clinical data publishing at scientific data
TRANSCRIPT
Varsha Khodiyar, PhD
Data Curation Editor, Scientific DataNature Publishing Group
@varsha_khodiyar
@scientificdata
Clinical Data Publishing at Scientific Data
Health Data IG, 1st March 2016
2
www.nature.com/scientificdata
Data Descriptors have human and machine readable components
3
Human readable representation of
studyi.e. article (HTML &
PDF)
Human readable representation of
studyi.e. article (HTML
& PDF)
Machine readable
representation of study
i.e. metadata
SynthesisAnalysisConclusions
What did I do to generate the data?How was the data processed?Where is the data?Who did what and when?
Methods and technical analyses supporting the quality of the measurements.Do not contain tests of new scientific hypotheses
Comparison of Data Descriptor to traditional article
Clinical researchers support sharing, but…
Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS: Sharing of clinical trial data among trialists: a cross sectional survey. BMJ 2012;345:e7570
• Sharing de-identified data via repositories should be required (236 respondents, 74%)
• Investigators should share de-identified data on request (229 respondents, 72%)
…clinical data producers have specific concerns
Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS: Sharing of clinical trial data among trialists: a cross sectional survey. BMJ 2012;345:e7570
Example initiatives for sharing clinical data
Yale Open Data Access (YODA) & Clinical Study Data Request (CSDR) projects:
• Data Use Agreements (DUAs)• Controlled access environment• Scientific validity of reanalysis checked• Independent governance• Data anonymisation checks
http://yoda.yale.edu/https://www.clinicalstudydatarequest.com/
Clinical data publication at Scientific Data
• Identify repositories able to archive clinical data
• Work with identified repositories to establish workflows for
peer review and publication, whilst maintaining patient
privacy
• Facilitate specialist peer review process for clinical data, for
example ensure peer reviewers have agreed to terms of data
use agreement
A robust data-on-request workflow?
Hrynaszkiewicz, I., Khodiyar, V., Hufton, A. & Sansone, S. A. Publishing descriptions of non-public clinical datasets: guidance for researchers, repositories, editors and funding organisations. BioRxiv http://dx.doi.org/10.1101/021667 (2015).
Published Data Descriptor with clinical dataData Records
section details how to access
the data
Links to restricted access data Data Citations link to repository
Data files requiring
permission to access
Freely accessible data files
Get more from
your data
Preserve it
Encourage reuse
Get credit for it
Visit nature.com/sdataEmail [email protected] @ScientificData #SDJPN16