Hr(s) Directed Learning
• 20 Hr(s) Online Asynchronous (Any Time Learning) Activities
• 145 Hr(s) Independent Enquiry

Assessment

Total Marks 200

• Discussion Board(s) - Contribution to online discussion boards as prescribed (20 Marks)
• Assignment - Written assignment(s) submitted online (100 Marks)
• Quiz(zes) - Online MCQ's (80 Marks)

Why Choose

EH6124 is one of the modules of the Postgraduate Certificate in Clinical Trials.

This programme is designed for the working professional who wishes to develop a career in clinical trials.

As part of UCC's commitment to Continuing Professional Development (CPD), Holders of CPD certificates for clinical trial modules in UCC will be exempt from these modules within the Postgraduate Certificate if they undertake the Postgraduate Certificate within 24 months of completion of any CPD module. Should students undertake two CPD modules from the Postgraduate Certificate Clinical Trials, they will be unable to take the third Postgraduate Certificate module as a CPD module without first registering for the Postgraduate Certificate Clinical Trials.

Requirements

Academic Requirements

1. Students are expected to hold an honours primary degree (NFQ Level 8), minimum second class honours grade 2, or equivalent, in a Science or health related discipline, or relevant subject area.

Professional Requirements

1. Also open to registered health care professionals in Medicine, Nursing, Pharmacy and Allied Health care disciplines who may not have a primary degree. Such applicants must provide evidence of current registration with the relevant professional regulatory body in their country (e.g. the Irish Medical Council, the Nursing and Midwifery Board of Ireland, the Pharmaceutical Society of Ireland etc. for Irish applicants).
2. All applicants will be required to write a 500 word personal statement on why they wish to pursue a career in clinical trials.
3. In exceptional circumstances, candidates with an honours primary degree (NFQ Level 8 or international equivalent) in an unrelated field, and who can demonstrate relevant experience in clinical research, may be considered for entry to the programme, subject to the approval of the programme team.
4. Applicants may be asked to participate in an interview.
5. In all cases, decisions will be based on qualifications and quality of application.

Technical Entry Requirements (Online)

This programme will be delivered wholly online. As such there are specific technical requirements that you need to meet.

1. You will need access to a laptop or desktop (either Mac OS or Windows) running a relatively recent operating system (Windows 7, 8, 8.1, 10 or Mac OSX 10.8, 10.9, 10.10). Tablets and smartphones are not officially supported by UCC.
2. You will need access to a reliable broadband connection with at least 2MB download speeds. You can test your broadband or 4G speeds by visiting.
3. You must have a modern web browser installed. The most reliable options for use with UCC online learning are Mozilla Firefox and Google Chrome. Download and installation instructions will be provided. Safari is not suitable.
4. You must have Java and Flash Runtimes installed. Download and installation instructions will be provided.
5. You will require an Office suite of software (Microsoft Office 2003 or later or equivalent) and a PDF reader (preferably Adobe Acrobat Reader XI or later). Please note that registered UCC students have access to discounted software from Microsoft and Adobe.

Fees and Costs

€1,350.00. There is also a €35 application fee.