BACK of the BOOK
Heard in the Blogosphere
Journal Editors to
Researchers: Show
Everyone Your Clinical Data
With a new proposal, the International
Committee of Medical Journal Editors have
sent a message to researchers looking to
publish in the journal: share your clinical
data. This proposal indicates that authors
would have to share their clinical trials
data as a consideration for publication of
a clinical trial report. Editors and researchers weighed in on the proposal.
“Sharing data will increase confidence
and trust in the conclusions drawn from
clinical trials. It will enable the independent confirmation of results, an essential
tenet of the scientific process. It will foster the development and testing of new
hypotheses. It will also help to fulfill our moral obligation to study participants, and
we believe it will benefit patients, investigators, sponsors, and society.”
—The editors of the Annals of Internal Medicine family of journals
“As it stands now, medical scientists can publish their findings without ever making
available the data upon which their conclusions were based. Inaccessible data is a problem
rife throughout medical science. Industry traditionally held its data close – but so did
academics. But this practice shields data from scrutiny. It forgoes an opportunity to
crowdsource knowledge from scientists who weren’t associated with the original study. It
also violates the sensible practice of showing your work, not just the presumed answer.”
—Harlan Krumholz, MD, discussing the International Committee of Medical Journal
Editors’ proposal to make researchers publicly share their data as a condition
of publishing, on NRR’s “Morning Edition”
“Many of us who have actually conducted clinical research, managed clinical studies
and data collection and analysis, and curated data sets have concerns about the
details. … A new class of research person will emerge – people who had nothing to do
with the design and execution of the study but use another group’s data for their own
ends, possibly stealing from the research productivity planned by the data gatherers.
There is concern among some front-line researchers that the system will be taken
over by what some researchers have characterized as ‘research parasites.’”
—Dan L. Longo, MD, and Jeffrey M. Drazen, MD, editors of
The New England Journal of Medicine
Look for more on this heated topic in future issues of ASH Clinical News.
Personalized Medicine: A Faustian Bargain?
“Before geneticists can personalize diagnostic tests and cures, they have to decode the complex machineries behind
our genes and their variants. To do so, they need a lot of data – not only genetic, biological, and clinical but also
lifestyle information – about a lot of individuals from diverse backgrounds. The success of personalized medicine will
depend on our capacity to empower patients by lowering the economic and financial barriers to benefiting from the
best course for prevention or care. … The way forward is to make sure that tomorrow’s biomedical enterprise helps
those who are not part of the global wealthy minority.”
—Eleonore Pauwels and Jim Dratwa, discussing the prohibitive cost of genetic testing in Scientific American
Adding the Patient Voice to Drug Development
“In any other industry, there i s user-centered design and consumer science. And how this area evolved without the
patient voice is baffling to me, too. … Patient-focused drug development may be seen as a great disruption, but
it’s common sense. Identifying unmet needs and understanding therapeutic burden, risk-benefit, endpoints, and
outcomes of importance to patients should always begin through work with the patient community. It makes much
more sense than trying to backfill it into research or rescue trials that are in trouble.”
—Bray Patrick-Lake, director of stakeholder engagement for the U.S. Food and Drug Administration and Duke University’s Clinical Trials
Transformation Initiative, in Politico
44
ASH Clinical News
The Best Missions for a Cancer
Moonshot
In his final State of the Union address, President Obama
put Vice President Joe Biden in charge of a “moonshot”
program to conquer cancer, but some cancer researchers
are concerned that the idea of curing cancer with a massive
government program relies on an outmoded, simplistic
model of the disease. Four cancer specialists weighed in on
the moonshot program in The New York Times.
“Additional resources are sorely needed in the fight
against cancer — but no moonshot will be successful
unless the current program is given the flexibility
to act more efficiently and quickly. … The president
should appoint a cancer czar who can also coordinate
government resources with the private sector and have
budgetary authority over the entire cancer program,
which is now housed in several government agencies.”
—Vincent DeVita, MD, the Amy and Joseph Perella
professor of medicine at Yale School of Medicine
“The more we learn about cancer, the more we learn
about cancer prevention. A successful moonshot will
develop better ways to prevent cancer and better ways
to disseminate prevention information. Prevention is
ultimately, less costly than treatment in terms of both
suffering and money.”
—Otis Brawley, MD, chief medical officer of the
American Cancer Society
“Sustained, robust federal funding for clinical research
is central to continuing our progress against cancer, but
Congress and the administration should do whatever is
needed to ensure that clinical outcomes for millions of
individuals with cancer aren’t locked away in medical
records and databases that do not communicate. We
need to rapidly learn from every cancer patient today to
improve the care for patients tomorrow.”
—Julie Vose, MD, MBA, the Neumann M. and Mildred
E. Harris professorial chair and chief of the oncology/
hematology division at the University of Nebraska
Medical Center
“An unprecedented national effort is needed to train
and support physicians implementing new diagnostic
and therapeutic strategies. Expensive, to be sure, but
the cost of not doing it is the loss of lives and all that
our friends, colleagues and loved ones would have
contributed to the world is surely beyond tally.”
—Andy Futreal, PhD, interim chairman of the
Department of Genomic Medicine at the University of
Texas MD Anderson Cancer Center
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March 2016