ANZCTR: Why we need better sharing of clinical trial data

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ANZCTRWhy we need better sharing of clinical trial dataPresented byAilsa LangfordANZCTR project officer

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The problem…

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Bias in clinical trials reporting

Selective reporting

Publication bias

Trials showing positive results are more likely to be published

Outcomes showing positive results with statistical significance are more likely to be

reported

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Graph from The Lancet series on research waste, ‘Increasing value, reducing waste 4’, using data from Ross et. al, 2012.

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COMPare project

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Implications

RESEARCH WASTE

Ethical implications

Healthcare policy

Resources

Patient care

Systematic reviews and

HTA

Clinical practice

guidelines

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Potential solutions:

1. Prospective clinical trial registration

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What is a Clinical Trials Registry?

An online publicly accessible registry

of clinical trials

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Trial registration

Retrospective

ProspectiveRegistered prior

to enrolment of first participant

Registered after enrolment of first

participant

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The importance of Clinical Trial RegistrationReduce biasEthical obligation ICMJE requirements for publicationFacilitate recruitmentAvoid duplication Identify research gapsPromote collaboration Improve trial qualityProvide sufficient detail for replication

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Primary Registries in WHO Registry Network

Other Registries

ANZ• Australian New Zealand Clinical

Trials RegistryAmericas• Cuban Public Registry of Clinical

Trials• Brazilian Clinical Trials RegistryAsia• Chinese Clinical Trial Register• Clinical Research Information

Service - Republic of Korea• Clinical Trials Registry - India• Sri Lanka Clinical Trials Registry• Japan Primary Registries Network • Thai Clinical Trials Registry• Iranian Registry of Clinical TrialsEurope• EU Clinical Trials Register• German Clinical Trials Register• ISRCTN.org• Netherlands National Trial RegisterAfrica• Pan African Clinical Trial Registry

Partner Registries in the WHO Registry Network:• Clinical Trial Registry of the

University Medical Center Freiburg

• DeReG - German Registry for Somatic Gene-Transfer Trials

• Centre for Clinical Trials, Clinical Trials Registry – Chinese University of Hong Kong

Other ICMJE recognised registries:• ClinicalTrials.gov

WHO ICTRP – A global registry network

All trials uploaded to the ICTRP search portal at:

www.who.int/trialsearch

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WHO Trial Registration Data Set

1. Primary register and trial ID2. Date of registration in primary register3. Secondary ID4. Source(s) of monetary or material support5. Primary sponsor(s)6. Secondary sponsor(s)7. Contact for public queries8. Contact for scientific queries9. Public title10.Scientific title11.Countries of recruitment12.Health condition(s) or problem(s) studied13.Intervention(s)14.Key inclusion & exclusion criteria15.Study type16.Date of first enrolment17.Target sample size18.Recruitment status19.Primary outcome20.Key secondary outcomes

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Clinical trial registration data

Other government bodies and research institutes

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www.anzctr.org.au

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www.who.int/trialsearch

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www.australianclinicaltrials.gov.au

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www.australiancancertrials.gov.au

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Potential solutions:

2. Results reporting

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Results reporting

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Registries - a platform for results reporting

Proposed fields:

– Intentions for publication• Protocol• Main results

– Participant level data

– Basic results summary

– Plain English summary

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Other future plans/solutions?

– Role for Ethics Committees

– Role for journal editors

– New ideas?

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Prospective trial

registration

Results reporting

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Any questions?

Thank you.