Latest & Greatest
NIH Finalizes Single Institutional
Review Board Policy for Multiple-Site
Studies
Vice President Biden Unveils New
Open-Access Database to Improve
Cancer Research
As part of the Cancer Moonshot
Initiative, Vice President Joe
Biden recently announced
the Genomic Data Commons
(GDC), a next-generation,
open-access cancer database
that provides data access, data
analysis, and data sharing for
cancer research.
The database launched with
raw genomic and clinical data
from National Cancer Institute
(NCI) initiatives, such as the
Cancer Genome Atlas and the
TARGET (Therapeutically
Applicable Research to Generate
Effective Treatments) program.
The GDC contains patient
information, including which
treatments were used and how
patients responded, from more
than 14,000 patients. As more
data are added, the hope is that
the GDC will “form the basis
for a comprehensive knowledge
system for cancer … and would
become an important resource
for generating potentially
actionable and life-changing
information that ultimately
could be used by doctors and
their patients,” according to a
news release from NCI.
To support broader
data sharing, the GDC is
capable of accepting/or has
the functionality to accept
submissions of cancer genomic
and clinical data from
researchers around the world,
allowing those researchers to use
12
ASH Clinical News
the database’s analytic methods
to compare their findings with
other data in the GDC.
“Increasing the pool of
researchers who can access data
and decreasing the time it takes
for them to review and find new
patterns in that data is critical to
speeding up development of lifesaving treatments for patients,”
said Vice President Biden.
“With the GDC, NCI has
made a major commitment to
maintaining long-term storage
of cancer genomic data and
providing researchers with free
access to these data,” NCI Acting
Director Douglas Lowy, MD,
said in a press release from the
agency. “Ultimately, the GDC
will accelerate our efforts in
precision medicine.”
The database is accessible
through an NCI portal and is
interactive and searchable by
centralized and standardized
data on a unified and
interoperable platform. The
University of Chicago is housing
and managing the database for
NCI. Funding for the GDC falls
under the $70 million allocated
to NCI under the Precision
Medicine Initiative.
For more information, visit
gdc.nci.nih.gov.
Sources: The Washington Post, June 6, 2016; University
of Chicago News, June 6, 2016; National Institutes of
Health news release, June 6, 2016.
On June 20, 2016, the National Institutes of Health (NIH) finalized a
policy that permits a single Institutional Review Board (IRB) to review
human subject protections at all locations of a multi-center study.
The “Final NIH Policy on the Use of a Single Institutional
Review Board for Multi-Site Research” implements a draft version
of the policy issued in December 2014. The new rule is “intended
to enhance and streamline the process of IRB review and reduce
inefficiencies so that research can proceed as expeditiously as
possible without compromising ethical principles and protections
for human research participants,” according to the NIH news release
about the policy change.
“We were seeing delays and complications in moving research
forward in a way that wasn’t providing commensurate protections
for human research participants,” Carrie D. Wolinetz, associate
director for science policy at NIH, explained to Bloomberg BNA. “If
we thought that having multiple IRBs review the research resulted in
a stronger fabric of protection for participants, we would be all for it.
But there’s no evidence that that is the case.”
Under the new policy, NIH grant applications must include a plan
describing the use of a single IRB that will serve as the IRB of record
for all study sites. The policy wi ll take effect on May 25, 2017, and will
apply to all domestic sites of NIH-funded studies. The NIH plans to
issue guidance and resources before that date to help institutions adjust
to the changes.
Sources: National Institutes of Health news release, June 21, 2016; Federal Register, June 21, 2016.
Ibrutinib Granted
Breakthrough
Therapy
Designation for
Chronic GraftVersus-Host
Disease
The U.S. Food and Drug
Administration (FDA) has
granted breakthrough therapy
designation to the tyrosine
kinase inhibitor ibrutinib for
the treatment of patients with
chronic graft-versus-host
disease (cGVHD) after failure
of one or more lines of systemic
therapy. The FDA also granted
the therapy Orphan Drug
Designation for cGVHD.
The FDA’s decision was based
on data from a phase Ib/II study
of 28 patients with steroiddependent or refractory cGVHD
who received single-agent
ibrutinib. The study’s primary
endpoint was reduction in
cGVHD, according to National
Institutes of Health (NIH)
Consensus Response Criteria.
The overall response rate was 55
percent.
The most common allgrade adverse events (AEs) in
the trial were fatigue (50%),
bruising (25%), diarrhea (25%),
and nausea (21%). The most
frequently observed grade
≥3 AEs were fatigue, which
occurred in five patients, and
diarrhea, pneumonia, and
headache (2 patients each). Six
patients discontinued therapy
due to an AE, and three patients
discontinued after developing
progressive cGVHD.
Source: AbbVie press release, June 29, 2016.
August 2016