Data linkage is the bringing together of records from different data collections related to the same individual. It can be useful in the context of clinical trials in a number of ways, including:

• A less burdensome method of data collection for participants during a clinical trial
• Cost-effective medium to long term follow-up of clinical trial participants
• Measurement of healthcare use before and after an intervention to assist in effectiveness and health economic analysis
• Post-market surveillance of therapeutics

Australia has a national data linkage network, the Population Health Research Network (PHRN) that enables existing health data from around the nation to be brought together and made available for research purposes. To date, the PHRN infrastructure has been infrequently used by clinical trials researchers. ACTA and the PHRN have developed this series of webinars to:

• Introduce clinical trial researchers to the PHRN facilities and services available
• Demonstrate the benefits of using linked data in clinical trials research
• Assist clinical trial researchers to design clinical trials using linked data and apply for access to linked data

We gratefully acknowledge support from the Australian Research Data Commons (ARDC) in delivering this project to you. This series consists of four sessions. The webinar content is outlined below.

• PHRN Data Linkage 1 - Designing CTs using Linked Data – Dr Felicity Flack Recording now available 
• PHRN Data Linkage 2 - Accessing Linked Data – Dr Felicity Flack Recording now available
• PHRN Data Linkage 3 - Ethical considerations – Dr Felicity Flack Recording now available 
• PHRN Data Linkage 4 – Accessing MBS/PBS data – Dr Anna Kemp-Casey Recording now available 

PHRN Data Linkage 1: Designing Clinical Trials using Linked Data Wednesday 20 March⋅1:00 – 2:00pm AEDT Recording now available Dr Felicity Flack  Objectives: By the end of this webinar participants should be able to:

• Name examples of administrative data collections available for linkage to clinical trials cohorts
• Identify the benefits and limitations of using linked administrative data in clinical trials
• Describe the main factors to take into account when designing a clinical trial using linked administrative data

Webinar Content: What is administrative data? Examples of administrative data available for linkage in Australia What are the benefits of using linked administrative data in clinical trials? Examples of what linked administrative data (Australian & international) can be used for e.g.

• Long term follow-up (all participants or only those lost to follow-up)
• Pre-recruitment hospitalisation as a measure of trajectory to care
• Measurement of healthcare use before and after an intervention
• Identification of eligible individuals or communities
• Economic analysis
• Aboriginal and Torres Strait Islander status

What are the limitations of using linked administrative data in clinical trials?

• Limited data items
• Limited data quality/validity information
• Limited metadata
• Linkage quality

Key points to consider when designing a clinical trial:

• Is the administrative data fit for purpose?
• What skills/experience will the research team require to analyse administrative data?
• Have the participants provided informed consent or are there grounds to apply for a waiver of consent?
• How will the data be cleaned, managed and kept secure?

Resources available

• Metadata
• Training courses
• Publications

PHRN Data Linkage 2: Accessing Linked Data Wednesday 27 March⋅1:00 – 2:00pm AEDT Recording now available    Dr Felicity Flack  Objectives: By the end of this webinar participants should be able to:

• Explain the three key steps in the data linkage process (separation, linkage and access)
• Name some of the data linkage services and facilities available
• Describe the 6 steps in the process to access linked administrative data
• Understand the current timelines and costs involved in accessing linked administrative data

Content: What is data linkage? Short animation of linkage process What linkage variables are required to link my clinical trials cohort to administrative data? Data linkage services and facilities in Australia

• State/Territory linkage units
• AIHW Data Linkage Unit
• Online Application System
• SURE
• SUFEX
• Metadata and other information available

What is the process for applying and receiving linked data?

• Study design
• Feasibility
• Data custodian approval
• Ethics approval
• Linkage
• Data extraction

PHRN Data Linkage 3: Ethical considerations in using Linked Data Wednesday 3 April⋅1:00 – 2:00pm AEDT Recording now available    Dr Felicity Flack Objectives: By the end of this webinar participants should be able to:

• Explain the key ethical issues related to accessing linked administrative data
• Describe the legal framework applicable to accessing linked administrative data without consent
• List some strategies to demonstrate respect in the absence of consent

Content: Access to linked data with consent

• Key ethical issues
• Participant information sheets and consent forms
• Data management

Access to linked data without consent

• Key ethical issues
• The legal framework
• The National Statement – Waiver of consent
• Privacy legislation
• Demonstrating respect in the absence of consent

PHRN Data Linkage 4: Accessing MBS and PBS data Wednesday 10 April⋅1:00 – 2:00pm AEST Recording now available    Dr Anna Kemp-Casey Objectives: By the end of this webinar participants should be able to:

• Give examples of how linked Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data can be used in clinical trials
• Describe the application process for access to linked MBS and PBS data with and without consent

Content: Description of MBS and PBS data collections including:

• Types of variables
• Coding of services and items
• Historical changes to item numbers and how to respond to these

Examples of research done using linked MBS and/or PBS data How to apply for MBS/PBS data

• With consent
• Without consent

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