The candidate will develop the skills necessary to synthesize evidence both in preparation for conducting a trial and how to incorporate trial results into existing evidence. This will include being able to conduct a systematic review of the literature, including understanding how to appropriately assess evidence. The principles of meta-analysis to combine the results of multiple trials will also be examined as well as the interpretation of these results and how they can be used in clinical practice guideline development. As part of the critical appraisal of available evidence, different patient outcomes and the corresponding summary endpoint measures will be examined. Additionally the sources of biases arising from different trial designs and outcome measures will be covered and incorporated as part of the critical appraisal of available evidence (including published papers).

This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaption of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.

This unit addresses a number of key issues that arise in the analysis of clinical trial data. It will equip students with the ability to critically evaluate and interpret trial analyses, as well as provide them with an understanding of the principles underpinning good analysis practices. Modules will provide an introduction to the interpretation of treatment effect estimates, adjusted analyses, subgroup analysis, interim analyses, and how to reach appropriate decisions about the continued evaluation of an intervention, or its recommended implementation in practice.

The candidate will understand how to effectively form, lead and successfully manage a clinical research project. The subject will address issues related to resource management (including team and finance). The key elements of putting together a solid funding application and developing a study protocol will also be covered. Specialized aspects of trial management and conduct will be presented. Issues involved in study start up (initiation), monitoring and quality assurance (including audit), and study outcome collection will be introduced. Aspects of scientific leadership including skills to address/solve problems in recruitment, follow up and event assessment will be taught. Students will gain a detailed understanding of how to plan for issues arising during a clinical trial in a practical sense including dealing with unexpected events during a trial, addressing event rates lower than that expected, changes in outcome definitions and ethical dilemmas. This is a key subject where students will gain an understanding of how to apply theory to practice.

Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.

The special skills of translational research will be highlighted in this unit. Candidates will understand the potential uses for biomarkers in clinical practice; how to use study designs relevant for biomarker evaluation and how to incorporate biomarker studies and biospecimen (tissue and blood) collection into clinical research projects. Candidates will learn the difference between prognostic, predictive and surrogate biomarkers and biostatistical considerations in their analysis. The complexities of international regulations regarding patient consent, biospecimen collection and shipment will be highlighted.

Statistical principles and concepts required to design, lead and manage clinical trials will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an understanding of simple and adjusted analyses. Students will undertake analyses of actual studies having outcomes which are continuous, binary and time-to-event including Kaplan-Meier and logrank tests. Concept and issues involved in performing landmark analyses will be introduced. Identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of detailed sample sized calculations for student's own trial proposals will be covered. Analyses will be performed using statistical software. SPSS and ACCorD software will be supported but students may use any package they are familiar with and have available. It is the student's responsibility to purchase the software. Details will be given at the beginning of the semester.

The capstone unit is a project which requires each student to bring together concepts, principles and applications developed in the previous units of coursework study into a workable research proposal and plan for the initiation and management of a clinical trial. The capstone will test the student's ability to integrate and consolidate their learning.

This unit of study will provide students with the knowledge and skills of translating clinical trials methods and theory into practice. Students will be introduced to principles of clinical trial project management including the management of patient recruitment and follow up, monitoring study progress, clinical trial budgeting and funding. This unit of study will also focus on the ethical and legal framework which governs clinical trials including ethics approval, informing patients, and obtaining consent in the context of clinical trials and various patient populations. A key feature of clinical trials relates to quality assurance aspects such as documentation of study procedures and clinical trial audit, consequently emphasis will be placed on the development of clinical trials reports, results and publications.