Stakeholders in Clinical Research Trials
The field of medicine is an area of constant change and evolution. This constant evolution is deeply linked to research. Moreover, the field of medicine and all its advances would not be possible without being nourished by clinical research, which gives life to the experimentation and application of the results in the form of treatments for the prevention and cure of diseases. However, to achieve completion of a clinical investigation the agreement of all stakeholders is necessary. Each stakeholder has an important part in the process and the outcome of all clinical research. This paper intends to summarize the most relevant clinical research stakeholders and their role: government, industry, and subject (NIH
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The government is undoubtedly one of the principally influential entities in the field of scientific research. It has among its responsibilities the regulation of any clinical trial to be carried out through the entity of the Food and Drugs Administration (FDA) Ginsberg, D., & Whitaker, R., 1999). The government is the entity that carries out everything related to the legislation and policy, every law of protection to subjects who are volunteers in clinical research, (an example to the offices inside government that works with human safety is the Office of Human Research Protection), this involving all parts, industry, researchers, methodology, protocols. In the last years it has also been responsible for the initiative of providing funds so that patients diagnosed with a disease or disease, who may be willing to volunteer, can be treated through the use of experimental treatments, and can count on public health coverage in the process of the same. In charge of the regulation of clinical studies. It is also one of the entities that promotes on its diverses online sites, clinical trials available to interested
Regulate the clinical data by enforcing stringent data management practices and mitigate the deviation in data collection and recording. The study protocol will define the source of data collection with Case Report Forms (CRFs), method of storage paper/ electronic and information retained for data archiving. Each subject will be identified with unique ID and Subject Identification Log will be maintained separately from trail analysis documents. The DMS prevents unblinding of specific documents, which protect the privacy and confidentiality of the subject, unless required by the study protocol. Identifiable documents and records will be maintained in accordance with the data retention period as specified in the protocol and the requirement of the regulations and IRB. Any update or changes implemented will be recorded in the revision history of the respective documents. The clinical trial team will be trained on clinical documentation and
The IRB is an administrative body which has been established to make sure research participants' rights are protected. IRBs review all aspects of the researchers' project: the study design, the recruitment process, the participant population, the informed consent document and process, the risk/benefit ratio, privacy and confidentiality, data storage and protection, and safeguards for vulnerable participants (University of St. Francis, n.d.). In this way, participants' rights are protected because the effort is made even before the research begins. The review process ensures that participants are chosen fairly and informed adequately and the information collected during research is safeguarded through collection, use, and storage. Research using human participants is such an important part of medicine that it is imperative it is performed in a way that its intrigue is not compromised.
In the United States, the basis for ethical protection for human research subjects in clinical research trials are outlined by the Belmont Report developed in the late 1970’s. This document, published by the Nation Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, highlights three important basic principles that are to be considered when any clinical trial will involve human research subjects. They are; respect for persons, beneficence, and justice. (Chadwick & Gunn, 2004)
Perspective Stakeholders in health and social care can be referred to a person, group or organization that has interest or concern in an organization. Stakeholders can affect or be affected by the organizations actions, objectives, and policies. Some examples of key stakeholders in health and social care are inspecting bodies, managers, employers, government and its agencies, owners of care services, owners of local businesses, suppliers, trade unions, service users, and the community which the organization serves. For example, a local health and well-being strategy may be developed by;
The patient, LL, is a twenty four year old female who was diagnosed with obsessive-compulsive disorder five years ago. Around the ago of eighteen, LL started to experience many symptoms of obsessive-compulsive disorder. She had just started her freshman year at a local college and moved into the dorms with a random roommate. LL was constantly washing her hands and grossed out by the germs, so she came to realize she had a phobia of germs. She would begin sweating and having major anxiety when people went to shake her hand or her roommate would touch her food or any of her things. LL started skipping class and isolating herself in her room in order to avoid contact with other people. When her grades dramatically declined,
Recognition of the gap that exist between research finding and their application to practice is growing, DNP must be able to translate newly discovered relevant scientific knowledge into their provision of health care and navigate in the health care system to improve patient outcome. both educational pathway are completing one another, from research to practise , collaboration is an essential skill for all researcher and practitioner in the 21th century health care.
trials of investigation medical products. The FDA also has to review and approve in a
O'Brien (2013) defines RCT as a research technique that has been through the ages. It first was applied in medical studies. Today, it is a quantitative method widely used in clinical trials where participants answer or confirm a research question. Clinical trials that are designed with RCT in a medical context focus on prioritizing the protecting of human participants with the aid of ethical criteria; however, at the discretion of the researcher (O'Brien, 2013).
When caring for patients it is fundamentally important to have a good selection of up to date evidence Based Practice clinical articles to support research strategies, this allows professionals to assemble the most resent and accurate information known which enables them to make decisions tailored to the individual’s plan of care. It is essential to have clinical expertise and have the involvement from the individual patient, they must have full engagement and incorporation in order to have the accurate evaluation.
A major hurdle in this academic career that I hope to have is going to be the lack of expertise in the designing, implementation and evaluation of clinical trials.
Tunis S., Stryer D., Clancy C. Increasing the Value of Clinical Research for Decision Making in Clinical and Health Policy. JAMA. 2003;290(12): 1624-1632
In health care, evidence-based research is crucial. Nurses revolve their practice on evidence so that they may provide the best health care. Without research, there would be no evidence to prove health care related findings (Shmidt & Brown, 2012). With appropriate
The dark history of human experimentation began with the clarification between experimentation and treatment. The larger public began to notice experimenters ethical neglect for their subjects in the early 1960s. Those charged with administering research funding took note of the public furor generated by the exposure of gross abuses in medical research. These included uncontrolled promotional distribution of thalidomide throughout the United States, labeled as an experimental drug; the administration of cancer cells to senile and debilitated patients at the Brooklyn Jewish Chronic Disease Hospital; and the uncontrolled distribution of LSD to children at Harvard Medical Center through Professors Alpert and Leary. Most important was Henry Beechers 1966 article in the New England Journal of Medicine, detaili...
Reliability and validity are ways to demonstrate the trustworthiness in current research (Roberts et el, 2006). If healthcare professionals change their clinical practice based off research, then the results from the data should be honest and free from errors. Think about the implications, in my institution, we are ready to change the way we use Exparel in post–op pain management based of the data that I help collect with a resident over a two year period. We spent countless of hours not only collecting the data but analyzing with the help of a biostatistician and pharmacy to ensure that are numbers were correct. Our team knew that our results must be honest and trustworthy because patients care would be effected by our research.
However, as people think about animal rights, and the news that animals are suffering in the experiment, people began to consider stopping all animal testing. Animal testing should not be banned, because it both benefits humans and animals, especially the medical animal testing should be reserved. According to the book “Science, Medicine, and Animals” by the Committee on the Use of Animals in Research, National Academy of Sciences (1991), the animals also provide protection to a lot of endangered animals. Scientists can invent medicine, which is used to treat animal diseases, from animal experiments.