Good Clinical Practice in health care research--论文代写范文精选

今天的医学实践是有数据来源的,对于同行评议报告,其中许多来自随机对照临床试验。随着临床试验的数量增加,新药物数量不断增加。发布的研究通常改变临床实践和一些具有里程碑意义的临床试验。下面的essay代写范文进行论述。

Abstract 
  Randomised controlled trials form the foundation for ‘evidence-based-medicine’, but the results of such research can be relied upon only if it was conducted according to principles and standards collectively referred to as ‘Good Clinical Practice’ (GCP). The GCP was established as a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid observations and sound documentation of research findings. It provides a framework for clinical investigators and pharmaceutical companies to conduct clinical trials according to similar rules and regulations, to ensure clinical research is consistently performed to high ethical and scientific standards and an assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Thus the GCP protects the rights, safety and well-being of subjects and ensures that investigations are scientifically sound and advance public health goals.

 Introduction 
  The practice of medicine today is driven by evidence: data derived from published, peer-reviewed reports, many of which come from randomised controlled clinical trials.1 In the past 30 years, the number of clinical trials has increased, consistently with the increase in the number of new drugs, devices and treatment strategies.2 Published research usually alters clinical practice and a few landmark clinical trials have resulted in major changes in medical practice.3 The increasing number of trials generated a need to ensure that participants in clinical trials are protected and that the data reported are valid.4 As a result, a standard international guideline named Good Clinical Practice was developed by the World Health Organization in the mid-1990s for this purpose.5,6

 What is Good Clinical Practice (GCP)? 
  Good Clinical Practice (GCP) is a set of guidelines that must be followed when conducting clinical trials to ensure that the rights and wellbeing of the trial participants are protected and that the data generated in the trial is valid.5,6 It is an international ethical and scientific quality standard for designing, conducting, performance monitoring, auditing, recording, analysing and reporting on clinical trials that involve human participants.5,6 The guidelines were developed in the mid-1990s in order to provide clinical trials with a unified standard across the European Union, Japan and the United States, and to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

 History of Good Clinical Practice 
  The guideline for Good Clinical Practice was developed in reaction to events or tragedies.5,6,7,8,9,10 For instance, between the 1950s and 1960s, thousands of children were born with phocomelia (seal limbs).10 This condition was then linked to the administration of thalidomide for the treatment of morning sickness. Another example comes from the Tuskegee trial.4 This study, which included men with syphilis, was sponsored by a government health agency. In the trial, some of the participants were given treatment and the others had no treatment. The untreated patients fared poorly and a significant number of patients died. These patients were not given any information and no permission was sought to withhold treatment. The investigators also had no clear endpoints.

  This resulted in litigation and financial settlements, and a public apology from a very senior government official in an international news network.4 Another famous example was ‘The Harvard Fraud’ of the 1980s.10 In this incident, a prominent senior researcher based at a reknowned institution trained and tutored a student. The student fabricated the study data, which was discovered because the data were ‘too clean’ The student was terminated from the institution and his licence was withdrawn. The outcome for the senior researcher and the institution included a written public apology, a retraction of papers and great embarrassment resulting from the questioning of the credibility of their past and future work.10 At the same time, the pharmaceutical industry was experiencing problems obtaining marketing authorisation for drugs in different countries.11 It was thought that this could be avoided by having a common clinical trial practice guideline. These events highlighted the worldwide need for a single, global, worldwide standard for the conducting of clinical trials, regardless of region, study design or study phase. 10

 Adverse events 
  The GCP also states that, if and when an adverse event or abnormality is identified, these events should be reported to the ethics committee and the sponsor of the research/clinical trial. In severe cases involving the death of a participant, the investigator is required to supply the sponsor and ethics committee with all the required information. The sponsor is then responsible for ensuring that all records and details pertaining to the adverse event are kept in proper order and submitted to the authority in charge of the clinical trial or to the Medicinal Evaluation Task Force.5,6（essay代写)

 Conclusion 
  As health care practitioners, physicians, scientists and researchers, we want only safe and effective treatments for our patients. Adhering to GCP is thus the best way to ensure this in a clinical trial and it is also in our patients’ best interests. The conducting of clinical research in accordance with the principles of GCP helps to ensure that the participants in clinical research are not exposed to undue risk, and that data generated in the research are valid and accurate. Thus the GCP not only serves the interest of clinicians and those involved in the research process, but also protects the rights, safety and wellbeing of subjects and ensures that investigations are scientifically sound and advance public health goals.（essay代写)

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