http://www.fao.org/about/meetings/wgs-on-food-safety-management/en/ Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies. Presentation from the Technical Meeting on the impact of Whole Genome Sequencing (WGS) on food safety management and GMI-9, 23-25 May 2016, Rome, Italy.

1. Rome 25 May, 20161 |
Dr. C.E. Roth
Health Systems and Innovation Cluster
WHO Geneva
GMI9 2016
Future Health Challenges:
Developing Global Norms for
Data and Results Sharing during
Public Health Emergencies

2. Rome 25 May, 20162 |
Control of EIDs requires acceleration
of research
•Outbreaks of severe EIDs frequent, but
advances in knowledge for improvement of
tools for control are slow
•The only opportunity to fully evaluate new
diagnostics, vaccines and drugs, is during an
outbreak
•The only opportunity to implement and
validate public health measures is during an
outbreak

3. Rome 25 May, 20163 |
Underpinning the acceleration of
R&D - Data sharing
Early and open sharing of data and results for:
– Rapid sharing of findings to improve public health
practice (and save lives)
– Rapid sharing to accelerate the extension of
knowledge
– Impediments from concerns about publication,
recognition, proprietary issues
– Ethical considerations fundamental to data sharing
practices

4. Rome 25 May, 20164 |
What have we learned?

5. Rome 25 May, 20165 |
Dissemination bias has major adverse consequences.
Withholding results may:
• Be unethical by subjecting future experimental subjects to
unnecessary risk.
• May cause failure to apply life-protective measures during a
response
• Delay the acquisition of important knowledge
• Lead to inefficiencies in resource allocation for research and
development, and for financing of appropriate health
interventions.
• Create indirect costs for public and private entities, including
patients themselves, who pay for suboptimal or harmful
treatments.
• Potentially distort regulatory and public health decision making
The adverse consequences of non-
disclosure of results

6. Rome 25 May, 20166 |
Massive non-reporting is confirmed: incentives
and legislation are needed to fix the system
299, 763 participants enrolled in unpublished trials,
median 60 months after study completion
29% of all large clinical trials remained unpublished

7. Rome 25 May, 20167 |
Massive non-reporting is confirmed: incentives and
enforced legislation are needed to fix the system
MARCH 2015: Restricting analysis to
trials legally required to be disclosed
according to FDAAA

8. Rome 25 May, 20168 |
Obstacles to early data-sharing
•Fear of impediments to publication;
•Concern about recognition or stealing of
data;
• Inconclusive studies and "negative"
results;
•Proprietary issues
•Ethics concerns

9. Rome 25 May, 20169 |
•Epidemiological/surveillance data
•Research data – raw and analysed
•QC’d interim results
•Final research results
•‘Negative’ and inconclusive results
What kind of data?

10. Rome 25 May, 201610 |

11. Rome 25 May, 201611 |
•Researchers and agencies working on outbreaks must
agree norms and standards which reward cooperation
in early data and results sharing, and
•Incentives and safeguards are needed to encourage
release of data into the public domain within days to
weeks when emergencies occur
•Ethical concerns: privacy must be respected. Non-
disclosure of key results can be unethical
•Leading journals are now ensuring that they are not an
impediment to expedited results sharing
•Changing the default from ‘opt-in’ to ’opt-out’
A need for international standards for data
sharing in emergencies

12. Rome 25 May, 201612 |
• Funders
• Medical Journals
• Investigators/researchers
• Commercial entities/manufacturers
• Governments
• Ethics committees
• Regulatory authorities
Key constituencies

13. Rome 25 May, 201613 |
Data Sharing
Updated ICJME Recommendations, 2015

14. Rome 25 May, 201614 |
Journals, funders, and governments promote
data-sharing for Zika
10 Feb 2016 Statement “Data Sharing on Zika”
Journal signatories will make all content concerning the Zika virus free to access. Any
data or preprint deposited for unrestricted dissemination ahead of submission of any
paper will not pre-empt its publication in these journals.
Funder signatories will require researchers undertaking work relevant to public health
emergencies to set in place mechanisms to share quality-assured interim and final
data as rapidly and widely as possible, including with public health and research
communities and the World Health Organisation.
We urge other organisations to make the same commitments.
This commitment is in line with the consensus statement agreed at a WHO expert
consultation on data sharing last year whereby researchers are expected to share data
at the earliest opportunity, once they are adequately controlled for release and
subject to any safeguards required to protect research participants and patients.

15. Rome 25 May, 201615 |
Issues Actions
Delays introduced by data
use agreements for
evaluation of interventions
before or during public
health emergencies.
Development of template data use
agreements that outline governing principles
for data sharing, benefits for those sharing
data, responsibilities of those using data,
and obligations to publicly disclose results of
data analyses within specified timeframes.
Non-disclosure of clinical
trial data related to R&D in
the context of public health
emergencies.
Funders to change wording in agreements
so that there is a requirement for expedited
information sharing of quality-controlled
interim results, as well as disclosure of final
results when available.
Call for public disclosure of existing results
from pre-clinical and clinical studies.
Clarified timeline inside and outside
emergencies

16. Rome 25 May, 201616 |
Issues Actions
Non-disclosure of
epidemiologic and other
data related to potential
public health emergencies
Agreements that default should be opting-in
to data and results sharing.
Non-disclosure of clinical
trial data related to R&D in
the context of public health
emergencies.
Funders to change wording in agreements
so that there is a requirement for expedited
information sharing of quality-controlled
interim results, as well as disclosure of final
results when available.
Call for public disclosure of existing results
from pre-clinical and clinical studies.
Clarified timeline inside and outside
emergencies

17. Rome 25 May, 201617 |
Issues Actions
Patchy public disclosure of
genome sequence data related to
emerging pathogens.
A framework of principles, to be
developed by the genome sequencing
community and WHO, for the rapid
sharing/public disclosure of genome
sequence data in future public health
emergencies.
Lack of awareness about pre-
publication data and results
sharing mechanisms
Internet sites that direct users to web
resources where information is shared
pre-publication; presentations and
statements at major meetings, other
mechs of dissemination

18. Rome 25 May, 201618 |
• Recognition that epidemiological data 'belong' to the countries
where they are generated, but there should be a shift towards
an opt-out policy for data sharing during public health
emergencies, instead of the current opt-in policy
• Affirmation now received from biomedical journals that not only
will investigators NOT be penalized for pre-publication sharing of
key information of public health importance, but that it will be
strongly encouraged – to be applied widely
• Contingencies from funders that sharing key data and results
prior to and during publication are required for disbursement of
funds
• Continued commitment from industry to make data publicly
available
Next steps - data