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Stakeholders in Clinical Research Trials
There are various stakeholders involved in clinical trials. These include, but they are not limited to, funding agencies, the patient, the government, regulatory and oversight boards, the general public, insurers (if any), and the industry. In essence, these stakeholders not only influence, but also contribute to the process as well as outcome of clinical trials in a variety of ways. Below, I concern myself with three key stakeholders: the government, industry, and the subject.
Government: the government is actively involved in the regulation of clinical trials. It is important to note that typically, the government plays the regulatory role through various federal agencies such as the Food and Drug Administration - FDA. FDA, for instance, plays an active role in trials that involve "new drugs or significant new uses for already-approved drugs, through the Investigation New Drug (IND) Application process" (Institute of Medicine, 1999, p. 4). For this reason, registration for clinical trials, adverse events reporting, as well as insurance are closely monitored by the government through its various organs. The government, therefore, ensures that clinical trials are conducted safely and that patients are not exposed to unethical or criminal practices in the course of the said trials. The...
Some of the government agencies that actively sponsor clinical trials include, but they are not limited to, the Department of Defense and the Department of Veteran Affairs (Institute of Medicine, 1999).
Subject: volunteer subjects in clinical trials, as the National Institutes of Health - NIH (2014) points out, play a critical role in the development of knowledge that has the potential to "improve the health of future generations." As NIH further points out, without their active participation, the various goals and objectives of clinical trials cannot be accomplished. It should also be noted that by being inquisitive of the nature and side-effects of trials, as well as expertise of those running the tests, subjects contribute to the betterment of the process, and hence better outcomes. In my opinion, subjects are amongst the most important stakeholders in the clinical trial process as without them, such trials would largely be ineffective.
Industry: the most important industry members in this case are non-governmental sponsors (i.e. pharmaceutical players), coordinators and investigators, and institutional review boards. In essence, the industry plays a very important role in the proper monitoring of investigations throughout the process, surveillance…
References
Gelband, H. (1999). A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Mechanisms. Washington, DC: National Academies Press.
Kutz, G.D. (2009). Human Subjects Research: Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical Manipulation: Congressional Testimony. Darby, PA: Diane Publishing Co.
National Institutes of Health -- NIH. (2014). FAQs About Clinical Studies. Retrieved from http://clinicalcenter.nih.gov/participate/faqaboutcs.shtml
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