Less than one-third of clinical studies performed at major academic medical
institutions are published within two years of completion - a lapse that
deprives the scientific community of time-sensitive, valuable information,
reasons are unclear, but the consequences are profound," said study
co-author Dr. Harlan Krumholz, a professor of medicine at the Yale School of
Medicine in New Haven, Conn.
not reporting results, the scientific findings literature is harmed because it
is incomplete," Krumholz said. "Patients are harmed because their
doctors have access to only part of the evidence that has been generated, and
the people who agreed to be in the studies are dishonoured."
clinical trials are the best way to assess the effectiveness and safety of
medical drugs and devices, the study authors explained. However, "the
culture of medical research has evolved to the point where it is common
practice not to report or publish studies, leaving it to the discretion of the
researchers," Krumholz said.
evaluate human-study reporting practices at leading academic medical
institutions, the investigators examined information from the
ClinicalTrials.gov database in 2013. This database is the largest such registry
in the United States.
researchers focused on U.S. studies with registrations indicating that all
data-collecting efforts were scheduled to conclude at some point between 2007
and colleagues identified more than 4,300 completed studies, conducted by 51
well-known academic institutions.
found that none of the prominent academic centres were doing well. All had many
studies that were either not reported or published, or certainly not done
within even two years of completing the studies," Krumholz said.
when the government mandates the results be made public, they often go
unreported, he added.
only 29 percent of the studies were published within two years of completion,
the investigators found. And the findings of only 13 percent were reported on
the ClinicalTrials.gov website in the same time frame.
two-thirds of the studies were published, though often long after the two-year
wrap-up mark, according to the report in the Feb. 17 online edition of
patterns varied widely, Krumholz and colleagues found. While some major
academic medical centres published the findings of roughly 40 percent of their
fully completed studies within 24 months, others reported less than 11 percent
of their findings in that time frame.
regards to the ClinicalTrials.gov website, reporting patterns ranged from less
than 2 percent to about 40 percent. Similar variations were seen in reporting
results from completed stages of on-going clinical trials.
"there is little consequence to not publishing," Krumholz said,
calling this an increasingly common and "perplexing" practice.
have tried to understand what accounts for the lack of publication," he
said. "Certainly, undesirable results might be part of the issue. The
bottom line, though, is that it is an abrogation of our responsibility as
scientists and health care professionals," Krumholz added.
study published last March in the New
England Journal of Medicine found that only about one out of
10 clinical trials met federal requirements to report results on
ClinicalTrials.gov within one year of the study's completion.
2000, Congress authorized the creation of ClinicalTrials.gov to publicly report
information about clinical trials. Later, a new law expanded the website's
mandate, requiring sponsors of most trials to report basic summary results so
Americans could have access to the data, according to background notes in
the NEJM study.
been a lot of prior concern that industry often withheld evidence that came to
light later about their medical products, and that medical journals were
selectively reporting the positive results from trials," Dr. Monique
Anderson of Duke University, an author of the 2015 study, said at the time.
Francer, vice president of law for the Pharmaceutical Research and
Manufacturers of America, a Washington, D.C.-based trade group, said that
"biopharmaceutical companies remain committed to enhancing public health
through responsible clinical trial data sharing."
said his organization and its European counterpart - the European Federation of
Pharmaceutical Industries and Associations - abide by a set of principles
detailing their trial-data sharing goals.
these principles, he said, "member companies have committed to enhance
clinical trial-data sharing with qualified researchers, share results with the
patients who participate in clinical trials, enhance public access to clinical
study information, and reaffirm their commitment to publish medically
significant clinical trial results."
M. Krumholz, M.D., professor, medicine (cardiology), section of cardiovascular
medicine, department of internal medicine, Yale School of Medicine, New Haven,
Conn., and director, Center for Outcomes Research and Evaluation, Yale-New
Haven Hospital; Jeff Francer, vice president of law, Pharmaceutical Research
and Manufacturers of America, Washington, D.C.; Feb. 17, 2016, BMJ, online