March 04, 2019 Monday
Bedtime Story
Understanding Clinical Trials in United States
Last night I had asked you to imagine
United States split vertically right down the middle through the states of
North and South Dakota, Nebraska, Kansas, Oklahoma and Texas.
In such a vertically divided United States
into roughly equal right and a left half you will see that most of the medical
research centers fall on the eastern part of the great nation.
There are only three major medical research
centers that the west coast can boast of, and all of them are located in the
state of California.
These three are the Stanford University
Medical center in the Santa Clara County very close to Palo Alto, the UCSF
Medical Center in San Francisco and Ronald Reagan UCLA Medical Center in
Westwood, Los Angeles.
But it is on the Eastern side of the United
States that serious funding is poured into far more number of research centers
in biological sciences and medicine with the West Coast mainly driving the
nation’s information technological revolution.
The Phase III clinical research is thus a
serious and expensive venture that requires joint collaboration of entire team
or multiple teams that comprise of patients, clinical investigators, hospital
staff, communications, meetings and everything else that you can imagine needed
in the logistics of such an operation.
By the end of the Phase III almost 75% of
the molecules tried end up in failures and the 25% that do pass the stage are
considered to be both therapeutically effective and safe.
This stage is in one sense the final
confirmatory phase where the molecule is recognized as a drug and is ready for
marketing.
The costs of the clinical research or
trials vary depending on the drug being tested, the type of disease, the number
of patients being recruited and the number of medical centers that are
involved.
In a study done on the cost of clinical
trials performed in the United States and published in 2016 in a paper titled
“Key cost drivers of pharmaceutical clinical trials in the United states” average
economics of such trials was explained and analyzed.
The result of the study was as follows:
“Therapeutic area was an important
determinant of clinical trial costs by phase.
The average cost of a Phase 1 study
conducted at a US site ranged from USD 1.4 million (pain and anesthesia) to USD
6.6 million (immunomodulation), including estimated site overhead and
monitoring costs of the sponsoring organization.
A Phase 2 study cost from USD 7.0 million
(cardiovascular) to USD 19.6 million (hematology) whereas a Phase 3 study cost
ranged from USD 11.5 million (dermatology) to USD 52.9 million (pain and
anesthesia) on average.
Across all study phases and excluding
estimated site overhead costs and costs for sponsors to monitor the study, the
top three cost drivers of clinical trial expenditures were clinical procedure
costs (15%-22% of total), administrative staff costs (11%-29% of total), and
sire monitoring costs (9%-14% of total).”
Stay tuned to the voice of an
average story storytelling chimpanzee or login at http://panarrans.blogspot.com
Good night Mon Ami and my fellow cousin ape.
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Another great educator and a teacher that I am aware of is
Professor Subhashish Chattopadhyay in Bangalore, India.
While I narrate stories, Professor Subhashish an electronic
engineer and a former professor at BARC, does and teaches real mathematics and
physics.
He started the participation of Indian students at the
International Physics Olympiad.
Do visit him here:
All his books can be downloaded for free through this link:
For edutainment and English education of your children, I
recommend this large collection of Halloween Songs for Kids:
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