CLINICAL TRIAL

Clinical trial



Clinical trial

Introduction

A clinical trial is a research study or protocol done in humans to evaluate the result and value of treatment with a control. Control means there's no treatment given, only an excuse or standard treatment. Clinical researchers conduct clinical trials.(Senn,2000,142)

Question 1

The feasibility of clinical trials depends, among other factors, on the number of eligible patients, the recruitment process, and the readiness of patients to participate in re- search. Generally, not more than 5% to 10% of patients who are screened for large, multicoated trials on affective disorders and schizophrenia are recruited (1). Greil and others have shown that a large number of patients may not participate in a trial for reasons other than the formally stated inclusion and exclusion criteria. (2). One of the major obstacles to inclusion may be clinicians' belief that the research is intrusive.(Curvers,2000,2036)

They often may overestimate the negative effects from participating in research, compared with patient perception. Although the selection and the recruitment process of patients is of crucial importance for evaluating the generalizability of the results obtained in clinical trials, until now only sparse attention has been directed to these topics. Seeking patient views about their experiences in research projects may allow investigators to identify areas of research that are important to patients, to question how patients' experiences may affect research outcomes, and to develop more effective recruitment and retention strategies. The objectives of this study were to evaluate the general readiness of psychiatric inpatients to give their consent to different forms refusing a hypothetical participation.

Most patients trust them when they feel ambivalent about participation and would rely on their decision, Clinical research is fundamental for improving treatment. The larger the population studied and the wider the range of patients included, the more likely it is to lead to findings that are applicable and relevant to most patients. Although it is fundamental to allow patients to make an autonomous decision about their participation in a research project, it is also important not to decide for them by assuming that they would, or should, refuse to take part.(Mellman,2001,219)

Question2

The Medicines and Healthcare Products Regulatory Agency (MHRA) is a government agency that issues licenses for all drugs and medical devices in the UK. Without a license from the MHRA, a drug cannot be sold or prescribed in the UK.

The MHRA ensures all medicines and medical devices work and meet acceptable standards on safety, quality and effectiveness. (Senn,2000,142)

Although no products are risk-free, the MHRA makes judgments based on evidence from clinical trials to make sure the benefits to patients justify the risks:

Are the advantages of taking it greater than the disadvantages?

Are the side-effects acceptable?

Does it do the most good for the least harm for most people who will take it?

Anyone who wants to trial a new drug in the UK has to get permission from the MHRA. They have to meet strict safety criteria and send a report to the MHRA showing:

how well the medicine works

its side-effects

what it contains

how it works in the body

who and ...