Stakeholders in Clinical Research Trials There Are

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 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 throughout the process, surveillance of the process to guarantee that protocols are not breached and that safety measures are enhanced, review and evaluation of evidence obtained, etc. Institutional review Boards -- IRBs are established with an aim of reviewing and monitoring "biomedical and behavioral research in clinical trials involving human subjects, with the intended purpose of protecting the rights and welfare of the research subjects" (Kutz, 2009, p. 1).

In that regard, therefore, IRBs come in handy in addressing some of the problems or issues that have got to do with human subjects. It is also important to note that the industry as a whole has a huge role to play when it comes to ensuring that the integrity of the process is maintained by, amongst other things, facilitating full disclosure of the information deemed relevant. Conclusion Cooperation between the various stakeholders.