Welfare of patients

The na/ outcomes which are changes over time in the symptoms, welfare and quality of life of patients (and their families if relevant to the context), relative to some baseline position, standard or comparator. Final outcomes are clearly measures of effectiveness. They can equivalently be defined as reductions in need. 

The science of pharmacovigilance - monitoring and evaluating drug safety issues and communicating them effectively - is a vital activity of worldwide significance in the safeguarding of patient welfare and public health. Its clinical, public health and economic importance has been demonstrated, but it needs to be better understood and appreciated by politicians, the media and the public. 

Placing the welfare, safety and concerns of patients at the absolute centre of all thinking, planning and operations, and measuring the value of all activities against those nonnegotiable priorities by ... 

L D. There is always some degree of risk in clinical trials the object is to minimize the risk to the patient. The primary consideration in any clinical trial is the welfare of the subject. The safety of the drug is one objective for certain clinical trials as is the ef- 3. ficacy of the drug in other trials. 

The Food and Drug Administration relies on data that sponsors submit to decide whether a drug should be approved. To protect the rights and welfare of people in clinical trials, and to verily the quality and integrity of data submitted, the FDA s Division of Scientific Investigations (DSI) conducts inspections of clinical investigators study sites. DSI also reviews the records of institutional review boards to be sure they are fulfilling their role in patient protection. 

The positive aspects of molecular genetics and molecular pathology mentioned above need to be balanced with ethical concerns to safeguard the rights and welfare of human subjects (Sobel, 1999). The state and federal regulations protecting patient s privacy and welfare must be observed. 

The goal of the IRB (known also as the Independent Ethics Committee, or IEC) is the protection of the rights, safety, and welfare of human subjects involved in clinical research investigations. The review board is, therefore, primarily responsible for the evaluation of the proposed research. All evaluations should have the following objectives (a) to determine that the research is properly designed (b) to determine that the benefit of the intended therapy will outweigh the potential risk and (c) to determine that the patient will be provided with adequate information to enable him or her to make an informed decision regarding participation in the clinical trial. 

The primary reason for the presence of GCP is to safeguard human rights, as the welfare of current study subjects and future patients is at stake. Therefore, systems must be in place (such as ethics committee review and informed consent) to protect study subjects. Collecting honest and accurate data is also a major objective of GCP to ensure that data have integrity and that valid conclusions may be drawn from those data. Further, data should be reproducible, that is if the study were to be conducted in a similar population using the same procedures, the results should be the same. To assure the integrity and reproducibility of research... 

Scientific medical knowledge is indifferent to individual or collective human well-being it may be equally useful for biological warfare and the relief of human suffering. In contrast, the raison d Hre of clinical medicine is the welfare of the patient. 

In 1980, Health and Welfare Canada imdertook a retrospective review of case summaries of patients who had received essiac treatment. The study suggested that a majority of the patients showed no response to essiac. The small number of patients who had their disease stabilized were known to have also received some form of conventional therapy The essiac supporters were highly critical of this study. 

I. Protect the rights and welfare of the patients enrolled in the study... 

The first concern of the leadership of an accident victim is not the welfare of the patient, but rather the safety record (gathered from the medical department interview). 

Safety and security—Create contingency plans to ensure the safety and welfare of all patients, staff, and visitors during emergencies and disasters... 

We have described the epidemiology and health economic issues of LMV in Taiwan. Many challenges remain for the stakeholders and clinicians in designing and implementing a cost-effective health care system for LMV. Controversies continue regarding medical ethical considerations and the need to prioritize resource allocation. It is important to address these issues for the welfare of LMV patients to be fully achieved. 

Finally, highly technical, task-centered organizations can get caught up in paying less attention to the welfare of staff (and patients) than they do to getting the job done, where "the job" is understood in narrow, technical terms. This brings to mind the old saw, "It was a brilliant and masterful surgery. Unfortunately, the patient died."... 

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