Posted: January 5th, 2023
Clinical Research Trials
Clinical research is a medical study that uses human beings as the primary participants. There are two kinds, observational research, and clinical trials. Observational researches examine people in their natural settings. Surveyors collect data, categorize participants according to extensive features, and compare results over time. Clinical researchers, for instance, may acquire data through interviews and questionnaires to acquire valuable insights regarding how particular behaviors impact on cognitive functions. Observational clinical research provides an opportunity to recognize new opportunities for clinical trials. Friedman, Furberg, and DeMets (36) describe clinical trials as researches conducted on people that are targeted at assessing a surgical, behavioral, or medical intervention. Clinical trials also play vital roles in the way they help to understand whether a new drug or device is serving the targeted functions. Typically, a clinical trial is utilized to learn if a new treatment is more appropriate and does not have any side effects compared to standard form (Friedman, Furberg and DeMets 40). Still, other clinical trials test ways to avert a health issue. A clinical trial may also consider how to improve the lives of those living with life-threatening conditions or serious health concerns. The other function of a clinical trial is to find out how caregivers perform their duties and whether they impact positively on patients (Friedman, Furberg, and DeMets 41). Nevertheless, the U.S. Food and Drug Administration must approve a clinical trial.
Institutional Review Board (IRB) is an important aspect of clinical trials because the group provides directives on how the clinical research ought to happen. Under FDA directives, an IRB is a body that has been legally and formally formulated to monitor and review biomedical studies involving human participants. Following FDA directives, an IRB can verify, modify, or disapprove a clinical trial (FDA). The body’s reviews play an essential function in the protection of the welfare and rights of human participants in research. IRB relies on various sources to gain valuable information about its processes and what it ought to do. The IRB offers directives for appropriate clinical practice and clinical trials and offers valuable information for health practitioners (FDA). Nevertheless, failure to follow IRB guidelines could pave way for the violation of welfare and rights of people taking part in the study.
A clinical trial is likely to achieve the targeted goals when the process has a reliable sponsor. Friedman, Furberg, and DeMets (72) describe a sponsor as an organization, group, institution, firm, or individual who is in charge or settles the expenditures and gathers and analyzes information. The sponsor is in charge of initiating, managing, and financing or facilitating the financing of clinical trials and bears the legal and financial costs associated with the research process. In addition, the sponsor is also in charge of ensuring that the process achieves integrity and quality outcomes, and ensures that suitable approvals are acquired before the start of the clinical trial, that directives of any approvals are followed during the process of study, and ensures that the practice adheres to appropriate ethical directives (Friedman, Furberg and DeMets 75). Sponsors may also ensure that the team handing the initiative display respect, integrity, beneficence, and justice. The vital functions sponsors play in clinical trials may render the process less fruitful when they lack.
A team in charge of clinical research trials must pay attention to all the components of informed consent to achieve the best results. Friedman, Furberg, and DeMets (85) define informed consent as the practice of informing potential participants about the primary features of a clinical trial, and what their participation will entail. Friedman, Furberg, and DeMets (85) argue that informed consent is one of the essential aspects of the key aspects of ethical conduct of clinical trials with human participants. Informed consent is an essential component during enrollment in a clinical trial because it allows potential human participants all the information they require to know why they are taking part in the research.
A clinical research trial is likely to produce the anticipated outcomes when the team in charge of the process considers the good clinical process. Researchers and others in charge of the process should abide by the three primary principles of good clinical practice. The team overseeing the practice must show respect for everyone, show justice, and practice beneficence. Following the principles of a good clinical process presents a better chance to achieve the anticipated outcomes.
More fundamentally, the principal investigator plays a vital function in making a clinical trial successful. Friedman, Furberg and DeMets (97) define a principal investigator (PI) as the medical practitioner, usually a physician who oversees the implementation of a clinical trial. The guidance of the PI provides a suitable chance to build a robust foundation for a prosperous clinical trial. The PI also plays a vital function of delegating responsibilities to individual members of the investigating team (Friedman, Furberg, and DeMets 97). The PI must conduct research that adds to generalizable information while safeguarding the welfare and rights of human participants. Therefore, all clinical trials should rely on the guidance of qualified and competent PIs who are likely to steer the exercise in the right direction.
FDA. “Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials.” FDA, 2019, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials . Accessed 28 April 28, 2021.
Friedman, Lawrence, Furberg Curt and DeMets David. Fundamentals of Clinical Trials. Springer, 2010.
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