University of Sydney Handbooks - 2019 Archive

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Clinical Trials Research

 

Clinical Trials Research

Core units

CLTR5001 Trial Design and Methods

Credit points: 6 Teacher/Coordinator: Rebecca Asher, Adrienne Kirby Session: Semester 1 Classes: discussion groups and problem based learning Assessment: 2 x short answer, including calculations quizzes (2x10%), 2 x short answer question, calculations, long answer questions and diagrams assignments (2x40%) Mode of delivery: Online
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.
Textbooks
Recommended reading: many available eg S Piantadosi, Clinical Trials A Methodological Perspective. KJ Rothman and S Greenland Modern Epidemiology. Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5000 Critical Appraisal of Evidence

Credit points: 6 Teacher/Coordinator: David Espinoza, Lucas Staub Session: Semester 1 Classes: discussion groups and problem based learning Assessment: Assessment: 2x short answer quizzes (2x10%), 2x long answer assignments (2x40%) Mode of delivery: Online
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).
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement. Other Sources: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. Available from www.cochrane-handbook.org.
CLTR5007 Statistical Principles and Clinical Trials

Credit points: 6 Teacher/Coordinator: Liz Barnes, Rebecca Asher Session: Semester 2 Classes: Discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: Two online quizzes multiple choice, multiple answer quizzes (2x 10%), two x assignments requiring analysis, calculations, presentation and interpretation of results (2x 40%) Mode of delivery: Online
Statistical principles and concepts required to design clinical trials and analyse trial results will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an introduction to hypothesis testing, confidence interval estimation and understanding of univariable and adjusted analyses. Students will undertake analyses of study data where outcomes are continuous, binary and time-to-event variables Concepts and issues involved in performing landmark analyses and in identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of sample size calculations for clinical trials will be covered. Analyses will be performed using statistical software. SPSS 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.
Textbooks
No set text, notes will be provided on eLearning. Other resources: spreadsheet sofware (e.g. Microsoft Excel), statistical software capable of performing standard statistical analyses (e.g. SPSS).
CLTR5009 Operational Principles of Clinical Trials

Credit points: 6 Teacher/Coordinator: Adrienne Kirby Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: online participation (5%); 1 x short answer questions quiz (15%); 2 x 2000-word essays (2x40%) Mode of delivery: Online
This unit of study will cover the principles of operationalizing a clinical trial. Students will acquire the knowledge needed to conduct quality studies providing research data and to comply with regulatory and legal requirements of a clinical trial. Areas covered will include single and multi-centre trials along with the roles and responsibilities of different trial personnel and committees. Costs of study resources and budgets, especially in relation to funding applications will be considered. Clinical trial project management including the management of recruitment and follow up, and monitoring study progress will be covered, along with the ethical and legal framework governing clinical trials. This will also include aspects of ethics approval and patient consent in various patient populations. Aspects of quality assurance in clinical trials including documentation of study procedures, clinical trial audits, and study monitoring will be discussed with emphasis placed on the development of clinical trials reports, results and publications.

Additional core units for diploma and master's students

CLTR5002 Interpretation of Trial Analyses

Credit points: 6 Teacher/Coordinator: Andrew Martin Session: Semester 1 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 and CLTR5007 Assessment: 1 x Appraisal of a case study (500 words) and peer review of anonymised student's submission (10%+5%), 1 x Short answer, multiple-choice quiz (60 min duration) (15%), 2 x Methodological appraisal of two case studies (500 words for each appraisal) (2x35%) Mode of delivery: Online
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.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5003 Leadership and Problem Solving

Credit points: 6 Teacher/Coordinator: Rebecca Mister, Katrin Sojquist Session: Semester 1 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 1xMultiple-choice/short answer quiz (10%), 1xshort answer question quiz (10%), 1xConcept outline development and justification (3 pages) (40%) , 3 x 2-page responses to scenarios (40%) Mode of delivery: Online
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.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.

Elective units

CLTR5004 Advanced Trial Design

Credit points: 6 Teacher/Coordinator: Rachel O'Connell Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 and CLTR5007 Assessment: 2x short answer, some calculations quizzes (2x10%), 2x long answer assignments (2x40%) Mode of delivery: Online
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.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5005 Biomarker Studies

Credit points: 6 Teacher/Coordinator: Chee Lee, Sally Lord, Sonia Yip Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 2x short-answer quizzes (2x10%), 2x short-answer assignments (2x40%) Mode of delivery: Online
The special skills and techniques 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.
Textbooks
Recommended reading: Altman DG, McShane LM, Sauerbrei W, Taube SE (2012)Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): Explanation and Elaboration.PLoS Med (5): e1001216. doi:10.1371/journal.pmed.1001216
PCOL5101 Drugs and Devices: R and D to Registration

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong, Dr Rania Salama, Prof Paul Young, Prof Daniela Traini Session: Semester 1 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%) written assignments (45%), presentations(15%) Mode of delivery: Online
This unit of study provides a broad overview of the processes involved in translating a new drug, formulation and/or pharmaceutical delivery device from a laboratory setting to a final approved product. It is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. Three core areas are covered: (1) the regulatory organisation, (2) requirements during drug discovery, manufacture and clinical trials, and (3) post-registration pharmacovigilance and pharmacoeconomics. Students will gain knowledge of the Therapeutic Goods Administration (TGA) and guidelines for the registration and regulation of medical devices and medicines. Students will also learn the importance of international regulations, harmonisation and application to the Australian market. The unit will also cover R and D; manufacturing and clinical trial requirements; the concepts of good laboratory and manufacturing practices (GMP, GLP) and quality by design (QbD); as well as regulator accepted laboratory methodologies used for submission of product dossiers. The basics of clinical trial design will be analysed, as well as concepts of pharmacokinetics, dynamics, pharmacoeconomics and clinical endpoints for registration of new products using case studies and online tutorials. Special requirements for the registration and testing of generic medicines will also be part of the unit.
Textbooks
online readings and other learning resources will be provided.
PCOL5102 Modern Therapeutics and Medical Devices

Credit points: 6 Teacher/Coordinator: Dr Hui Xin Ong, Dr Rania Salama, Prof Paul Young, Prof Daniela Traini Session: Semester 2 Classes: online lectures, podcasts, discussion boards, webinars Assessment: online quizzes (20%), short answer questions (20%), written assignments (45%),presenttions (15%) Mode of delivery: Online
This unit of study develops knowledge in current state-of-the-art therapeutic technologies. The principles of mode of action are investigated, along with methods of manufacture and registration. The unit is targeted at people in the pharmaceutical industry, advisors in the regulatory sector and those wishing to enter the industry. It covers 4 core areas, reflecting different aspects of medicines regulation in Australia: (1) biologicals and personalised medicine, (2) cell based products, (3) medical devices and (4) classical formulations. The principles that underpin these innovative therapies are covered in terms of development, targeting and manufacture along with the application of genomics in personalised medicine. Students will investigate the processes of manufacture, verification and validation testing to ensure regulations are met. Cellular immunotherapy for cancer treatment is an emerging area. Students will gain knowledge of the different types of therapies within this space. Registration of medical devices will be covered. Case studies will be evaluated, including the challenges associated with bringing these therapies and devices to market. Classical formulations (i.e. oral, repiratory and injectable dosage forms) will be covered and advances within the field such as regulation of nanotechnology will also be discussed.
Textbooks
online readings and other learning recourses will be provided.

Capstone for master's students

CLTR5008 Research Project

Credit points: 6 Teacher/Coordinator: Chris Brown, Val Gebski Session: Semester 2 Prerequisites: CLTR5001 and CLTR5007 Assessment: Satisfactory completion of each of: 5 x participation activities; 1 x short answer questions assignment activity; 1 x concept outline (2 pages), 2 x 2000-word essays Mode of delivery: Online
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.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.