Stakeholders In Clinical Research Trials There Are Term Paper

Length: 2 pages Sources: 2 Subject: Medicine Type: Term Paper Paper: #51851205 Related Topics: Stakeholders, Department Of Veterans Affairs, Biomedical, Cancer Treatment
Excerpt from Term Paper :

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...

...

The government is also involved in the sponsorship of clinical trials. 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…

Sources Used in Documents:

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


Cite this Document:

"Stakeholders In Clinical Research Trials There Are" (2014, November 09) Retrieved November 26, 2022, from
https://www.paperdue.com/essay/stakeholders-in-clinical-research-trials-2153665

"Stakeholders In Clinical Research Trials There Are" 09 November 2014. Web.26 November. 2022. <
https://www.paperdue.com/essay/stakeholders-in-clinical-research-trials-2153665>

"Stakeholders In Clinical Research Trials There Are", 09 November 2014, Accessed.26 November. 2022,
https://www.paperdue.com/essay/stakeholders-in-clinical-research-trials-2153665

Related Documents
International Clinical Harmonisation Proper Systems in Place
Words: 1196 Length: 4 Pages Topic: Medicine Paper #: 10839935

International Clinical Harmonisation PROPER SYSTEMS IN PLACE The International Congress Harmonisation WHO Principles of Good Clinical Practice Clinical research is conducted to insure the safety and efficacy of health and medical products and practices (WHO 2002). In the past, randomized controlled trials gave most of the information about the safety and efficacy of these products and treatments. Randomized clinical trials were considered the foundation of evidence-based medicine but reliably only when conducted according to

Unethical Business Research Conduct Business Research Is
Words: 1012 Length: 3 Pages Topic: Sports - Drugs Paper #: 11875704

Unethical Business Research Conduct Business research is conducted for many reasons that are dependent on intended recipient of the research. For business marketers, research might include customer surveys of focus groups. When the research is for the development of a product, it can have a scientific basis and when it comes to stakeholders the research may include financial projections. This paper will therefore look at an article that focuses on some

Capstone Project Using Technology in Managing Data Within Clinical...
Words: 4518 Length: 12 Pages Topic: Black Studies - Philosophy Paper #: 93103390

Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general

Capstone Project Using Technology in Managing Data Within Clinical...
Words: 4518 Length: 7 Pages Topic: Black Studies - Philosophy Paper #: 77247729

Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general

Looking Into Using Technology in Managing Data in Clinical Trials
Words: 662 Length: 2 Pages Topic: Health - Nursing Paper #: 38646614

Technology in Managing Data in Clinical Trials Even a casual observer will undoubtedly make note of the range of high-tech solutions that are causing disruptive change in the process of clinical trials. From webinars and multi-day meetings to an expanding pool of literature, technology has been establishing itself as the key to an era fixated on measurable improvements like accelerating the research start-up phase, restructuring clinical trial information transmission, and

Analysing and Assessing Translational Research
Words: 6128 Length: 4 Pages Topic: Nursing Paper #: 12778519

Evidence-Based Practice Translation of Research in Evidence-Based Practice Nursing involves men and women who are willing to help the patients with their skills like health maintenance, recovery of ill or injured people and the treatment. They develop a care plan for the patient sometimes in collaboration with the physicists or therapists. This paper discusses the current nursing practice in which I am involved and needs to be changed. Identification of a Current Nursing