Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors
Data sharing: A new editorial initiative of the International Committee of Medical Journal Editors
Implications for the Editors' Network 0 1
F. Alfonso 0 1
0 Department of Cardiology, Hospital Universitario de La Princesa, Instituto de Investigacio?n Sanitaria IIS-IP, Universidad Auto?noma de Madrid , Madrid , Spain
1 This is a joint simultaneous publication initiative involving all interested National and Affiliated Cardiovascular Journals of the European Society of Cardiology. F. Alfonso is Chairman of Editors' Network. On behalf of the Editors' Network European Society of Cardiology Task Force; see Appendix for affiliations
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasising the importance of responsibility and accountability - have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Editorial ethics; Scientific process; Data sharing; Clinical trial; Trial registration; Authorship; Conflict of interest; Big-data; Scientific journals
The Editors? Network of the European Society of
Cardiology (ESC) is committed to promoting the implementation
of high-quality editorial standards among ESC National
Societies Cardiovascular Journals (NSCJ) [1?4]. NSCJ play
a major role in disseminating high-quality scientific
research. However, they also play a relevant role in
education and harmonisation of clinical practice . Most NSCJ
are published in local languages, but many have English
editions and have gained international scientific recognition
[1?4]. NSCJ complement well the official ESC journals and,
altogether, provide an effective means to disseminate
European cardiovascular research. In a globalised and highly
competitive editorial environment, promoting high-quality
editorial standards remains of paramount importance to
increase the scientific prestige of NSCJ [1?4]. From its
conception, the Editors? Network strongly advocated for
adherence to the uniform recommendations of the
International Committee of Medical Journal Editors (ICMJE) .
In its mission statement document the Editors? Network
committed to adapt NSCJ to follow these general editorial
recommendations . However, NSCJ are highly
heterogeneous in scope and contents and these new
recommendations should be embraced progressively, considering
currently existing editorial policies and the editorial freedom
of the NSCJ [1?4].
Ethical issues play a growing role in ensuring the
credibility of the scientific process [5?13]. Biomedical research
relies on trust. However, transparency also represents a
major tenet in the scientific process [5?8]. This review will
discuss the new editorial recommendations on data sharing
issued by the ICMJE . Novel ICMJE recommendations
always appear as provocative, and often as too ambitious,
when initially presented. Moreover, implementation of
editorial changes is rather demanding from a technical and
logistical viewpoint. Adherence to novel editorial
initiatives is challenging not only for editors, but also for the
entire scientific community. Therefore, many editors have
a natural tendency to avoid stepping ahead as early adopters
of new ?editorial experiments? and usually prefer to keep
moving within their comfort zone until the ?sea change?
has matured [1?4]. However, experience has taught us that
all editorial initiatives developed by the ICMJE eventually
prevailed and played a critical role in maintaining the
credibility of the scientific process [9?13]. Highly successful
recent examples include trial registration, a conflicts of
interest initiative and the new requirements for authorship
The novel ICMJE recommendations on data sharing 
are discussed herein from a didactic perspective with the
aim to provide new editorial insights and, hopefully, to be
progressively adopted and implemented by the NSCJ.
The ICMJE considers that there is a moral obligation to
responsibly share the data generated by clinical trials .
The rationale underlying this global endeavour is that
patients have assumed a risk by accepting to participate in
a trial. Accordingly, making the obtained data publicly
available represents a responsible initiative to facilitate the
advancement of science. Sharing the data would increase
trust in the conclusions reached by trials. Indeed, data
sharing allows confirmation of the results by independent
research . Furthermore, new hypotheses may be
pursued by different groups of investigators. This initiative
may foster the leveraging of data to answer different
research questions not contemplated in the original study. If
science becomes an open process, then many researchers
would benefit by taking advantage of reliable data
generated somewhere else. Therefore, data sharing emerges as
the best way to ensure that all the information gathered by
trials is made freely and widely available, so that it can
be readily used to advance scientific knowledge . The
use of previously collected data to further advance science
is difficult to criticise. As discussed, this honours the
volunteerism of the patients who signed up and consented to
participate in a trial.
Governments, funding agencies, scientific societies, the
industry and even the lay society growingly demand
sharing clinical trial data. Therefore, the ICMJE suggests that
editors should help to meet this ethical obligation by
devising new editorial policies specifically addressing this issue
. Proponents of ?open science? should be pleased by
this new editorial requirement of sharing clinical trial data
The first consideration is to clarify what a clinical trial is
exactly. According to the ICMJE definition, a clinical trial is
a study that prospectively assigns people to an intervention
in order to assess the cause-and-effect relationship between
that intervention and the ensuing health outcome .
The ICMJE considers that sharing ?de-identified?
individual patient data should become part of the publication
process of clinical trials . This strategy protects
patient?s confidentiality rights. The requirement, however, is
restricted to the individual-patient data underpinning the
results presented in the published article. Importantly, a clear
plan for data sharing should be disclosed at the time of
initial trial registration and should be also presented at the
time of manuscript submission. The proposal requires
clinical trialists to declare that they will share their data
publically as a prerequisite for publishing the trial . They
should promise to freely release individual patient raw data
at the time they submit the manuscript for consideration.
It is important to keep in mind that clinical trial
registration was a previous ICMJE editorial initiative aimed
to address problems related to publication bias (selective
publication of positive trials), endpoints inconsistency and
redundant research [9, 10]. Potentially, public repositories
provide an optimal tool not only for initial trial registration
but also for individual-patient data sharing. From now on
the plan for data sharing would be an important step of the
clinical trial registration initiative [9, 10, 14]. Details on
whether the data would be freely available upon request, or
only after a formal application that eventually will be
approved after an agreement is reached on data use conditions,
should be presented. Finally, it has been proposed that the
data should be made public no more than 6 months after
publication of the original study in the journal [9, 10, 14].
Clinicaltrials.com, a widely used non-for profit scientific
repository [9, 10], has already adapted its registration
platform to specifically clarify data-sharing plans at the time of
clinical trial registration.
Obviously, this editorial initiative may have profound
consequences on the planning, conduction and reporting of
clinical trials and, in fact, may deeply influence research
and publication strategies . As a result, the idea is to
implement this requirement for any clinical trial that
begins to enrol patients 1 year after the official adoption of
this editorial policy by the corresponding journal . The
initiative will also have major implications for the editorial
process. Indeed, editors are supposed to monitor the
datasharing process and, eventually, address potential
irregularities. These might include requests of clarification to the
authors, notification to academic institutions, publication of
expressions of concern or even retractions.
Finally, the ICJME acknowledges that the rights of the
investigators and sponsors should be protected .
Moreover, credit to the original report should be granted by
including a unique identifier of the dataset. It is emphasised
that credit should be always given to the original
investigators that posted the data after publication of their research.
Furthermore, additional investigators using these databases
should request collaboration of the investigators that
originally collected the data to ensure adequate data
interpretation, management and analysis.
Challenges of data sharing
Although it appears clear that this initiative will further
improve transparency and the overall integrity of the
scientific literature, some remaining issues need to be addressed.
There is inherent resistance to embrace open science
initiatives from some academic institutions or investigators that
defend the idea of exploiting their ?own? data [15, 16].
Until now clinical researchers were discouraged from working
with clinical trial data they did not generate themselves
[15, 16]. Likewise, trialists tended to see trial data as their
personal property and would routinely refuse requests for
data sharing. In fact, until very recently most researchers
and pharmaceutical industry groups were opposed to
making raw data available after trial publication. This practice,
however, differs from other disciplines (such as genomics
or economics) where data sharing has been common place
for a long time [15, 16].
Obtaining reliable, high-quality original data requires
a major research effort. Allowing a sufficient period of time
from the time of article publication to the need to share the
raw data would give original investigators the possibility
of publishing additional subgroup analyses from their own
data . This new proposal will further increase the
pressure on academic investigators that frequently do not have
the required resources to publish their subsequent analyses
and require time to prepare the new manuscripts .
Notably, most researchers have no experience with the process
of releasing or dealing with public data. Furthermore, the
effort and resources required to organise the raw data in
a way that would be comprehensible to other investigators
remain a cause of major concern . This would require
technical support and adequate funding.
Data access to non-trial researchers may disclose
problems not recognised by the initial investigators. Although
this will increase transparency and, therefore, trust in trial
results, it might also generate confusion and undue
scientific controversies. It is difficult to envision how the new
researchers will gain the required detailed knowledge of
the complicated datasets enjoyed by the original trial
investigators . A reliable assessment of the data requires
a deep knowledge on the study background and to be able
to properly address many nuances and practical
considerations. These include precise information on the way
variables were defined, how data was collected and how results
were finally coded and entered into the database. The
initiative might be fraught with problems related to incorrect
analysis resulting in inaccurate results and erroneous
interpretations, potentially damaging science .
Finally, editors, already deluged with work, will need to
check that all of the raw data of the published articles have
eventually been released as promised. Different results may
emerge from misconceptions regarding what data should
be analysed to answer specific questions . If there are
differences in results, it will be difficult to decide which
analysis provides the most accurate reflection of the data.
This could generate undue ?scientific noise?, with
contradictory results and rectifications, which may generate
confusion and frustration in the scientific community. Finally,
this may also promote the simultaneous publication in
several journals of conflicting results from the same database
by different groups .
As many issues should still be clarified, the ICMJE asked
for feedback on its preliminary editorial proposal on
clinical trial data sharing . Obviously, the initiative will
only gain the required maturity from the experience gained
during its adoption and implementation.
Previous initiatives on data sharing
Several leading academic entities have previously worked
in this field. The British Medical Journal pioneered an
editorial initiative of data sharing . In 2012 this policy took
effect only for trials on drugs and devices but, in 2015, the
requirement of data sharing ?on request? was extended to
all submitted clinical trials . It has been proposed that
individual patient data may also be of major value during
the ?peer review? process by permitting independent
verification of the results before final publication . Although
this initiative might be of potential value most reviewers are
already deluged with work and this extra task could
generate fatigue and burn out phenomena. In addition, many
good clinical reviewers do not have the expertise required
to manage data and to perform confirmatory statistical
analyses . Some journals, such as JAMA, previously
developed some related editorial initiatives including the request
for independent statistical analyses by an academic
statistician of industry-sponsored trials .
The World Health Organisation (WHO) and the Institute
of Medicine (IOM) previously made important declarations
on clinical trial transparency. In this regard, the IOM
issued specific guidelines for trial data sharing . WHO
initially presented a statement on public disclosure of
clinical trial results and, subsequently, encouraged sharing of
research datasets whenever appropriate [21?23]. More
recently, the WHO developed global norms for sharing data
and results during public health emergencies, with special
focus on clinical, epidemiological, and genetic features of
new infectious diseases and experimental therapeutics and
vaccines. In emergency situations, data need to be shared
quickly before the information is formally published .
Finally, the National Health, Lung and Blood Institute
(NHLBI) presented detailed data-sharing practices
allowing public access to trial raw data and developed a data
repository currently including over half a million patients
from over 100 trials and observational studies . In 2015
the NHLBI discussed its intent to make public the digital
data from its funded trials .
Platforms and repositories
Up to 30,000 clinical trials are conducted annually
worldwide generating a huge volume of patient-level raw data
. Currently, however, available portals for data sharing
are still not adequate. Most of them require a
time-consuming request, including a detailed research proposal with
the study design, main endpoints and a statistical plan .
The submitted proposal is then reviewed by an independent
research panel that decides whether to approve the request
for data [21, 25, 26]. Currently, this process takes too long
and when the data are eventually obtained oftentimes they
are not readily usable . However, the means to facilitate
data sharing from the data holder to the researcher may be
cumbersome and challenging to implement. Some systems
provide an electronic form or template . Nevertheless,
when these are not available a ?de novo? proposal should
be generated outlining the purpose, the statistical analysis
plan, the research team, and potential conflicts of interest.
The review process may come from an internal or external
review panel selected by the data holder or by a third party
[25?27]. Finally, data can be shared through a public
website or by direct communication between the data holder and
the researcher. In most cases, however, controlled access is
required. Before any analysis is started reviewing all the
accompanying documentation to assist the researcher in the
understanding of the original clinical trial and the
methodology used, remains critical. Furthermore, the data holder
may require a legally binding data-sharing agreement and
should be available to provide the required support should
questions arise .
Major care should be taken to prevent the perils that
may undermine the value of data sharing . Data from
trials should be responsibly used . A recent survey from
UK Clinical Trial Units disclosed some potential risks
associated with data sharing . These basically included
a) misuse of data, b) incorrect secondary analyses, c)
resource requirements and d) identification of patients [29,
30]. Researchers are responsible for presenting the data in
a format amenable for external secondary use.
Repositories should be prepared to make raw data available in
standardised platforms in a fully comprehensive manner. Data
sharing from trials with anonymised patient-level data with
associated metadata and supporting information should be
made available to other researchers following an
independent analysis of the research proposals. Developing and
adopting standard approaches to protecting patient privacy
are urgently required . Finally, an adequate
infrastructure should be organised to support effective data sharing.
In this regard, the role of the industry is significantly
growing as demonstrated by some joint initiatives, such as the
Yale University Open Data (YODA) project [16, 31].
Some academic research organisation consortiums
particularly focussed on the study of cardiovascular diseases
 have developed interesting tools for data sharing. This
cardiovascular initiative requires presentation of a
standardised request in a Web portal. Proposals are to be analysed
by a scientific committee, including members designated by
the consortium and a statistician along with the trial?s
principal investigator. The idea is to ensure an adequate use of
the database and correct statistical analyses, while averting
the problem of multiple investigators proposing the same
Statisticians play a key role in developing data-sharing
strategies . They should be involved from the very
beginning to organise the research strategy and the required
analytical techniques . In this scenario statisticians
should move from their classical role as data ?gatekeepers?
to that of data ?facilitators? . A data-sharing working
group of medical research statisticians has recently been
created from the pharmaceutical and biotechnological
industry and from academia. The idea was to address the
technical and statistical challenges of accessing research
data for re-analyses. Specific techniques are required to
ensure adequate data manipulation to convert the data
initially collected and entered in the data base into data that is
analytically usable. Converting raw data into standardised
formats may be challenging. Moreover, familiarity with
the required statistical programing language is necessary.
Independent statisticians should play a major role in
guiding the principles of re-analysis based on the researchers?
request while, at the same time, guarding against
misleading conclusions. They should be fully aware that additional
analysis may yield different results compared with the
original analyses. Accordingly, they should be prepared to
face criticism but, at the same time, they should be able to
openly challenge previous statistical methods .
Statistical guidance may be required for appropriate
interpretation of results from re-analyses where different
methods have been utilised. In particular, it is important
to keep in mind the inherent risk of over-interpretation of
the results from multiple subgroup analyses . Likewise,
documents for best practices in data anonymisation have
been developed . Statisticians should also be
familiar with this methodology. Risk to patient privacy can be
mitigated by data reduction techniques. Data holders are
responsible for generating de-identified datasets to offer
protection for patient privacy through masking or
generalisation of main identifiers. In addition, legally binding
data-sharing agreements should include a compromise not
to attempt to identify patients . In particular, it is
recommended that data use agreements are signed by the
data holder and researchers. Only appropriately qualified
?named? researchers should be granted access to the data.
Finally, high security levels should be implemented for data
transferring. Resources, costs and effort required to make
patient-level data available for third party research may be
considerable and, therefore, adequate funding should be
Credit to the original authors
A clear motivation for researchers to conduct randomised
clinical trials is the opportunity to publish different
studies in addition to the main manuscript with the primary
endpoint. These secondary analyses may be of major value
to unravel new findings from the original dataset [35, 36].
Many have proposed that the time to open the process of
data sharing should be extended to 2 years, or even to
5 years in selected complex or large studies. This will allow
precious time for the original investigators to further
scrutinise and analyse in depth their own data. As blinding is
necessary during trial execution, once the study is completed
the research teams concentrate on publishing the primary
findings as soon as possible. Following this, there is usually
a series of pre-planned additional analyses. These studies
are organised by collaborative research teams from different
institutions, but usually with relatively poor support.
Secondary analyses are also very important for co-investigators
and junior scientists. To respect this legitimate interest an
extension from the 6-month period after the primary data
have been published has been advocated [35, 36].
Academia rewards scientists with recognition for
making their discoveries public. Credit should be granted to the
original researchers that create datasets which other
investigators find useful [14, 15]. Otherwise, original investigators
may be tempted to consider those performing secondary
analyses of their data as ?research parasites?. Furthermore,
mechanisms are required to ensure that the external
analyses are conducted adequately and not merely to undermine
the original findings. Direct collaboration between primary
and secondary researchers is, therefore, necessary to ensure
proper data analysis and interpretation [14, 15]. The
original investigators who designed and conducted the trial and
obtained sources of funding deserve to receive adequate
scientific credit .
The data transparency revolution is here to stay. This is just
another step ahead into a culture of ?open science? and it
is clear that we are at the dawn of a new age [37, 38].
Several European National Societies have already
developed registry programs in which the registry databases are
public for the use of their members . Major challenges
and hurdles in the adoption and implementation of the new
ICMJE recommendation should still be overcome .
Experience gained by leading journals will eventually allow
a balanced compromise between the interests of the original
researchers and that of the scientific community as a whole.
NSCJ should progressively adapt their policies to increase
awareness of the importance of data sharing and promote
policies designed to enhance transparency in biomedical
Acknowledgements We are grateful for the support and assistance of
Ismahen Ouertani and Michael Alexander from the ESC Publications
Department at the European Heart House.
Conflict of interest F. Alfonso and none of the editors or authors of
this paper has any potential conflict of interest that needs to be
disclosed in relation to this manuscript.
Open Access This article is distributed under the terms of the
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creativecommons.org/licenses/by/4.0/), which permits unrestricted
use, distribution, and reproduction in any medium, provided you give
appropriate credit to the original author(s) and the source, provide a
link to the Creative Commons license, and indicate if changes were
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