Over the last year, the New England Journal of Medicine has devoted much
time and thought to the topic of data sharing. We have published dozens of
articles from many different perspectives, viewing what the community
thinks about data sharing, and in April, we hosted a data summit that brought
together all of these constituencies so they could have an open and honest
dialogue. On Monday, the New England Journal of Medicine, along with members
of the International Committee of Medical Journal Editors, together
published a joint statement on data sharing. With me is Dr. Jeffrey Drazen,
the editor-in-chief of the New England Journal of Medicine, to describe what was
in the statement and what it means. [Dr. Drazen] So, the International Committee of medical
journal editors was founded over 40 years ago with the idea of providing
guidance for authors in the research community to enhance the reporting of
medical research. Over a year ago we published a statement
from the ICMJE, asking for comment on the possibility of
sharing data from clinical trials. We got a lot of comments from that, and, over the
year after we published the statement, we had a long discussion among the editors,
and yesterday we published an editorial saying that we will require a data
sharing statement when an article is submitted after July 1st 2018. The data
sharing statement is a statement of what the authors will do, that is, what data
will be shared, with whom, for what purpose, at what time, and by what means.
That statement will run with the article and will be, we hope, similar in all
journals so that people will be able to understand the ecology in the world
of data sharing. As of January 1st 2019, we're going to require that that similar
information be put in a data sharing plan that is filed at the same time as
any clinical trial that starts after January 1st 2019.
We realize that the data sharing plan may change from the time it's originally
launched till the time the research is published
from it, but the idea is for the investigators to think in advance about
what data they plan to share, with whom, for what purpose, and at what time. [Jen] Could
you describe a little bit more about some of the measures the ICMJE has
taken to enhance the reporting of clinical data? [Dr. Drazen] So the journal editors
have gotten together to help make uniform the reporting of clinical trials and
medical research in general. We have statements about authorship, but our
probably most impactful statement was made in September of 2004, when we said
that any clinical trial that was initiated after September of 2005 had to
be registered in the database. And although there was some community uproar
at the time we made the statement, a year later
most entities complied and now registering your clinical trial at the time
of inception is common. So moving forward, to data individual patient data sharing
is part of this ecology. We're trying to improve the ecology of clinical trials
reporting so that we can honor the commitment made by the people who were
in the clinical trials. [Jen] One of the big things that came out at the data summit
in April was that everyone -- a lot of the community, especially the patients -- were
saying open the data right now. What do you say to those who think that this
doesn't go far enough, fast enough? [Dr. Drazen] So we think that eventually we'll probably be
there, but the infrastructure to allow people to report data is not easy to
build and it's not inexpensive, and frankly doesn't exist. So we can't
require people to use something that doesn't exist, so our dates are into the
future. January of 2019 is when we're going to be requiring that a data
sharing plan be filed when you register your clinical trial. This will give the
clinical trial registries adequate time to build the software and to test it in
their systems to show that it works. For data sharing to work seamlessly, it
requires a lot of planning, a lot of energy, and a lot of resources, and those
are not yet available, so to require that would mean that we would stop the
research machine because people simply don't have those resources available. We
think in the long run, we're going to get there because we need to make sure that
we honor the commitment to those people who enrolled in clinical trials. When
people put themselves in a clinical trial, they put themselves at risk. We owe
them a debt and this is a way to help pay that debt back. [Jen] Thank you, Dr. Drazen,
for having this conversation with me. I invite you to go to NEJM.org to read
the full statement. Thank you.