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Minimizing Risk in a Study
One of the biggest challenges in conducting pharmaceutical research are the risks involved. This is because they can increase the potential legal liabilities and have a negative impact on everyone. To address them requires looking at: the circumstance for exclusion / inclusion / the maximum results, who approves the modifications and what can cause a study to end prior to its completion. Together, these different elements will illustrate how the process occurs and the different variables that are utilized throughout the process. (Konterman, 2010)
Under what circumstances would you modify inclusion and exclusion data to minimize risk and to maximize benefits of the research outcome? Who must approve modifications?
The circumstances that will shift modification of risk in Phase III trials are the side effects and the impacts they will have on participants. This is challenging, as these issues could have short or long-term consequences. In these kinds of situations, they are excluded from the study for safety reasons. Those who are suffering from specific conditions will be allowed to voluntarily participate. This is because, measuring the effects of the treatment will have an impact on them and the way they address critical...
The result is that they can receive better care and possibly address the underlying causes associated with their condition. This allows for the maximum benefits by measuring the what is happening and determining if the drug is safe for the general public to consume. To approve the modifications, the company must submit the changes to the Office For Human Research Protections (OHRP) and the Department of Health and Human Services (HHS). They are making sure that the changes are safe and having the greatest impacts on stakeholders. ("Inside Clinical Trials," 2015)
Situations exist in which it is still appropriate to conduct Phase I trials, even though the risks outweigh the benefits. In what situations would this be the case and why?
Phase I trials are conducted when a possible side effect is discovered. This is a direct threat to the safety of patients and requires researchers taking another look at the issues impacting the development of the drug. For example, in the early 2000's, Imcolne was facing considerable challenges with the trials in their cancer drug. To address them, they went back to Phase I and started reevaluating the different steps. This was a risky move as investors became nervous and some lost confidence in the…
References
Inside Clinical Trials. (2015). FDA. Retrieved from: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143531.htm
Konterman, K. (2010). Anti-Body Engineering. New York, NY: Springer.
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