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Clinical Trials for Medical Treatments, Essay Example

Pages: 1

Words: 317

Essay

No specific drug was identified for this trial. However, it was mentioned that they pertained to testing for evaluating whether a product is safe and its effect when consumed by the public. Further it was explained that doctors and other health professionals were selected to conduct the tests. Precisely, there are protocols through which they are executed. These happen to be definite guidelines established Food and Drug Administration (FDA).This is done to ensure that participants drafted into these trails are quite aware of the its procedures and consequences being in total agreement of the outcomes. It is important that researchers treat participants with the highest degree of safety and the truth concerning the trial is fully disclosed (Clinical Trial, 2013)

Research related to trails conducted by FDA reveal that compliance with principles of good clinical practices (GCPs) is the goal when tests are conducted by this organization. Principles of Good Clinical Practice (GPC) include adequate human subject protection (HSP), which is a universal critical requirement when research involving human subjects is undertaken. As such, a number of countries have elected to apply GCP guidelines as it pertains to laws, principles and regulations when executing trials involving human subjects. Importantly, FDA since its participation in clinical trials in 1970 has been compliant with both GCP and HSP regulations (Science and Research, 2013).

Ultimately, a bioresearch monitoring (BIMO) program embraced by FDA allows for on-site inspections of both clinical and nonclinical studies. This program supports ‘research and marketing applications/submissions to the agency’ (Science and Research, 2013).  Agencies wishing to conduct trails must obtain permission from the Center’s BIMO program. Thereafter, they must comply with laws set forth in GCP and HSP regulations (Science and Research, 2013).

Works cited

Clinical Trials. US Food and Drug Administration Clinical Trials for Medical Treatments. 2013. Clinical Trials. Accessed 17th September, 2013 from http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTria

Science and Research. Clinical Trials.US Food and Drug Adminstration.2013. Accessed 17th September, 2013 from http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

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