Ethics Assignment
The Course of Action for the Case: “Up, Up, and Away: Clinical Trials Go International”
Problem Identified
In this case study, the major problem identified is a clinical issue since it involves a clinical trial on the drugs and medical devices that are to be sold to patients and other consumers. It is the process that is considered when a company is undertaking research and development for their products. Many biomedical firms usually apply the clinical trial in the development of pharmaceuticals and medical devices so that they can be used in treating the patients.
Triggers
The triggering issues in the clinical process are an increased number of patients who are enrolled in consecutive phases, which are necessary for giving the expected outcomes and maintain the ethical standards required by the practitioners. The emphasis of the process is that it should deliver the medication considering the safety, efficacy, and dosage of the drugs before availing it to patients and other consumers (Eiken, 2019). The cost involved in ensuring the proper functioning of each phase is more than twenty million dollars. Even though expensive, it is imperative as it will cover more patients in each phase of the trial process in the United States.
Information Gaps
The clinical trials within the United States are not only costly but also have proven ineffective due to the low rate of enrollment and high rate of patients dropping out; hence, many biomedical companies have turned to international trials. These big drug firms opt to conduct their clinical trials in developing and less developed countries, which provide a favorable environment for delivering the expected outcomes. Studies have been undertaken in those regions and around the world to obtain reliable information that can be effective in the development process. The studies help to reduce and eliminate the information gaps identified in the clinical trial process.
Parties Informed
Gathering information helps in providing data from different countries, populations, and patients who are involved in undertaking the clinical trial and delivering the anticipated results. Sufficient knowledge among the patients and the staff involved is necessary for accomplishing the core purpose of the trial. Since the process is conducted voluntarily and willingly, the population ought to be trained on the risks and benefits associated with the exercise (Eiken, 2019). Therefore, the process involves medical professionals, patients, relatives, social workers, scientists, clinical trial coordinators, data managers, and interpreters in case the trial is done in a foreign country.
Prevalent values
The information about the treatment testing process and the standard requirements should be provided by the company and medical facility as expected. The target population in developing countries such as Russia involves people who are not skillful or clueless about the clinical trials. Many of them are not aware of any side effects that are associated with administering the drugs, and they should, therefore, be well informed. The interaction between the doctors and patients during the trial process should be within the requirements of the process since all the necessary information should be passed by them, whether on drug responses or predictable results. After the process is completed and the expected outcomes obtained, it is ethical to ensure that there is no more interpersonal and interprofessional relationship between the participants of the trial (Nichols, 2018).
Interpreter
When the process is being conducted in a foreign country, the partakers of the trial who are conversant with the local culture and languages are necessary to provide the right interpretation of the process and results to the doctors. This initiative is essential for training the patients and trying to understand the different perspectives that the people have, and thus, an interpreter is required. It also helps identify whether the patients of the specific disease have a previous medical history, which can assist in ascertaining the effectiveness and safety of the dosage on the victim. The interpreter to be selected should have prior knowledge of the existing disease and should be well informed on how people perceive the ailment and their cultural orientation concerning visiting hospitals.
The course of actions and Consequences
After all the above elements have been adequately identified, the clinical trial team can start the process. Reliable information is gathered on the target population, and all the dynamics that are to be considered are identified during the exercise. The doctors should be aware that people can have side-effects depending on their medical history or other health complications. Safety for the patients and doctors involved in the process is crucial, and therefore, it is essential to ensure that neither party is negatively affected during the trial.
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