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Dr. C.E. RothHealth Systems and Innovation ClusterWHO Geneva

GMI9 2016

Future Health Challenges: Developing Global Norms for Data and Results Sharing during Public Health Emergencies

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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

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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

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What have we learned?

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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

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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299, 763 participants enrolled in unpublished trials,

median 60 months after study completion29% of all large clinical trials remained unpublished

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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

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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

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•Epidemiological/surveillance data

•Research data – raw and analysed

•QC’d interim results

•Final research results

•‘Negative’ and inconclusive results

What kind of data?

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•Researchers and agencies working on outbreaks must agree norms and standards which reward cooperationin 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

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• Funders

• Medical Journals

• Investigators/researchers

• Commercial entities/manufacturers

• Governments

• Ethics committees

• Regulatory authorities

Key constituencies

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Data SharingUpdated ICJME Recommendations, 2015

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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.

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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

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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

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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

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• 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