Issues And Management Of Clinical Trial

Issues And Management Of Clinical Trial

Introduction

In any type of business organizations, the management authorities are responsible for keeping in mind the ethical consideration as well as social responsibility in conducting their business. In certain type of businesses the ethical considerations are of significant importance. These businesses may involve the food manufacturing companies and the pharmaceutical companies in particular. The pharmaceutical companies face the major challenges of ethics and social responsibilities when they undergo a clinical trial of their new medications.

It is the increasing controversy about the ethics of clinical trials that are conducted by the pharmaceutical industries in the developing countries. The research conducted by many researchers have shown that the well known leading pharmaceutical companies undertake clinical trials of their manufactured medicines in the developing third world countries in order to research the effectiveness and side effects of the medicines. The clinical trials are conducted on many phases that involve the large number of participants form the developing and lower level income countries. Many of the times it has found that the clinical trials have negatively affected the participant patients, thus found that unethical clinical practices are being used in conducting trials.

When the medical researchers attempt to conduct the clinical trials, they have to face many critical challenges and ethical dilemmas. The first challenge they face is the adaptation of the procedure and methods they use in clinical trial and the drawing of the sample of the patients. The important thing is to consider whether the method of clinical trial is ethically acceptable or not. The most essential ethical belief in the pharmaceutical research is that the welfare of the patient is of important concern. However, in conducting the medical research the randomization between the treatments might be considered to be unethical. The other challenges the medical researchers face is that the patients might have possible side effects of the tested medicines.

Although the clinical trials are considered the best method to clinically test the effectiveness and side effects of the medicines upon the patients and to determine the benefits and potential harm of treatments. But on the other side the careful adaptation of the clinical research is the significant issue. The medical research studies conducted upon the animals gives no significant analysis to the researchers because there is the difference in the animal and human characteristics. Now most of the countries are conducting the medical researches upon the criminals that are in the death rows. Because those countries now consider that the criminals that are on the death rows have to die at any cost, so why should not they be use for the welfare of society. Also, those criminals are on the death rows who have committed a serious crime that violates the humanity, therefore using the criminals of death penalty without the consent of the criminals themselves is the best revenge of the society for them.

Discussion

In the given case, the pharmaceutical company, Novo Nordisk, is the manufacture of the insulin and ...