StudentShare solutions
Triangle menu

Clinical Trials - Essay Example

Not dowloaded yet

Extract of sample
Clinical Trials

Schedule 1 (Regulation 2[1]) Part 1 of the Regulations specifies the application and interpretation of the conditions and principles of Good Clinical Practice (GCP) and also refers to the Declaration of Helsinki adopted by the World Medical Association (WMA) in June 1964. Part 2 of this schedule in the Regulation states the principles and conditions that apply to all clinical trials and that are based on the principles of ICH GCP, whilst Part 5 specifies the conditions and principles which apply in relation to an incapacitated adult (Statutory Instrument 2004).
"A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form."
As the patients will be unconscious in this trial they will be considered to be physically incapacitated adults under the governing Regulations, and therefore unable to give informed consent. First of all informed consent in this group of subjects can only be considered if the subjects are able to benefit from research that can improve their condition. ...Show more

Summary

The Medicines for Human Use (Clinical Trials) Regulations 2004 (the Regulations) regulate clinical trials in the UK since they came into force in May 2004. These regulations replaced the provisions of the Medicines Act 1968 and transposed the EU Directive on Clinical Trials (Directive 2001/20/EC) into UK law…
Author : felixrobel
Clinical Trials essay example
Read Text Preview
Save Your Time for More Important Things
Let us write or edit the essay on your topic
"Clinical Trials"
with a personal 20% discount.
Grab the best paper

Related Essays

Clinical Trials
Clinical trials are biomedical and health-related research studies on human beings following a pre-defined protocol. Clinical trials are categorized into two: interventional studies and observational type of studies. Interventional studies involve research subjects selected by the investigator.
1 pages (250 words) Essay
Clinical Trials, HIV/AIDS Vaccine and the Vulnerated
The first two decades following the identification of HIV/AIDS, the global community has taken no vigorous or categorical approach in addressing the pandemic. This circumstance has resulted in a situation wherein low and middle-income countries witnessed not only the increase in the global burden of the disease, but also the increase in the number of their people afflicted with HIV/AIDS (UNAIDS, 2011).
6 pages (1500 words) Essay
Randomised clinical trials
Ultimately various methods to determine sample size for a randomized control trial have been studied and illustrated with examples. Internet has been the primary source of information for this report. Several journal articles were accessed from the Liverpool Metalib, few others were open access and some required registration.
19 pages (4750 words) Essay
Clinical trials for intiviral in general
This is known as clinical data management, which is an integral component of the drug development process. The conclusions derived from data analysis are the basis of for regulatory approval and subsequent
2 pages (500 words) Essay
Clinical Trials: Ethical or Deceptive
Apart from that, some subjects only take part because of their own benefits and not the good of the society. These form the major reason behind ethical issues, but concerned parties are making efforts to set things straight. This paper looks into
4 pages (1000 words) Essay
New Pharmaceuticals (FDA's role in approving new drugs)
One of the most important factors in the approval of a new drug is the clinical trial, a process in which the new drug is vigorously
2 pages (500 words) Essay
What is the current status of clinical gene therapy trials for Chronic Granulomatous Disorder
ns of the disease further reflect in the ‘inability’ of phagocytes to make ‘reactive oxygen species’ because of the lack or malfunction of NADPH complex, and thus the ‘susceptibility to infection increases’ in the affected population (Kepenekli 2014: 1). Evidence
6 pages (1500 words) Essay
CLINICAL SIGNIFICANCE
The use of confidence interval is an obvious alternative to using hypothesis testing and usually gives a range of suitable values to support the results. The confidence interval acts as an inferential perspective for clinical trials. Firstly, while conducting clinical
1 pages (250 words) Essay
Critically discuss why a clinical trial protocol is essential in clinical trials
otocol is a quality measure and that it ensures that there is consistency in results, others feel that the occasional amendment of such protocol shows the subjective nature of such protocols. However, there is a point of concession that standardizing clinical trial procedures
2 pages (500 words) Essay
Biomedical Informatics
In this context, Six Sigma seeks to play a significant role in improving the quality and efficiency of diverse clinical trials. Indeed, the Six Sigma strategy focuses on making different processes more homogenous and specific
4 pages (1000 words) Essay
Get a custom paper written
by a pro under your requirements!
Win a special DISCOUNT!
Put in your e-mail and click the button with your lucky finger
Your email
YOUR PRIZE:
Apply my DISCOUNT
Comments (0)
Rate this paper:
Thank you! Your comment has been sent and will be posted after moderation