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Karmela Krlea - Jeri No conflict of interest but interest in research & public disclosure of research data KKJ 2019 I am Consumer advocate - member CCNET Consumer coordinator Croatian Cochrane Study participant MD, D.Sc

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Karmela Krleža-Jerić

No conflict of interest but interest in research & public disclosure of research data

KKJ 2019

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I am

  • Consumer advocate - member CCNET
  • Consumer coordinator Croatian Cochrane
  • Study participant
  • MD, D.Sc
  • Researcher
  • Visiting scientist @ MedILS and Visiting scholar @

EHIL

KKJ 2019

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Memento – Hippocrates

…and I will use regimens for the benefit of the ill in accordance with my ability and my judgment, but I will keep from them those that might harm them. The health of my patient will be my first consideration….

KKJ 2019

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part 2

  • IMPACT Observatory and what we learned from

its studies

  • Privacy and anonymization
  • Inspire

▪ thinking on how to get responsible, efficient, research

that would give trustworthy evidence

▪ joining the IMPACT Observatory network

KKJ 2019

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Poll 1

Please define yourself: (Yes/No- check all that apply)

1. Patient (someone with a personal experience of a health condition) 2. Care giver 3. Member (volunteer or paid) of health related associations, including NGOs & patient org 4. Decision maker 5. Health professional

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Open access to trial data

  • Prospective trial registration and public disclosure
  • f results , data and all related documents
  • culture, initiatives, actions, shift of paradigm
  • define how-what-where-use

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IMPACT Observatory

IMProving Access to Clinical Trial data - IMPACT Observatory

  • f
  • ngoing transition in clinical research regarding data sharing;
  • pportunities and barriers

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Observatories or natural experiments are epidemiological studies that

  • assess the impact of one or several interventions

that are not controlled by the observatory researcher(s)

  • to inform the process and indicate trends.

IMPACT Observatory: multiple players act on CT data sharing with a consequent impact on the CT enterprise.

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IMPACT OBSERVATORY

KKJ 2019 impact the transition

  • f data sharing & of

research indicate potential trends; suggest improvements assess barriers, gaps and opportunities of

  • pening clinical trial

data identify changes of culture, perceptions policies and practice; dynamics and roles of players

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IMPACT Observatory story

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2004 2006 2008 2012 2013 2014

Trial registration standards Ottawa (CIHR-IRSC) Ottawa (British High Commission, University of Ottawa, participants) NewFelPro Fellowship

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IMPACT Observatory

Aims to

  • assess transition of data sharing
  • increase

▪

reliability of evidence

▪

research integrity

▪

quality of studies

  • contribute to

▪

speeding knowledge creation – innovations- health interventions

▪

  • vercoming research waste

▪

avoiding unnecessary & harmful trials

▪

regaining public trust

  • indicate trends – inform- impact transition
  • contribute to health

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Changes

▪

culture of researchers regarding

  • data sharing
  • research of existing data

▪

policies of

  • regulators
  • funders
  • journals
  • pharmaceutical industry (pharma)
  • academia

▪

standards

▪

initiatives and projects regarding

  • access to data

▪

data repositories

  • features
  • policies
  • standards for data accepting, curatorship and sharing
  • partnership

▪

registries of repositories

  • features

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IMPACT Observatory challenges

  • Complex; numerous players; their culture,

actions & interactions

  • Build and maintain network
  • Connect the dots

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Researchers Regulators Funders Journals Publishers Pharmaceutical Industry Academia Consumer Advocates Media Repositories Policy Culture Infrastructure Access Preservation Knowhow

Issues and players

Decision Makers Patient Groups Standards Initiatives Findability Citability Librarians

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Barriers 2012-2019

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Potential development

IMPACT Observatory evolves in a long-term observatory and

  • Continues

▪ assessing data opening process until data is open

  • Contributes to

▪ data opening/access process ▪ change of the research paradigm ▪ refining methodology

  • Expands to other areas, test & adapt methodology as needed
  • Potential next steps:

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IMPACT Observatory of aging research

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Potential spin off

  • Identify analyzable IPD based data sets in selected

repositories and

  • Test re-usability of such data
  • Assess

▪ the extend data are shared and re-used ▪ the add on value of IPD meta-analysis

  • Contribute to standards development
  • Change of paradigm

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What is IMPACT Observatory

  • A tool, a Hub, virtual organisation

▪ assessing and informing about the opening of CT

data and related changes of research

▪ aiming at contributing to a change of the CT

paradigm due to data sharing changes

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Who is IMPACT Observatory

  • Multi nodal network & team of people/

groups of people with good ideas and a good will

  • We are - anyone interested in increasing

access to CT data

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Methodology

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Public release of findings

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Methodology

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Scoping review

A process of

  • Scanning & mapping literature and other

sources on a specific topic

  • identifying key concepts, theories, and

sources of evidence

  • aiming to better understanding phenomena

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Scoping review

  • Advantages:

▪ flexible

  • Challenges

▪ language –terms - translations ▪ no specific MESH terms ▪ Media , Social media

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BASELINE- KEY MILESTONES

Mahmić-Kaknjo M, Šimić J, Krleža-Jerić K. Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline. Biochem Med (Zagreb). 2018;28(1):010201.

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Ongoing Scoping review of CT data sharing in 21st Century

Croatian Cochrane Symposium Split, Croatia 2016

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access

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From: Krleža-Jerić K.et al. Observatory of trials data sharing as a tool to overcome waste-IMPACT Observatory, Poster; Reward Equator Conference; Increasing value and reducing waste in biomedical research conference. Edinburgh, 28-30 Sept, 2015 .

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Methodology

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Surveys and Interviews

Culture- perception-opinions-positions- policy- practice Interlinked –mutually informing Interviews are still going on

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Interviews

We analyzed one interview from each of six key constituencies/ players:

  • academia
  • consumer/study participant
  • editor
  • funder
  • pharma
  • researcher

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Interviews - key messages across

  • data should be shared but
  • data opening will take place gradually
  • international standards are essential; standards for anonymization, &

standards to prepare data for public release

  • standards should be developed by an independent international,

trustworthy organisation (such as WHO)

  • data should be in format that would enable their future use ie analysis;

consumer specified that they should be shared electronically, on the Internet.

  • data from publicly funded studies should be made publicly available

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Interviews

Change of culture Interviewee from academia:.”We have been telling

researchers that all their data is confidential, and they must not give it away and that they have to keep it secure and safe, and now we are trying to turn it around… and make data publicly available”

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Surveys of players

Internet/ WEB based surveys: Monkey and Qualtrics

  • Journals editors – WAME 2009: N=108 and 2015: n=

85

  • Clinician trialists 2015: N=2250
  • Consumers and patient groups:

▪ CCNet 2017: N=65 ▪ Italian patient and citizen organizations 2017: N=280 ▪ Croatian Cocharne Partner Organisations 2018: N=52

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None Summary protocol Full Protocol Summary results All results IPD Statistical code CSR All docs. Full financial

3.6% 57.7% 57.7% 57.7% 46.8% 32.4% 36.0% 40.5% 36.0% 64.0% 5.26% 61.40% 66.67% 59.65% 64.91% 40.35% 40.35% 47.37% 36.84% 63.16% 0.9% 48.7% 61.4% 56.0% 54.2% 26.5% 23.5% 24.9% 21.6% 57.7%

WAME CCNET Trialists

SURVEY COMPARISON: WHAT SHOULD BE PUBLICLY AVAILABLE

KKJ 2017

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TRIALIST SURVEY

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No, 53.3% Upon Request, 35.4% Yes, 11.3%

SHARED IPDS

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NEEDED FOR SHARING RAW DATA

Anonymization Data preparation methods Standards data sharing and reuse Repository standards Ethically verified researchers Registration needed Researchers guarantee not to identify Legal mechanisms to punish misuse Other

75% 70% 72% 68% 42% 56% 63% 68% 18%

NEEDED FOR SHARING RAW DATA

Anonymization Data preparation methods Standards data sharing and reuse Repository standards Ethically verified researchers Registration needed Researchers guarantee not to identify Legal mechanisms to punish misuse Other

75% 70% 72% 68% 42% 56% 63% 68% 18%

Very helpful

74%

Helpful

16%

Undecided

3%

Not so helpful

2%

Not at all helpful

2%

Other

3%

INTERNATIONAL STANDARDS

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CCNET SURVEY

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consumers on data sharing

Italian groups

  • reduce unnecessary

research

  • study adverse reactions

to treatments Croatian

  • transparency; the right

to know

  • assessment of errors
  • progress of science

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Poll 2

Did you ever participate in a clinical trial as (check all that apply) Study participant Member of the study team None of the above

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Anonymization

Anonymization needed for data sharing

Trialists (n=1804)– highly rated: 7.8 of 10 CCNET (n= 57) : 75% Italian (n=131): 66.4%

  • Also re-identification a risk (n-258): cca 50% but if

they knew about the IPD debate 61.6% vs 38.4% consider re-identification a risk

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Khaled privacy

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Poll 3:

Did you ever perform or participate in performing of (check all that apply)

  • 1. Systematic review
  • 2. Meta-analysis of aggregate data
  • 3. Meta analysis of IPD
  • 4. None of the above

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Methodology

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Initiatives

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CSDR DataSphere YODA VIVLI REPOSITORIES IOM ICMJE WHO FUNDERS REGULATORS OTTAWA STATEMENT ECRIN-CORBEL STUDY COCHRANE DOH FAIRSHARING bioCADDIE CTTI BIOGRID AUSTRALIA RESEARCH DATA AUSTRALIA

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Vivli YODA Project

Available trials requests

IPD

270

113

94.5%

CSDR

15 4

3000+

pharma Public funders Consortium trials

Platform Project Data Sphere

32

Data Providers

189

Datasets

2,213

Users Trials

3200+

Members

16

Countries

100

Platform

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How

  • establish partnership with data providers
  • investigators request - reviews

▪ independent scientific reviews ▪ data provider review ▪ data provider/company final approval

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Methodology

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Environmental scan of repositories

Objective

  • Identify and explore essential features and practices of repositories that
  • accept clinical trial data including IPD
  • facilitate their public disclosure

Use/ KT

  • Inform
  • Raise awareness
  • Help plan the future
  • Encourage collaboration btw repositories and other players

To achieve public disclosure of trial data and change of research paradigm

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2016-Collaboration/Participation

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Selection/inclusion criteria Search Data collection Analysis Reporting

Methodology

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Repositories in public domain that harvest clinical trial raw data with a goal of enabling sharing and public disclosure Internet Registries of repositories Re3data Literature

  • ther sources

Define features- develop headings in Excel Extract data from Internet/ re3data/ repository websites/ literature/ repository managers Coding Analysis Assessment Trends Presentations Conferences Internet - websites Publications

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Research Data Repositories

KKJ 2019

necessary to achieve the full transparency

  • f research
  • pen data

store and maintain data provide access to data archive enable share, reuse

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Challenges

  • Learning process select and exclude

▪ Platforms , Initiatives, Projects , Portals

  • Dynamic area - evolution of repositories

number and features

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58 headings in 6 sections

  • General (name, url, source)
  • Type of repository (academia, pharma, consortia, geo

coverage)

  • Data (who can upload, download, formats, citability)
  • Organisational framework ($, ownership, partnership)
  • Ethics
  • Architecture (GUI, Researcher to data environment,

query, social commentary, templates

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GENERAL

  • Name
  • URL
  • DOI
  • Re3data
  • Scientific Area
  • Geo-coverage

DATA FORMAT

  • SAS
  • SPSS
  • Stata Files
  • Non specific
  • Depends on data
  • as is
  • multiple formats to enable accessibility

CITABILITY OF DATA

  • DOI
  • URN
  • ARK
  • Handle
  • PURL
  • Persistent identifier system HDL
  • Repository/ registry ID
  • Unique Patient Number

DATA STANDARDS

  • No universal standards
  • Leave to submitter and journal
  • Range of standards
  • Defined
  • No specific
  • No specific fields
  • Any
  • As is

WHO CAN UPLOAD

  • Anyone
  • Anyone from a given county
  • Institution based
  • Collaborators of
  • Only if published

SECONDARY USE ACCESS

Open free to download & no legal barriers to reuse Limited /Restricted upon request qualified researcher Conditions data use agreement no sharing Closed responsible organisation only Combination

PARTNERSHIP

Journals /publishers Dryad- BMJ Figshare- PLoS, Faculty 1000 ORCID Funding agencies Governments Consortia Pharma-Academy Yoda-Medtronic

TYPE OF RESEARCH DATA

  • publications
  • any standard file
  • images, graphs, video
  • multimedia & audiovisual
  • datasets
  • utcome data
  • summary data
  • raw data
  • individual participant data
  • metadata

CONTROL OF QUALITY

At entrance:

Extensively curated at entrance To certain extend As is

Once in the repository:

heterogeneity maintenance curatorship

ARCHITECTURE

Query system GUI Online analysis Access data in situ vs download Report templates Social notification/ commentary Researcher to data interface Standards Data use agreements

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Repositories registered in re3data

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600 1275 1347 1415 2224 2300 Repositories May-13 Jun-15 Oct-15 Jan-16 Nov-18 Mar-19

29 host CT data: 14 general & 12 disease specific & 3 domain

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What we learned so far

  • Repository types

▪

Scientific area/ scope

  • General any research (14)
  • Disease specific (12)
  • Domain / Clinical trials repository (3)

▪

Geo coverage: Global– Regional – International - Country - Institutional

▪

Combination & evolution

  • RDA – Research Data Alliance

https://rd-alliance.org/repositories

  • Certificates

▪

CoreTrust Seal Certificate (WDS, DSA)

  • Repositories assign PID to data

sets

  • re3data registry of research

data repositories

  • DataCite manages re3data and assigns

DOI to repositories

  • re3data valuable source of info on

repositories

▪

but search issues- specific descriptors are needed

  • No universally accepted standards
  • Heterogeneity

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Repositories hosting CT data

16

REPOSITORIES

7

GLOBAL

7

OPEN ACCESS

4

INSTITUTIONAL

3

NATIONAL

1

REGIONAL

1

MULTINATIONAL

PID

14

5

CERTIFICATE

2

DOMAIN

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General Repositories hosting CT data 2019

KKJ 2019

ArrayExpress B2Share DRUM Dryad EASY Edinburg Datashare Figshare Harvard dataverse ICPSR LSHTM Data Compass University of Bath Res Data Archive OSF (Open Science Framework) SND Zenodo

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Domain repositories

Any Clinical trial Disease specific clinical trials

KKJ 2019

UMIN Clinical Trials Registry (UMIN-CTR)

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This environmental scan will

  • Inform development of methodologies and standards
  • Raise awareness
  • Encourage collaboration between
  • Repositories
  • Researchers, journals, publishers, and data repositories

to achieve public disclosure of trial data

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REPOSITORIES hosting CT data

  • Exist
  • Features keep improving
  • Domain repository shortage
  • Improvement and development needed

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Poll 4

Would you agree to participate in an online survey by IMPACT Observatory about this issue? Yes/No

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CONCLUSION

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Access to data will contribute to

▪

Research integrity

▪

Quality of studies

▪

Reducing

  • publication bias
  • waste

▪

Avoiding

  • unnecessary trials
  • harmful trials to be repeated

▪

Reliability of evidence

▪

Regaining public trust

▪

Knowledge creation

▪

Better diagnostics and therapies

▪

Health of people

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what we need to do to

increase transparency, knowledge sharing and knowledge translation?

  • Different players have

▪ different roles to play ▪ to collaborate

  • Develop international standards

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Trialist Moto

“Someone will use data I collected”

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Opening trial data

▪ Not there yet but on the way ▪ Important ▪ Barriers-Gaps- Issues ▪ Doable: what- how- ▪ Vision ▪ Change of culture

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IMPACT Observatory Next steps

  • Continue –assess and inform
  • Expand- implement- test the IMPACT

Observatory methodology in other areas

  • IMPACT Observatory of aging research;

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Contribution Collaboration Participation

krlezajk@hotmail.com

Invitation for

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Acknowledgment

  • IMPACT Observatory network
  • Ottawa group, PROCTOR and IMPACT initiatives
  • Committee on Publication Ethics (COPE) for funding the environmental scan
  • f repositories; research grant in 2012
  • fellowship for supporting the PI of the IMPACT Observatory in 2014
  • MedILS for hosting
  • Nevena Jeric, Apropo Media, for graphic solutions of the presentation

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APPENDIX

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Sharing the story - always in open access

  • Editorial in Periodicum Bilogorum: https://hrcak.srce.hr/138067
  • Publication in Biochemia Medica https://www.ncbi.nlm.nih.gov/pubmed/27812300
  • MedILS: http://www.medils.org/research/impact-observatory
  • Presented at conferences Newfelpro http://www.newfelpro.hr/default.aspx?id=1277
  • Workshop in Australia: https://openmq.com.au/course/IMPACT001
  • Figshare: https://figshare.com/authors/Karmela_Krleza-Jeric/98936

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Privacy- Anonymisation

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kkj-CIHR May 2008

Diving Into Clinical Trials

by Natalie Salat January/February 2007, 56-58.

https://legionmagazine.com/en/2007/01/diving-into-clinical-trials/

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IMPACT Observatory

as a Tool to Overcome WASTE

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