Presentation by Miranda Cumpston, ACTA, to the 'Unlocking value from publicly funded Clinical Research Data' workshop, cohosted by ARDC and CSIRO at ANU on 6 March 2019.

1. Miranda Cumpston
Senior Program Manager
Unlocking the value from publicly funded Clinical Research Data
Canberra, 6 March 2019
ACTA gratefully acknowledges operational funding from the
Australian Government’s Medical Research Future Fund
Investigator-initiated
clinical trials:
a community perspective

2. National peak body supporting and
representing investigator-initiated clinical trials
sector, including
• Clinical Trial Networks (CTNs)
• Clinical trial Coordinating Centres (CCs)
• Registries
That’s more than 10,000 clinician-researchers
Who is ACTA’s community?

3. ⟩ Profiling Networks
⟩ 10 years
⟩ > 1,000 studies
⟩ > 1 million participants
⟩ > $1 billion research funding
⟩ Substantive proportion of
NHMRC budget for clinical trials
CTNs in Australia

4. What do our trials look like?
• Investigator-initiated
• Focused on questions in current practice
• Clinicians, not all with academic roles
• Increasingly multi-site or multinational
• Outcome data
• Collected for the trial OR routine data collection
• Novel designs
• Adaptive and platform trials
• Funding
• For trials: grants, occasional industry collaboration
• For networks: varies, but often limited

5. How do trialists feel about ‘unlocking’ trials
I want my trial
to impact
health
(but I have questions
about process)
I want to
access linked
data from
other
datasets
I’m already
working on
re-use
projects!
I’m not sure
about this…

6. AHMAC: 3 functions of the healthcare system
Health
care
ResearchEducation
ACTA: It follows that healthcare
improvement is a primary purpose of
research data collected within the
healthcare system

7. It’s already happening
• Networks already respond to requests to manually share data
• ICMJE requires data sharing statement
• NHMRC “strongly encourages researchers to take reasonable steps to share research
data and associated metadata”
• Trials conducted in Australia are also subject to international funding and laws
• Data from Australian trial participants already being shared

8. What process issues should be addressed?
• Privacy/data protection
• Participant consent
• New trials, trials already commenced
• Opt-in, opt-out, waived
• Opportunities for future research
• IP and acknowledgement for subsequent research outputs
• Competition with better resourced groups
• Commercial groups with conflict of interest
• Funding/resources for data preparation and sharing
• Cleaning, derived variables, variable names, data dictionary, etc.
• Technical knowledge/capacity to implement
• Standards, platforms, integration/APIs with existing applications

9. None of these issues is insurmountable
…some have been solved already
• Shared decisions about acceptable practice around ethics and data protection
• Standards for minimum datasets, meta-data, ontologies, endpoints, etc.
• Technical solutions to FAIR principles
• Resource solutions: who, when, how
• Implementation: so sharing and re-use will both happen

10. Thank you