Newsletter Mar 16

CLINICAL RESEARCH SOCIETY (CRS)

FDA Shares Thoughts on Young Animal Studies for Cancer Drugs
According to an article published
recently, officers from the US Food and
Drug Administration (FDA) say that
studies looking at the effects of drugs in
young animal populations in contrast to
their effects in adult animals are usually
not helpful in guiding pediatric clinical
development, particularly if such research
is the basis for the launch of a clinical
trial.
The authors of the article, John Leighton,
Haleh Saber, Gregory Reaman and
Richard Pazdur, of US FDA's Office of
Hematology and Oncology Products
(OHOP) in the Center for Drug Evaluation
and Research, arrived at their conclusion
after analyzing data from both publicly
accessible and non-public young animal

studies presented to the FDA to support

pediatric oncology research.
FDA and ICH Guidance
In 2006, FDA released its guidance,
Nonclinical Safety Evaluation of Pediatric
Drug Products, to assist sponsors design
non-clinical research in animals to
evaluate whether drugs' effects are
distinct in children in comparison to
adults, in scenarios where it would be
unethical or complicated to evaluate in
pediatric studies.
Later, in 2010, the International
Conference on Harmonization (ICH)
designed its guidance, ICH S9:
Nonclinical Evaluation for Anticancer
Pharmaceuticals,
which
makes

US FDA Proposes Ban on Powdered Gloves

US Food and Drug Administration (FDA)
has chosen to ban most powdered gloves
due to the fact that they cause a health
risk to health professionals and patients,
and new or modified labeling would not
be sufficient to decrease the risk.
In their recent announcement US FDA
states that:
"The suggested ban is applicable to
powdered surgeon's gloves, powdered
patient
assessment
gloves
and
absorbable powder for lubricating a
surgeon's glove."
Dr. Jeffrey Shuren, director for Devices
and Radiological Health at the FDA,
states that the objective of the ban is to
secure sufferers and health professionals
from risks they may not even be aware of.

accessible proof prior to suggesting the

ban. They examined all the accessible
scientific literature and feedback they
obtained following a Federal Register
Notice they posted in February 2011.
Powder in the form of cornstarch is often
included to gloves to make them simpler
for doctors, nurses and other health care
specialists to put on and take off. But,
notes the FDA, there are various factors
why powdered gloves pose health risks.
One cause is that in natural rubber latex
gloves, the aerosolized glove powder can
bring proteins that can result in
respiratory allergic reactions. This is not
the case, though, with synthetic (nonrubber) powdered gloves.
Read More

The FDA say they reviewed all the

www.clinicalresearchsociety.org

suggestions on what kinds of non-clinical

research need to be performed prior to
evaluating cancer drugs in humans. The
ICH guidance favors expediency in
launching pediatric participation in Phase
I studies, saying, "research in young or
immature animals are not generally
performed to be able to support the
inclusion of pediatric communities for
cancer treatment."
ICH's suggestions are based on the
rationale that data from adult sufferers
and enhanced safety monitoring can
offset the danger to pediatric patients
registering in these studies, given the lifethreatening nature of their condition.
Read More

March Highlights
A
new
study
reveals
that
Acetaminophen is an Ineffective
Treatment for Osteoarthritis
Consuming a Diet Rich in Vitamin C May
Decrease the Chance of Cataracts
Exercise May Decrease the Rate of
Cognitive Decline in Older Age
Social Media Binges and Depression
The connection Unearthed!!
Link between Stress Response and
Cardio Vascular Risk
Multi Gene Test Identifies Early Breast
Cancer Patients Who Can Be Spared
Chemo
FDA Publishes Draft Guidance on
Assessing Abuse Deterrence of Generic
Opioids
Is Moderate Drinking Really Good for
Health?
Stem Cell Therapy Allows Spinal regrowth in Animal Model
Why Smokers are at a High Risk of TB?

Novartis Agrees to Pay $25 Million to Settle China Bribery Investigation

Novartis decided to hand over $25 million
to settle a Securities and Exchange
Commission investigation into bribery
claims in China. It's the most recent
example of corruption allegations made
against the Switzerland-based Pharma's
operations in Asia.
As per the SEC, Novartis provided
Chinese
physicians
luxurious
entertainments which included a trip to
Chicago and Niagara Falls--and other
incentives to increase prescriptions of its
medicines in China.

The claims mirror those against a wide

range
of
other
Pharmaceutical
companies that have resolved similar
investigations by the U.S. government
and foreign agencies. The major
settlement and most far-reaching
example of bribery in China was the $489
million fine charged against GSK in 2014,
which capped off an investigation into
hundreds of millions in inducements for
physicians and other healthcare
representatives, many of them reserved
as travel and meeting expenses.

As per the SEC, the Chinese units of

Novartis and its generics business,
Sandoz, reserved illegal expenses as
legitimate expenditures. For example, two
sales representatives at Sandoz China
submitted $8,100 in expenses and it was
accepted by a regional sales manager,
which covered entertainment and
presents for healthcare professionals.
China
workers
also
maintained
spreadsheets that provided proof of a
quid pro quo setup:
Read More

Fruit Juices and Smoothies are Not as Good as We Think

The next time you provide your kids a
healthy smoothie rather than a soda, you
may need to keep in mind that it could
consist of up to 13 g/100 ml, equal to
about 2.5 tsps in a 3.5-oz serving, or
roughly two-thirds to a half of a child's
suggested daily sugar intake.
A new study, presented in the online
journal BMJ Open, states that the sugar
content of fruit beverages, natural juices
and smoothies, in specific, is
unacceptably high.
According to Yale Health, the average
American takes about 22 tsps of added
sugar daily; for teens, the figure is nearer
to 34. One 12-oz can of soda consists of
10 tsps of sugar.
The American Heart Association (AHA)

suggests only 3-4 tsps of sugar a day for

kids and 5 tsps for teens.
In the UK, guidelines suggest a maximum
of 19g, or just below 4 tsps for kids aged
4-6 years, and 24 g at age 7-10 years, or
just below 5 tsps, as per the UK's
National Health Service (NHS).
As awareness spreads about the effect of
sugary drinks on weight gain and cavities,
many individuals are switching to fruit
juices and smoothies as a healthy
alternative to sodas, iced tea and other
favorites.
Even 100 percent juice is not guilt free
Even 100% fruit juice is not as harmless
as it seems. The American Academy of
Pediatrics (AAP) suggest not providing

juice to babies under 6 months, and kids

aged 1-6 should have no greater than 4-6
oz, or one half to three quarters of a cup.
The suggested amount for 7-18 year-olds
is 8-12 oz, or 1-2 cups.
Investigators from the University of
Liverpool and the University of London in
the UK evaluated the sugar content per
100 ml (roughly 3.5 oz) of fruit juice
drinks, 100% natural juices, and
smoothies targeted at kids, using
information from the pack label.
They examined the quantity of "free"
sugars in 203 standard portion sizes (200
ml, or around 7 oz) of UK-branded and
store-brand products.
Read More

CRS Memberships & Certifications

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Ameerpet, Hyderabad-500038, India

Certifications:
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Coordinator
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GCP Training & Certification

CRS memberships with their membership

benefits provide the extra edge you need
to succeed. CRS is committed to
providing every person involved in
medical research, including students, the
means to reach their goals by offering a
set of valuable membership benefits.
Clinical Research Society offers multiple
training and certification programs which
are designed to meet the training needs
of the clinical research enterprise.
www.clinicalresearchsociety.org

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