HAR6116: Randomised Controlled Trials to Support Reimbursement Decision Making (online)


Introduction

Randomised controlled trials (RCTs) are of use when evaluating the effectiveness of interventions, as part of health technology assessment and decision-making. This module covers the appropriate use of trials, the range of available research designs, strategies to optimise recruitment, sample size, outcome measures, and the use of economic and qualitative methods alongside trials.

Objectives

This module aims to give students critical awareness of the issues involved in using randomised controlled trials (RCTs) to inform international health technology assessment decision-making.

Learning outcomes

By the end of the module, students will be able to:

  • Differentiate across a range of research methodologies and trial designs, to evaluate their appropriate use
  • Critically evaluate the critical elements of trial design and analysis
  • Design and plan a clinical trial within international and good practice procedures and guidelines, in the context of commissioning health technologies
  • The evaluation of superiority and bioequivalence

Teaching Methods

  • Bespoke online material for the course will present the principles and techniques of trial design, and describe the procedures required to develop and undertake an RCT.
  • Exercises based around case studies of real trials will help develop students’ critical understanding of trial design and analysis and their skills in designing a clinical trial.
  • Guided independent study of methodological texts will deepen their understanding of issues in the design and analysis of trials.

Assessment

Component Weighting
Assignment (3,000 words) 100%

The module will be assessed through a single 3000 word assignment, which will together test knowledge and theoretical understanding of appropriate use of the range of trial methodologies, design and analysis of trials and practical procedures for undertaking trials. The assignment will test that students understand the range of issues addressed in the module.

The pass mark is 50%.