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Oversight of Clinical Trials
What are the obstacles involved with instituting institutional oversight in developing countries?
The biggest challenges with instituting institutional oversight in developing countries are: culture and the lack of regulations / enforcement. In the case of culture, many countries will have different ethical attitudes about various clinical trials. This is because most businesses do not have to meet as stringent guidelines and subjects are not provided with full disclosure. These issues are problematic, as many nations may have existing regulations in place. Yet, there is a lack of will to address these causes, based upon the traditions embraced by the medical community. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
The lack of regulations and enforcement; is from many developing nations not conducting clinical trials. In these kinds of situations, medical research is something that is relatively new. This means that there is a lack of resources, regulations and enforcement of the most accepted practices. These issues are challenging, as they will prevent the trial from providing various disclosures to patients and ensure that researchers are following the highest ethical practices. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
These areas will make it harder for manufacturers to market and sell...
This is because there are questions surrounding the research, tests and safety. Out of caution, many will require firms to meet standards which are in compliance with their guidelines. This costs firms more to develop and market the drug to consumers. Moreover, some firms could have unknown side effects, which impact customers in emerging markets. This is from not fully testing it or having procedures in place to make certain that everyone is following the widely accepted standards. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
How do you think the obstacles can be overcome?
To overcome obstacles, it is advisable for firms to partner with different universities. They have research departments, who have worked with other organizations and understand the different procedures that must be followed. This reduces the chances of finding entities and individuals who abide by different practices. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
In many developing countries, these issues have created contention about marketing and promoting drugs overseas. When this happens, it is considerably more difficult to invite a change in attitudes. This increases the chances that any kind of clinical trials may be deemed as inconclusive. ("ICH Guidance," 1997) ("The Nuremberg Code," 2000)
Those who are…
References
ICH Guidance. (1997). HCSCGC. Retrieved from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6- eng.php#2.0
The Nuremberg Code. (2000). NIH. Retrieved from: http://history.nih.gov/research/downloads/nuremberg.pdf
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