5 minute presentation given at RDA P7 at the Health Data IG session.

1. Varsha Khodiyar, PhD
Data Curation Editor, Scientific Data
Nature Publishing Group
@varsha_khodiyar
@scientificdata
Clinical Data Publishing at Scientific Data
Health Data IG, 1st March 2016

2. 2
www.nature.com/scientificdata

3. Data Descriptors have human and machine readable
components
3
Human readable
representation of
study
i.e. article (HTML &
PDF)
Human readable
representation of
study
i.e. article (HTML
& PDF)
Machine
readable
representation
of study
i.e. metadata

4. Synthesis
Analysis
Conclusions
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

5. 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%)

6. …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

7. 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/

8. 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

9. 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).

10. Published Data Descriptor with clinical data
Data Records
section details
how to access
the data

11. Links to restricted access data Data
Citations link
to repository
Data files
requiring
permission
to access
Freely
accessible
data files

12. Get more
from
your data
Preserve
it
Encourage
reuse
Get credit
for it
Visit nature.com/sdata
Email scientificdata@nature.com
Tweet @ScientificData #SDJPN16