Ethically, the health care professional has a responsibility to provide the best

Question

Ethically, the health care professional has a responsibility to provide the best care (beneficence), minimize harm, respect for persons (informed consent), and treat people equally (justice). Does the act of enrolling a person in a randomized clinical trial counter these obligations? What are the implications for the patients in the placebo group? What are the implications for the patients in the experimental groups? Consider the following: A new cancer drug has been developed and is ready for clinical trials. The researcher has received IRB approval and informed consent is obtained. This new drug appears to be much more effective than the standard protocol. A randomized clinical trial is conducted with 50 patients assigned to the experimental group (the new drug) and 50 patients assigned to the control group or usual treatment (standard protocol). In the course of the clinical trial, the patients in the control group experience a significant increase in mortality rates compared to the experimental group.

A) Write a potential hypothesis for this study and identify the variables (independent and dependent)

B) Should the research study be stopped? Why or why not?

C) Is there a favorable balance between benefit and harm?

D) What would you recommend from an ethical perspective? Support your position.

Explanation / Answer

In the randomisation the patients were divided into groups in which one group will be receiving new treatment and the other has standard treatment people having the standard treatment are called control group and a randomised trial that has this control group is called randomised controlled trial sometimes people in the control group take dummy treatment called placebo. A placebo is used when there is no standard treatment available the patients in the control group would not receive any treatment so it is not a pickle to give a placebo to a group of people who really are in need of the treatment so the research ethics committee will not give permission for such a trial design.

The randomised clinical trial has 4 elements they are the use of control patients who receive different treatments like the conventional or a placebo number to the use of random assignment of treatment to be tested number 3 the avoidance of investigated by us buy single or double procedure number 4 the development of a sound ethical basis for carrying out the research.

Randomised treatment in real life is a complex one but the process is like a tossing a coin the most important advantage of randomisation is that it minimises allocation bias balancing the known and unknown prognostic factors in the treatments.

Although although informed consent is provided before participation but it is believed that the patient must receive best treatment personally and they should understand the difference between Research and treatment.

This type of treatment should be stop really if there are expected benefits of arms or in the case investigator signs that there will be no difference between experimental and control interventions. Moreover maintaining data for this type of treatment is expensive and that needs extremely large sample sizes.

Ethical link is necessary to banish randomised clinical trials premature release and the agreement of patient 2 with holder in innovation from the control group in the future treatment may not be feasible there are some cases in which the previous treatment data is exploited to reduce the sample size but these approaches for controversial.

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