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...
QuintilesIMS services the healthcare industry and plans on expanding their reach internationality. Turkey is a country that has experienced changes in recent years. They offer universal healthcare with private health insurance options for individuals. The county is also looking for foreign investors within their healthcare sector, presenting a great opportunity for growth for the company. Quest Diagnostics is also looking to expand and they offer laboratory services and information for clinical
Benchmark-Research Critique and PICOT statement This article is a research critique on the paper titled 'Home Telehealth for Patients with Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis' by J. Franek. The research paper under review was published by the Ontario Health Technology Assessment Series. Although there isn't a direct statement that refers to Problem statement, there is a title that highlights the "Objective of the Analysis." There is an excerpt of
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 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
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
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
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