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studies that occur early on in the development of a 9 Similar to oversight bodies to promote
new drug is most useful when it feeds into ethics in clinical trials, London and Kimmelman
subsequent trials that provide a more definitive test also propose developing a portfolio-level data safety
of the hypothesis that a new drug works. monitoring board. The board could facilitate
Reducing Harms, Improving Outcomes planning, coordination and use of information
8 London said he believes that a number of within a portfolio. This approach could maximize
organizations have a role to play, including the the use of medical data, promote a fair and
Institutional Review Boards (IRBs), drug regulators equitable distribution of cost and minimize the risk
and data monitoring committees, which are to patients.
charged with implementing the moral frameworks 10 "Bottom line, the current system of research,
used to evaluate the safety and efficacy of clinical ethics and oversight is inadequate. The mechanisms
trials. He said they could leverage their combined in place for evaluating clinical trials are incapable of
influence to broaden the base of information used addressing a range of important issues unless they
to judge the strength of individual studies. These are changed to consider portfolios of trials,"
groups could consider whether individual trials are London said. "We hope now there will be increased
part of a portfolio of studies that is likely to generate scrutiny and attention given to what the best
socially useful information and either prohibit those mechanism is to fill this gap."
trials that are not or ensure that portfolios are
adjusted appropriately. (Taken from:
https://www.cmu.edu/news/stories/archives/2019/november/ethics-
strengthen-clinical-trials.html)
Do all the following statements agree with the views of the writer in the reading passage?
Write: TRUE if the statement agrees with the writer
FALSE if the statement contradicts the writer
NOT GIVEN if it is impossible to say that the writer thinks about this.
1. The improvement on conducting clinical trial possibly happens although there
are several regulations and ethics must be obeyed during the trials. (T/F/NG)
2. The development of a drug always followed the research done previously. (T/F/NG)
3. Several experiments, researches and trials might be done at the same time to one
kind of drug. (T/F/NG)
4. The research that is done for one medicine for certain disease may have
surprising result as in cure another disease. (T/F/NG)
5. The trials in previous studies will only beneficial if they provide a definite result
on how the drug work. (T/F/NG)
Read the passage. Answer the following questions.
1. Why do researchers do clinical trial?
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2. What do the writers hope for the future of clinical trials ethic?
________________________________________________________________________________________
3. What does the role of several government organization in the clinical trials?
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