What are placebos in clinical trials?

A placebo is an inactive drug or treatment used in a clinical trial. It is sometimes referred to as a “sugar pill.” A placebo-controlled trial compares a new treatment with a placebo. The placebo is usually combined with standard treatment in most cancer clinical trials.

What is the purpose of a placebo in an experiment?

Researchers use placebos during studies to help them understand what effect a new drug or some other treatment might have on a particular condition. For instance, some people in a study might be given a new drug to lower cholesterol. Others would get a placebo.

Is it ethical to use placebo in clinical trial?

The World Medical Association has reaffirmed its view that in general it is ethically unacceptable to conduct placebo controlled trials if a proven therapy is available for the condition under investigation.

Why are placebos unethical?

Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit.

How do you explain a placebo?

A placebo is any treatment that has no active properties, such as a sugar pill. There are many clinical trials where a person who has taken the placebo instead of the active treatment has reported an improvement in symptoms. Belief in a treatment may be enough to change the course of a person’s physical illness.

Is placebo a control group?

In order to make sure a new drug or vaccine is effective, studies often use a placebo or control group. Placebos are “sugar pills” or “dummy drugs” with no active ingredients and are made to look like the real medicine. A control is a standard treatment (that may be currently used) for the illness.

When Should a placebo be used?

Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there …

Is it ethical to use a placebo?

Placebo use, however, is criticized as being unethical for two reasons. First, placebos are supposedly ineffective (or less effective than “real” treatments), so the ethical requirement of beneficence (and “relative” nonmaleficence) renders their use unethical.

Is giving a placebo illegal?

Prescribing placebos is not illegal, but can be unethical if recipient has no idea that he or she is getting a sugar pill.

Is it unethical to give a patient a placebo?

It is generally agreed that placebo is unethical when its use is likely to result in irreversible harm, death, or other serious morbidity.

Why does the placebo effect happen in a clinical trial?

The placebo effect can happen for many reasons during a clinical trial. For example, patients who already believe in a particular treatment, such as stem cell therapy, are more likely to sign up for a study involving it.

Do you have to stop therapy if you are in a placebo group?

In many cases, patients will not have to stop their current therapy if they’re placed in the placebo group (so the patients will not be receiving no treatment at any given time).

How is osimertinib randomized in the adaura study?

Patients will be randomized 1:1 to receive osimertinib 80 mg once daily or placebo once daily until disease recurrence, a treatment discontinuation criterion is met, or patients achieve the maximum treatment duration of 3 years. The primary endpoint of this study is disease-free survival.