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In Feb. 2014, Johnson & Johnson announced that it was making all of its clinical trial data available
to scientists around the world. It has hired my group, Yale University Open Data Access Project, or YODA,
to fully oversee the release of the data. Everything in the company’s clinical research vaults, including
unpublished raw data, will be available for independent review.
Today, more than half of the clinical trials in the United States are not published within two years of
their completion or never published at all. The unreported results, not surprisingly, are often those in which
a drug failed to perform better than a placebo. As a result, evidence-based medicine is, at best, based on
only some of the evidence, implying that full information on a drug’s effects may never be discovered or
released.
Even when studies are published, the actual data are usually not made available. End users of
research—patients, doctors and policy makers—are implicitly told by the researchers to “take our word
for it.” They are often forced to accept the report without the prospect of other independent scientists’
reproducing the findings—a violation of a central tenet of the scientific method.
To be fair, the decision to share data is not easy. Companies worry that their competitors will benefit,
that lawyers will take advantage, and that incompetent scientists will misconstrue the data and come to
mistaken conclusions. So Johnson & Johnson and companies like Medtronic that have made moves toward
transparency deserve much credit. The more we share data, however, the more we find that many of these
problems fail to materialize.
In 2011, YODA struck a deal with Medtronic to release all the data on one of its products—a device
that stimulates the production of bone. At the time, questions had been raised about the device’s safety
and about the conflicts of interests of some of the company’s researchers. Medtronic made the unusual
decision to respond to the debate by releasing the device’s data for independent review. We commissioned
and published two independent reviews of the data, and now have made them globally available.
Interestingly, the reviews produced somewhat conflicting results. One found that the device was no
better than a bone graft and might be associated with a slight increase in cancer, while the other found that
the device was effective and the cancer risk inconclusive. To us, these differences reinforce the value of
open science: now the data are out there for further study.
This doesn’t mean that anyone can gain access to the data without disclosing how they intend to use
it. We require those who want the data to submit a proposal and identify their research team, funding and
any conflicts of interest, and exclude those who seek data for commercial or legal purposes. The applicants
have to complete a short course on responsible conduct and sign an agreement that restricts them to their
proposed research questions. Most important, they must agree to share whatever they find. Our intent is
not to be tough gatekeepers, but to ensure that the data are used in a transparent way and contribute to
overall scientific knowledge.
According to the passage, what happened after more companies made their data available to the public?
AThese companies gained benefits.
BLawyers won more lawsuits for them.
CPeople learned more about their products.正確答案
DThey received more orders from hospitals.
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