The Course of Action for the Case “Up, Up, and Away: Clinical Trials Go International”
The clinical trial involves a research investigation in which clinical or medical professionals volunteer to test a particular emerging treatment or interventions that are intended to detect, treat, or manage a specific medical condition. Its primary focus is on how people or patients respond to the new responses and any possible side effects that might occur in the course of the assessment. There are steps involved in the process of conducting the clinical trials and can deliver results by helping the professionals to gather the required information. The first step to undertake the clinical trial is by identifying the problem that relates to these professional goals. The medical practitioners involved determine whether the facts being investigated are social, environmental, or clinical before designating the procedure to be conducted.
Triggers are essential in opening any investigation since they help the researchers to get a starting point for their assignment. The clinical exploration ought to be triggered by those situations that are necessary to enhance research that the group of concerned people will undertake. The examination should consider all the ethical principles that present the values that are to be followed by clinical researchers. For instance, every clinical drug and medical device must undergo a process of clinical trials to be consumed by the final intended users, considering the economic and social value of the patients being attended through the test. The testing is necessary to determine the safety, effectiveness, and dosage of the drug before availing it to the patients (Eiken, 2019). The number of patients is increased as intended in every consecutive phase by investing enough resources that can manage the process. The concerned parties should identify the information gaps available by considering any lacking information that is relevant in administering the dosage and guaranteeing the right information that is gathered from the reliable sources. The clinical trial process should find the parties involved and the people who will be profoundly affected by the process. The outcomes of the trial should change a particular group of people who should be identified and given the right treatment since they can be affected by the findings of the dosage. The research team involves the doctors, the nurses, health care professionals, scientists, data managers, clinical trial coordinators, and the social workers (Nichols, 2018). The participants are required to sign an informed consent agreement before participating in the assessment.
Decision making on the prevalent values should be made by the medical officers to understand the ethical considerations and beliefs that are held by the staff, the medical facility, community, relatives, and any other participants of the process. The value analysis is necessary to understand how the concerned parties are to be treated as a way of upholding ethical standards to promote efficiency. When rolling out a trial in a particular community, it is necessary to determine if a cultural or language interpretation would be required to understand how the trial can be managed. The person to be selected should not be a staff family member or a patient to avoid conflict of interest in the examination. The steps undertaken should be appropriately analyzed, the course of action to be made should be understood, and any harm or benefit that can be obtained from the response should be seriously considered. This action helps the experiment’s management team to employ the necessary safety measures and guidelines for any predictable risks during the process. Subsequently, it ensures that all participants of the trial maintain the acceptable conduct without causing any unacceptable harm or alarm to society.
References
Eiken, M. (2019, August 28). Up, up, and away: Clinical trials go international. Markkula Center for Applied Ethics at Santa Clara University. Retrieved June 1, 2020, from https://www.scu.edu/ethics/focus-areas/bioethics/resources/up-up-and-away-clinical-trials-go-international/
Nichols, H. (2018). How do clinical trials work? Health News – Medical News Today. Retrieved June 1, 2020, from https://www.medicalnewstoday.com/articles/278779