Difference between revisions of "Resource:E273cee3-0907-4841-9126-9cee08518338"

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|Resource Type=Cases
 
|Resource Type=Cases
 
|Title=Up, Up, and Away: Clinical Trials Go International
 
|Title=Up, Up, and Away: Clinical Trials Go International
|Is About=This is a short textual fictional case about running clinical trials in the United States. In this case a company called Rx answers questions about how and where clinical trials are performed.
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|Is About=This is a short interview with a research who describes some of the ethical issues that arise from running international clinical trials. The researcher gives the example of the fictional US based company Rx who wants to run a trial in Russia for a certain medication. One reason for such a company to 'outsource' a clinical trial is lower costs in other countries. Questions asked in the case include 'what is the quality of the informed consent?' and 'can you promise participants to receive a certain drug for the study period, but not afterwards?'
|Important Because="Every drug and medical device must undergo a series of clinical trials in order to be sold to consumers. Clinical trials are an essential step in the research and development process for drug companies. Clinical trials consist of three stages, with an increasing number of patients enrolled in each consecutive phase. The trials are important to determine safety, efficacy, and dosage for the drug prior to making it available to patients. Clinical trials are one of the most expensive steps in pharmaceutical and device development for biomedical companies. Each phase of the trial can cost up to twenty million dollars to run<ref>https://www.scu.edu/ethics/focus-areas/bioethics/resources/up-up-and-away-clinical-trials-go-international/</ref>."
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|Important Because=As described in the case:  "Clinical trials are one of the most expensive steps in pharmaceutical and device development for biomedical companies. Each phase of the trial can cost up to twenty million dollars to run."<ref>https://www.scu.edu/ethics/focus-areas/bioethics/resources/up-up-and-away-clinical-trials-go-international/</ref> However, clinical trials are an important step to ensure the efficiency, safety and dosage of a drug.  
 
<references />
 
<references />
 
|Important For=Researchers; PhD students; Research integrity trainers
 
|Important For=Researchers; PhD students; Research integrity trainers

Latest revision as of 13:03, 14 October 2020

Cases

Up, Up, and Away: Clinical Trials Go International

What is this about?

This is a short interview with a research who describes some of the ethical issues that arise from running international clinical trials. The researcher gives the example of the fictional US based company Rx who wants to run a trial in Russia for a certain medication. One reason for such a company to 'outsource' a clinical trial is lower costs in other countries. Questions asked in the case include 'what is the quality of the informed consent?' and 'can you promise participants to receive a certain drug for the study period, but not afterwards?'

Why is this important?

As described in the case: "Clinical trials are one of the most expensive steps in pharmaceutical and device development for biomedical companies. Each phase of the trial can cost up to twenty million dollars to run."[1] However, clinical trials are an important step to ensure the efficiency, safety and dosage of a drug.

For whom is this important?

Other information

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