clinical data publishing at scientific data

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

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