Graduate Diploma in Clinical Research

Identifying the most appropriate study design is important for generating the best evidence to answer a clinical research question. A well-designed study will clearly identify a range of variables including the participant population, the intervention or exposure of interest and the outcomes to be investigated and how data will be collected. Understanding the various indications for different study designs is important for not only devising a new study but also for critically reviewing published studies.

This subject will provide students with an in-depth understanding of the principles and application of a variety of study designs in a clinical/medical setting. Key areas that will be covered include:

1. examining the range of quantitative, qualitative and mixed-methods approaches such as

• experimental and quasi-experimental, cohort, cross-sectional and single-subject designs;
• participant observation, in-depth interviews, case-studies, focus groups and artefact analysis designs;
• screening, preventive and genetic/biomarker trials
• construction and administration of surveys and questionnaires and;
• the use of clinical bioinformatics, e-health and large population datasets.

2. strategies for matching study aims/objectives with selection of an appropriate study design
3. exploring sources of bias in research such as randomization, allocation, concealment and blinding and their relationship to the principles of internal and external validity
4. using published reporting guidelines (eg CONSORT statement) to aid in the design and reporting of a study
5. participant recruitment/retention/attrition, outcome measure selection and the application of power calculations
6. the principles of drug evaluation and regulation

It is critically important that you understand your responsibilities as a clinical researcher prior to undertaking any clinical research. These responsibilities originate from the very fundamentals – What is research? Why do we do it? How does it work? In this subject, we will discover the key responsibilities that apply to clinical research. Ensuring that clinical research is conducted ethically, as well as responsibly, is also very important. This importance goes beyond ‘simple’ compliance.

Data analysis methods are an integral part of modern clinical research. They are powerful techniques that enable researchers to draw meaningful conclusions from data collected through observation, survey, or experimentation.

However, data analysis is a huge discipline with different paradigms, schools of thought and alternative methodologies. Therefore consideration of the appropriate methods used must be undertaken when designing a study and selecting variables and groups.

This subject introduces students to the basic principles of qualitative and quantitative data analysis techniques. It will provide a functional grounding in the theoretical concepts behind each type of analysis, as well as exploration of the interpretation of data and the difference, where applicable, between clinical vs statistical significance.

Analysis techniques to be explored include:

Quantitative

• Descriptive statistics
• Principles of statistical inference
• Cross-tabulations: Chi-Square, Fisher's exact test, relative risk, and odds ratios
• Comparisons of means: t-tests and ANOVA
• Linear association: correlation and simple regression
• Measurement of exposure
• Sample size and power
• Data storage, management, collation and coding
• Quantitative analysis software

Qualitative

• Documentation of data and the process of data collection
• Data transcription
• Effective data storage and management
• Requirements of data coding
• Iterative, content/thematic, narrative, discourse, framework and grounded theory analysis
• Writing up qualitative research
• Qualitative analysis software

Medical research studies can be split into five distinct phases—conception, design, execution, analysis, and publication/reporting. The quality of a study is highly dependent on the selection of a proper study design and this in turn is determined by the research question to be answered.

This subject will introduce participants to the principles of research within a clinical (ie health) setting, in particular:

• turning an idea into a research question that is measurable and evaluable
• examine different study designs used in clinical/medical research
• selecting a study design appropriate to answering the research question
• refining a research question by examining the current literature through the construction of a 'literature review' of published scientific studies
• assessing the strengths, weakness and biases of qualitative and quantitative study designs commonly encountered in the medical literature
• literature searching and critical appraisal of published scientific

This subject provides individuals from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a biomedical science-based background with a conceptual framework in research which is undertaken in clinical and medical settings. This subject serves as a basis for advanced study in the Graduate Certificate in Clinical Research, the Graduate Diploma in Clinical Research and the Master of Clinical Research.

This subject examines the processes involved in planning a clinical research project from the research proposal development stage, to project management, implementation and research translation. This subject will introduce learners to different strategies for implementing a clinical research project and provides the foundational knowledge required for developing an effective clinical research program.

Intensive Teaching Period 1 (3 days):
• The development of clinical research proposal/grant
• Examination of potential regulatory requirements and ethical, legal and compliance issues.
• Construction of a business plan and budget for clinical research projects
Intensive Teaching Period 2 (3 days):
• Managing research projects and teams
• Intellectual property law: Legal considerations to translating new research findings
Intensive Teaching Period 3 (3 days):
• Explore the principles of knowledge translation and strategies for dissemination, engaging policy and decision makers and clinical guideline development. 
• Evaluation strategies to determine effectiveness of a research translation strategy

This subject builds on the knowledge and skills acquired in the Graduate Certificate in Clinical Research, and builds towards the knowledge required for more detailed study in the Master of Clinical Research.

This subject has been designed to bring together a multi-disciplinary group of candidates (students) and give them a broad understanding of the essential elements / features of successful research activities and research careers in oncology.

Topics covered include:

• Frontiers in clinical neuroscience research
• Expert briefings on the current research questions in epilepsy, intellectual disability and autism, stroke and multiple sclerosis
• Research methods in clinical neurological genetics
• How animal models can inform clinical neuroscience research
• Research methods in clinical neuropharmacology
• Brain development
• Neuroplasticity and neurotrophic factors research
• Research methods in neurodegenerative disorders
• Clinical trials methods
• How clinical research informs basic research and vice-versa
• Research methods in neurological epidemiology
• Research methods in neurological rehabilitation
• Translation of clinical research findings into practice

Topics covered include:

• Expert briefings on the current research questions in dementias, movement disorders, schizophrenia and bipolar disorders.
• Major emphasis on cutting-edge human imaging techniques
• Cognitive functioning
• Research techniques in clinical neurophysiology
• Introduction to neuroimaging techniques
• Principles of magnetic resonance imaging (MRI)
• Practical demonstration of language functional MRI
• Structural MR imaging and clinical research applications
• Functional MR imaging and clinical research applications
• Analysis of MR imaging
• Magnetic resonance spectroscopy and research applications
• New frontiers in multi-disciplinary clinical neuroscience research

In this subject students will have the opportunity to undertake a small clinical research investigation in an area of clinical interest. In consultation with a research supervisor and/or the course coordinator, participants will formulate a research question and undertake a systematic or literature review to evaluate the published evidence to synthesize an answer to their research question. This subject will provide participants with the practical knowledge required to plan an evidence based clinical research project with consideration given to the process and requirements of ethics approval.

AIMS

This subject familiarises students with core informatics tools and methods used in eHealth, translational research, simulation and modelling, and biomedical knowledge management. It also provides students with insights into research trends in the field of biomedical informatics.

INDICATIVE CONTENT

Five major topics will be covered in lectures, tutorials and hands-on computer labs:

1. How can we manage clinical data? Students will gain exposure to: informatics tools and methods for ehealth and broadband-enabled health, including shareable medical records, telehealth, mobile health; terminologies, coding and standards e.g. SNOMED-CT, HL7A and secure messaging, medical imaging (DICOM) and lab data (LOINC); and clinical decision support systems.

2. How can we integrate clinical data with molecular, population, environmental and other data sources? Students will gain exposure to: informatics tools and methods for translational research, including genomic data sources (microarray and next generation DNA sequencing); data integration and analysis platforms such as BioGrid, CaBIG. Gene ontology; and clinical research informatics (clinical trials).

3. How can we use computer models to simulate human biology and disease? Students will gain exposure to: informatics tools and methods for simulation and modelling; anatomical ontologies (FMA); VPH and Physiome platform; and infodemiology tools, systems medicine, virtual environments for clinical practice.

4. How can we manage health and biomedical knowledge? Students will gain exposure to: informatics tools and methods for biomedical informatics research, including bibliographic and web information; MeSH, and databases; biomedical text mining; social and semantic web for health and life sciences; technology assessment; and systematic reviews and meta-analyses.

5. How can we develop the next generation of health and bioinformatics tools and methods? Students will gain exposure to trends and advances, including extreme phenotyping, informatics for personalised, regenerative and nanomedicine.

AIMS

ICT is an important component to ensuring quality, safety, access and efficiency in healthcare. This subject introduces current approaches and future directions in eHealth and the use of ICT in healthcare generally as well as key concepts and tools from the underlying discipline of health informatics.

INDICATIVE CONTENT

Topics include electronic health records (EHRs); hospital and primary care and public health information systems; supporting clinical decision-making for health professionals through ICT; eHealth in the community for preventive healthcare and for patient and carer support; regulatory influences on eHealth including management and governance, privacy, security, and confidentiality; the role of data standards, vocabularies, and nomenclatures in eHealth; research and development in eHealth.

Information and communication technology is an important factor in quality, safety, access and efficiency in healthcare. This subject provides an overview of digital health and the influence of ICTs in clinical care, as well as in clinical research, population health and healthcare system planning.

Digital health current approaches and future directions are explored from the perspectives of health and biomedical sciences, information science and technology, management sciences, and behavioural and social sciences- that is, within major health informatics competency frameworks such as the Certified Health Informatician Australasia (www.healthinformaticscertification.com) and the American Medical Informatics Association (http://www.cahiim.org/hi/curriculumrequirements.html ).

In addition to providing a clinically-oriented introductory subject in the University’s Graduate Certificate in Health Informatics and Digital Health, it is also suitable for single subject enrolment by practising clinicians or postgraduate students in any clinical health profession.

Clinical trials are designed to test new methods of screening, prevention, diagnosis and treatment of disease and are essential to discovering whether new healthcare interventions improve outcomes for patients. This subject will provide students a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials, in particular the randomized controlled trial (RCT), and will build on the concepts introduced at the graduate certificate level. Fundamental concepts associated with the design, implementation and analysis of RCTs will be explored including selecting, recruiting and consenting study subjects, determination of study duration, comparing multiple groups and/or endpoints, designing randomisation protocols, study monitoring, quality assurance and early termination.

Delivery will be across three intensive teaching periods:

Intensive Teaching Period 1 (3 days)

Trial Design
Randomization, Blinding and Allocation
Outcome Selection

Intensive Teaching Period 2 (3 days)

Good Clinical Practice
Quality Assurance & Regulatory Processes
Study Management
Informed Consent

Intensive Teaching Period 3 (3 days)

Stakeholder Involvement
Compliance and Follow-Up
Data Storage, Management and Analysis
Clinical Trials in Rural/Remote & Vulnerable Populations

This subject provides individuals from medical and allied health professions (such as nurses, pharmacists, physiotherapists etc) and others with a biomedical science-based background with a conceptual framework in design, development and conduct of RCTs. This subject serves as a basis for advanced study in the Master of Clinical Research.