Page 95 - English For Nursing
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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?
                   ________________________________________________________________________________________
               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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