Concept Development Scheme

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Research Workshops

Paediatric Trials Network Australia (PTNA) has licensed the Murdoch Children’s Research Institute (MCRI) developed Clinical Trials Workshop series for use by PTNA member sites. 

The Series of 5 introductory CRDO CORE workshops are interactive and provide a practical introduction to clinical research. They are principle-based and run for approximately 3.5 hours. Please note, the Good Clinical Practice (GCP) workshop runs for 4 hours and you may choose to enrol in this as a stand-aloneoption, if you prefer not to take the series of 5 introductory workshops. To find out more and register online please follow this link MCRI WORKSHOPS

Modules available for PTNA member site use are outlined below and the course has been designed to be facilitated over 5 weeks with 1 x 3.5 hour session per week. Modules covered during this series are:

  • Guidelines & Legislation in Research 

Conducting research in accordance with all the rules and regulations that govern research in Australia can be daunting. This workshop will review the national guidelines and legislation that govern the way we conduct research, including the NHMRC National Statement, the NHMRC Code for the Responsible Conduct of Research, as well as the Privacy and Health Records Act. Through activities, you will learn why it’s essential that your research project meets these requirements and how to imbed the principles into your project.

  • The Ethics Review Process- What you need to know 

From a new project application through to submission of the final report and everything in between, discover what the HRECs and Research Governance Offices require from you, when it’s required and why. This session will also demystify the National Ethics Application Form (NEAF) and Victorian Specific Module (VSM).

  • Informed Consent Essentials 

Obtaining valid consent is a vital, active and ongoing process in research. In this workshop you will learn why informed consent is required, what it is and how to obtain it. This workshop will focus on how to write high quality Participant Information and Consent Forms (PICFs) and on the role of communication in the consent process.

  • Good Clinical Practice (GCP) = Good Research Practice 

To conduct high quality research, Australian researchers need to be compliant with national regulations governing research in Australia. In addition to the regualtions reviewed in the first workshop, Australian researchers are increasingly required to comply with international Good Clinical Practice (GCP) guidelines in the form adopted by Australia’s Therapeutic Goods Administration (TGA). This TransCelerate-recognised, 4-hour GCP workshop will provide an understanding of the key principles and requirements. Working in small groups, participants will learn how to identify principles in common research scenarios.

TransCelerate-recognised GCP certification is mandatory for all staff working on industry sponsored trials and, at most institutions, for principal investigators working on investigator-initiated or collaborative trials. This workshop is also provided as a stand-alone workshop for those not wanting or needing to enrol in the series of core workshops. 

  • Bringing it together – How to successfully run your research project 

This session will explore the tools you will need to run a research project from set up and day-to-day management through to close out and archiving.  

Health Economics for Clinical Trials

PTNA has partnered with the Centre for Health Policy at The Universityof Melbourne to bring you access to Health Economics experts to assist with your paediatric clinical trial grants and to build economics into your trial design regardless of where you are located. This is one of the ways PTNA can add value at the trial concept phase.

Over the last 3 decades in Australia we have seen a large increase in the number of applications for funding for clinical trials through funding bodies like NHMRC but at the same time the rates of success have fallen. 

In this competitive environment economic evaluation can be a useful addition to clinical trial design. Economic evaluation and cost-effectiveness analysis are increasingly expected as part of a funding application.

Economic evaluation aims to assess the additional costs of the intervention relative to the additional benefits achieved. It can be helpful in establishing a case for funding a particular intervention over and above others. Estimates of the costs of scaling an intervention to a state/national level are possible to inform budgets for broader implementation plans.

Economics focuses on real world application of results and can apply modelling beyond the length of trial follow up. It is common to also link to administrative costing data such as Hospital or Medicare data which also provides opportunity for longer term follow up of resulting health service utilisation. Economic evaluation adds to the publication output and can provide meaningful results even in the event of unsuccessful clinical outcomes or trials stopped early.

The Centre for Health Policy kindly provides a sample of free resources and advice which can be accessed here.  

Through PTNA the University of Melbourne can also offer discounts on Health Economics short courses. Click here for the short course brochure which includes courses such as:

  • Introduction to Cost-Effectiveness Analysis in Health
  • Designing Economic Evaluation Alongside Clinical Studies 
  • Practical Methods for Health Economic Evaluation 
  • Incorporating Health Economics into Grant Proposals

Clinical Epidemiology & Biostatistics

Clinical Epidemiology & Biostatistics (CEBU) at MCRI in association with the Melbourne Children’s Trials Centre specialises in biostatistics, epidemiological methods and data management. Experienced biostatisticians are not only essential for developing sample size estimates and analysis plans but also invariably provide valuable input into many aspects of trial design and conduct, based on the wide range of trials experience that they have typically had. Modern clinical trial teams are expected to include professional statistical expertise.

What can CEBU help with?

  • development and refinement of your research question
  • study design
  • sample size calculations
  • protocol development
  • questionnaire design
  • database design for data capture
  • data capture and cleaning
  • randomisation
  • analysis planning
  • statistical analysis
  • presentation and writing up of results

CEBU also offers a range of short courses and training in these areas (with no prior knowledge required):

  • Introduction to Biostatistics 
  • Research Data Management 
  • Data Management in Action 
  • Stata I and II – (2-day courses)

For further information about how CEBU can support your investigator-led clinical trial or to register for a short course or training please contact CEBU.  

Protocol Templates

Murdoch Children’s Research Institute (MCRI) currently has two protocol templates and other useful research templates including toolkits available for your next study which is accessible via research resources 

In addition, the US National Institute for Health has an e-protocol whcih you can use to collaboratively write your protocol by assigning it to colleagues to write specific sections.  You can also track its progress, set up email alerts to review sections and export the document. Find the e-protocol resource here.