Page 94 - English For Nursing

Listen to audio on major bleeding. Answer the following question.

1. What are the example of major bleeding?
_____________________________________________________________________________
2. What needs to be done by the patients if they suffer major bleeding?
_____________________________________________________________________________

3. Why does the patient of blood thinner cannot stop the medication?
_____________________________________________________________________________
4. What will you probably do first if you meet with a person who suffers major bleeding?
_____________________________________________________________________________

What is clinical trials?
Can you give any examples of clinical trials? Mention.

In Hunting for Cures, Ethics Can Strengthen Clinical trials
1 Clinical trials provide the cornerstone for that test the same drug constitute a portfolio of
evaluating the safety and efficacy of new drugs and studies, analogous to the way that a group of
therapies to treat disease. While trials are designed investments constitutes a portfolio of investments.
to follow established ethical and regulatory "Bottom line, the current system of research, ethics
requirements, Alex John London, the Clara L. and oversight is inadequate." - Alex John London
West Professor of Ethics and Philosophy at 5 Currently, individual trials are the focus of
Carnegie Mellon University, said he believes there regulatory oversight and ethical scrutiny. But
is room for improvement. London and Jonathan Kimmelman argue that
2 "Studies that lack social value aren't many of the same issues that determine the ethics of
morally benign," said London, who is the first individual studies also apply to whole portfolios of
author on a study examining the ethics of clinical studies. However, there is no mechanism in place
trial portfolios published in the August issue of The for evaluating those portfolio-level concerns.
Hastings Center Report. "They harm patients, suck 6 "This work came out of years of empirical
up resources that could be used elsewhere and [put research studying how drug developers and public
additional] cost burdens on healthcare systems that sponsors actually test drugs," said Kimmelman,
are already strapped." director of biomedical ethics unit at McGill
In search of treatment University and co-author on the study. "I was
3 People have the impression that drug surprised to discover that even if a drug for one
development follows an orderly progression where disease shows promise of working in a different
the results of previous studies inform future disease, trials are pursued simultaneously, making
research. According to London, this is an over it impossible to economize the patient risk and
simplification and is not always true. In reality, burden."
clinical trials are more complex. 7 Similarly, they argue that whether or not
4 The U.S. Food and Drug Administration an individual trial is ethical can depend on the
(FDA) requires multiple studies to establish that a composition of the larger portfolio of studies in
new treatment is safe and effective. These trials are which that trial is included. In part, this is because
initiated often at the same time to evaluate the the different studies needed to establish the safety
safety of a drug and to look for potentially beneficial and efficacy of a new drug play very different roles
effects in multiple diseases. The different studies in drug development. The information produced by

90