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 fictional case about running clinical trials in the United States. In this case a company called Rx answers quetions about how and where clinical trials are done.
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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 of 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.  
 
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|Important For=Researchers; PhD students; Research integrity trainers
Website
 
|Important For=Researchers
 
 
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{{Link
 
{{Link
 
|Has Link=https://www.scu.edu/ethics/focus-areas/bioethics/resources/up-up-and-away-clinical-trials-go-international/
 
|Has Link=https://www.scu.edu/ethics/focus-areas/bioethics/resources/up-up-and-away-clinical-trials-go-international/
 
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{{Related To
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|Related To Resource=Resource:08657792-f22e-486e-a034-c78fb9a2f39f;Resource:4c1137a3-8b5e-411e-bc98-18ae6818d7b8
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|Related To Theme=Theme:9ac8c1db-f98b-41ee-858d-a8c93a647108
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{{Tags
 
{{Tags
 
|Has Virtue And Value=Accountability
 
|Has Virtue And Value=Accountability

Latest revision as of 14:03, 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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