Can placebo be used as a control group in clinical trials?
A placebo is an inactive substance that looks like the drug or treatment being tested. Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance. In many trials, no one—not even the research team—knows who gets the treatment, the placebo, or another intervention. When ...
How do you evaluate the use of placebo in medicine?
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. People who receive a placebo are in the control group.
Is a placebo-controlled design scientifically necessary?
The use of placebo in children is more restricted than in adults, because children cannot consent. Placebo should not be used when it means withholding effective treatment, particularly for serious and life-threatening conditions. The use of placebo is often needed for scientific reasons, including pediatric trials.
What are placebos and why do we study them?
The use of placebo controls in clinical trials remains controversial. 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; …
Why would a study choose to use a placebo type of control group?
Researchers use placebos in the control group to determine if any differences between groups are due to the active medicine or the participants' perceptions (the placebo effect).
When would you use a placebo group?
A placebo is used in clinical trials to test the effectiveness of treatments and is most often used in drug studies. For instance, people in one group get the actual drug, while the others receive an inactive drug, or placebo.
Why is it better to have a placebo control group rather than a regular control group?
RATIONALE FOR PLACEBO AS A CONTROL GROUP First, the use of a placebo group in a double-blind, randomized, controlled trial is the most rigorous test of treatment efficacy for evaluating a medical therapy. Second, placebo-controlled trials can be conducted with fewer patients than active control trials.
Which group would you give a placebo treatment in an experiment?
Explanation: The control group in an experiment typically receives placebo treatments (in this case - Group E). Since all of the other groups are receiving at least one dose of the medication, they are considered to be experimental groups.
What is the advantage of using a placebo?
The major advantage of using a placebo when evaluating a new drug is that it weakens or eliminates the effect that expectations can have on the outcome. If researchers expect a certain result, they may unknowingly give clues to participants about how they should behave. This can affect the results of the study.Apr 25, 2021
Is a 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.Aug 11, 2020
Why a placebo control is important in intervention trials?
Among other rationales, placebos are effective in removing from the estimation of treatment efficacy the placebo effect: the tendency for a patient's condition to improve, not through a biologic mechanism specific to the disease pathophysiology, but because of 'less-specific' effects due to the patient's belief that ...Apr 27, 2012
Are placebos used for blinding or control?
Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further "natural history" group that does not receive any treatment at all.
What is a placebo group used for in scientific experiments?
A placebo is an inactive substance that looks like the drug or treatment being tested. Comparing results from the two groups suggests whether changes in the test group result from the treatment or occur by chance.
How is a placebo group used in an experiment quizlet?
How is a placebo group used in an experiment? - one group of subjects receives a treatment and the other group receives a fake treatment.
What is the placebo effect examples?
An example of a placebo would be a sugar pill that's used in a control group during a clinical trial. The placebo effect is when an improvement of symptoms is observed, despite using a nonactive treatment. It's believed to occur due to psychological factors like expectations or classical conditioning.Feb 25, 2019
Q. Why Are Some Cancer Researchers Now Using Placebos in Clinical Trials?
A: In past years, it was generally not necessary or possible to use placebos in cancer clinical trials. This is because most chemotherapy treatment...
Q. Why Are These Clinical Trials Necessary For The Advancement of Cancer Research?
A: The fastest way to improve access to new cancer treatments for all patients is the timely completion of well-designed, definitive clinical trial...
Q. How Can The Design of A Clinical Trial Address Some of The Ethical Concerns Around Using Placebos?
A: Placebos should be used in cancer clinical trials only when(1) it is scientifically necessary,(2) ethically appropriate,(3) and when patients ha...
Q. What Are Some Examples of When It Is Not Appropriate For A Person With Cancer to Participate in A Placebo-Controlled Trial?
A: Placebo-controlled trials are never appropriate when a highly effective or potentially curative therapy is available for a patient. An exception...
Q. What Questions Should Patients Ask Their Doctor About Placebo-Controlled Clinical Trials?
A: The main questions that patients should ask are about their treatment options. If a patient has already received all known, effective therapies...
What is a placebo controlled trial?
A placebo-controlled trial compares a new treatment with a placebo. The placebo is usually combined with standard treatment in most cancer clinical trials. People who receive a placebo are in the control group. The use of placebos in cancer clinical trials is rare. When a placebo is used in a study, it is done with the full knowledge ...
When is it not appropriate for a person with cancer to participate in a placebo controlled trial?
What are some examples of when it is not appropriate for a person with cancer to participate in a placebo-controlled trial? A: Placebo-controlled trials are never appropriate when a highly effective or potentially curative therapy is available for a patient.
How can we improve access to cancer treatments?
A: The fastest way to improve access to new cancer treatments for all patients is the timely completion of well-designed, definitive clinical trials that provide evidence of the safety and effectiveness of a new drug and lead to marketing approval . In some circumstances, such clinical trials may require the use of placebo controls ...
How to use a placebo?
Use of placebo controls may be justified in these situations: 1 To prove effectiveness of a new treatment for diseases with high placebo response rates 2 In conditions that alternately become worse or better, have spontaneous remissions (the disappearance of the signs and symptoms of cancer, but not necessarily the entire disease), or have an uncertain and unpredictable course 3 When existing therapies are minimally effective or have serious side effects 4 In the absence of any effective therapy
What to ask patients when a placebo is administered?
If a placebo is administered as part of the trial, patients should ask whether there will be an opportunity to receive the study drug at any point in the trial, if not immediately upon enrollment. Clinical Trials. Drug Discovery and Development.
Why is it important to compare a new drug to a placebo?
Because new drugs are often tested in patients who have already received all known, effective treatments, comparing a new drug with a placebo may be appropriate and allows researchers to easily and definitively determine the good and bad effects of the new drug. Q.
What should patients know about clinical trials?
If participation in a clinical trial is an option, patients should understand the rationale and goals of the trial, whether it involves use of a placebo, and the likelihood of receiving the drug being studied or a placebo. It is also important to ask about the likelihood of benefit from the investigational treatment and the potential side effects.
What is phase 1 in clinical trials?
Phase 1 trials are the first of four phases that make up a typical clinical trial progression. Phase 1 trials are typically not placebo-controlled, often involve healthy volunteers, and are not designed to measure efficacy or really powered to involve statistical testing at all.
What is compassionate use?
Compassionate use of unapproved drugs, or off-label use of drugs approved for other indications, is sometimes an alternative to clinical trials in trying new treatments. When no known treatment exists or when other treatments have failed in a given patient, a treating physician can have broad discretion in treatment on their own, rather than under the umbrella of a clinical trial. Data from compassionate use isn't typically used to support drug approval - there are substantial ethical concerns - but it can be used to motivate further research and other physicians may use positive reports from compassionate use cases to try the same treatment in their own patients. This is the scenario closest to the urgent situation you describe.
Why is a placebo used?
Used appropriately, a placebo control can provide valuable data, particularly when there is no accepted therapy for the condition under study. The existence of an accepted therapy does not necessarily preclude use of placebo controls, but because use of a placebo deprives participants in the control arm of access to accepted therapy ...
When is the use of a placebo justified?
Use of surgical placebo controls may be justified when: An existing, accepted surgical procedure is being tested for efficacy.
What is a placebo in surgery?
A new surgical procedure is developed with the prospect of treating a condition for which there is no known surgical therapy. In such cases, the use of placebo must be evaluated in light of whether the current standard of care includes a nonsurgical treatment and the risks, benefits, and side effects of that treatment.
What is the fundamental requirement of biomedical and health research?
A fundamental requirement of biomedical and health research is that it must provide scientifically valid data. In some research, this can best be achieved by comparing an intervention against a control to identify the effects of the intervention. Used appropriately, a placebo control can provide valuable data, particularly when there is no accepted ...
Is a placebo control ethically justifiable?
Placebo controls are ethically justifiable when no other research design will yield the requisite data. Assess the use of placebo controls in relation to the characteristics of the condition under study in keeping with the following considerations: Studies that involve conditions likely to cause death or irreversible damage cannot ethically employ ...
Can you use placebo for severe illness?
Studies that involve illnesses characterized by severe or painful symptoms require a thorough exploration of alternatives to the use of a placebo control. In general, the more severe the consequences or symptoms of the illness under study, the more difficult it will be to justify the use of a placebo control when alternative therapy exists.
Can a placebo be ethically justified?
Consequently, there will almost certainly be conditions for which placebo controls cannot ethically be justified. Design studies to minimize the amount of time participants are on placebo without compromising the scientific integrity of the study or the value of study data.