I believe placebo-controlled trials are indeed beneficial and in some cases, necessary in certain developments. I believe, for instance, drugs and treatment that involve improving ones mental state would find it very beneficial to conduct PCT's. It would be beneficial because the way our emotions, as well as physical bodies, respond to the wide variety of sensory input we experience on a daily basis is too complex to fully understand. Therefore, if a patient were to receive a placebo treatment, it very well may improve their mental, and even physical state. Being able to obtain statistical evidence to determine the true effectiveness of a drug is obviously very important to a pharma company and therefore implies that PCT's are indeed necessary in many cases. However, conducting PCT's does indeed bring up ethical issues. To obtain accurate data with PCT's, both subject groups must have the same illness or condition. In addition, to avoid compromising the data, both groups cannot be told whether they received the real drug or the placebo. Therefore, there will be ill subjects that will receive a placebo treatment. In my opinion, treating subjects case-by-case is the best anyone can do. For instance, perhaps giving the subjects that are in a greater need for recovery than others should receive the real drug. However, I'm sure this may alter the results from as accurate as possible. It is important to note, however, that the drugs that undergo trials are still under development and should not be considered as a promising resolution to begin with, whether a subject received the real dose or not.

I think placebo group is the only scientific way to prove a drug is actually working on the human body. Since it is no longer a mystery that a psychological effect called "placebo effect" is proved to be statistically effective for relieving symptoms of a disease, we will never know this drug is effective because of this effect or it actually does something in the body to make things better. This placebo effect must be excluded to explain the results of a drug in clinical trials. As for the ethical issues, I don't think of this as a real thing since in most cases, subjects are mostly made of those who are eager to find out the solution of their diseases, and the status quo of medicine knowledge cannot cure them, under such circumstances, the developing drugs are coming for the purpose of pushing the frontier of the battle to that disease a step further, before that, nobody can get a better drug. Besides, as long as the informed consent form should cover how placebo group works and why this should be set as confidential, it should not be considered as a way of "cheating or decoying" people into such experiment.

Placebo controlled experiment is a study where controlled group is given a placebo while another group is given the drug that is being tested. This way the results can be compared with the placebo group. Placebo is meant to look just like a treatment or medicine, but in reality is not. It is just a look-alike treatment. All test subjects in a clinical trial must be informed there is a chance they could be in the group receiving the placebo. However, they will not know if they are receiving the placebo. The placebo controlled experiments are intended to avoid biases as well as the expectation mitigation.

There are ethical issues when applying a placebo in a clinical trial. It becomes a case of what's better for the greater good. Would you rather save a small group or the population as a whole? The group getting the placebo has little potential to be cured compared to those receiving the actual drug but if the drug works, then all of the population with this illness can be cured. I believe it's a necessary evil as these are just the risks involved with clinical trials. By applying these placebos, a control group is possible and it allows for the research of the effect of the drug on humans while mitigating bias. If the drug doesn't work then the results will just be similar to the placebo group, but the researchers will have data to improve upon the drug.

My example is more pharmaceutical related but this can be the same case for medical devices.

As much as it feels like they should unethical, I believe placebo controlled trials are necessary, especially in the case of new drugs. They are needed to tell if the new drug is actually effective when compared to something the investigators know has no real effect. The ethical question of course is it ethical to give someone a drug you know will not actually help them. In the long run I think it is. Sometimes sacrifices have to be made. In my head it comes down to which is worse, not fully treating someone who knew the risks when they started the trial, or releasing a drug the potentially will not be as effective as the researchers believe. To me it is much worse to release that drug without knowing its true efficacy than it is to use a placebo in testing. Now this does rely on those conducting the test to make sure that those who enroll in the clinical test are aware that they may be given a placebo. It is also important that this test be a double blind study so neither the testers or the patients know if they were given the placebo or the active treatment. This prevents any bias from coming into play.

So I ask my classmates which is more ethical: giving someone a placebo or releasing a drug that does not have a comparison to a true control?

I believe placebo-controlled trials are very necessary. There is something known as the placebo effect which is when a placebo drug or treatment is not due to the actual drug/treatment but due to the patient's belief. If patients knows what type of treatment they are about to receive, they may convince themselves that it is actually working. I do believe that it should be necessary for non-life threatening disease/illness and not if the person has something severe. An example of something severe would be like cancer. The reason for this is because it may discourage that person.

Placebo-controlled trials are used widely in the development of new pharmaceuticals. The concerns about the use of placebo-controlled trials are not uniformly unethical when known effective therapies are available, rather their approval is determined by whether the patient will be harmed by the extension of therapy. In my opinion, if patients are not harmed, then such trials can ethically be carried out. However, placebo-controlled is not acceptable or say unethical when patients are being treated with an existing therapy. In the end, it is upon the patient to make a decision whether they are ready to be involved in trials.

Placebo controlled trials are necessary for research trials and I don't believe that it's unethical. The ethical question of course is it ethical to give someone a drug you know will not actually help them and the answer is yes. I believe that they are ethical because it compares with the standard treatment and it give opportunity to compare the results. This can also help the clinician determine the relevance of the clinical trials to the objective. he disadvantage of using a PCT is that certain patients will not receive the treatment they need. Another disadvantage is that if the doctors do not know who actually received the placebo in a double blind experiment then they may not be able to give the proper assistance to their patients.

For certain experiments, I think placebo controlled trials are beneficial in helping researchers investigate the affects of a drug. Placebos are usually used in comparison to the experimental drug and act as a control. Say for example there is this new drug that can alleviate the effects of a migraine. An ideal study would be to have subjects either take the experimental drug or a placebo (most likely a sugar- pill) after an onset of a migraine. The researcher/investigator can then look at the observations made by the subjects and compare the affects of the placebo and experimental drug. Because the placebo acts as a control, there should be no relieved symptoms after using this pill, making it ideal for a comparison.

Placebo of clinical trials are ethically acceptable provided that patients receiving placebo are not at risk for serious harm and give informed consent

I have heard of a situation where participants of a pharmaceutical cancer trial got together in a room following a group informed consent session and combined their meds and then divided them out so that all the members of this group would have an equal fraction of the active ingredient. This is possible for rare diseases where members are part of a support network. Perhaps this says something about a flawed information session process (although the research scientist was a very reputable scientist in the RCT arena), but it is also an interesting comment on peoples need to do something that might give them an advantage with their disease.
I guess the question is whether there are any alternative options to a placebo controlled trial that might still provide useful information. Does one need to wonder that if the difference from the current best treatment is so small for a new drug that it cannot be ascertained that it is really worth pursuing, unless there are other benefits such as reduced side effects? I am not an expert in randomized clinical trial (RCT), but that would be my question. Would not selection bias also be a problem if those responding to conventional therapy are less likely to risk missing out on this to go on a placebo controlled trial versus patients who are not responding to normal therapy, who are more willing to try for any chance of improvement.

Posted by: merzkrashed

As Dr.Simon mentioned about placebo-controlled trials, which is A “dummy” device or drug is used on one group of patients and compared to patients with the real one, or sometimes called a ‘sugar pill. Or a fake ultrasound device in a bone healing study.

So, Do you think Placebo-controlled trials: Are they ethical? Are they necessary ? Also, what are the advantages and disadvantages of using PCTs ?

I think PCTs is rarely used in some circumstances like asthma patients for example. The advantage of using PCTs is Zero risk of overdose.Also, Placebos are always better than no treatment.

So, What are your thoughts about placebo controlled trials ?

I believe that placebo-controlled trials are both necessary, as well as ethical, given that the subject is not put at serious risk by not receiving treatment. I think one of the main benefits of PCTs surrounds the ability to isolate whether improvements in a course of treatment are from the treatment itself, or from other factors, such as the perception of being treated. One disadvantage to PCTs is that by nature of the study, not everyone who needs treatment is given treatment. In a study of anxiety, receiving a placebo instead of the main treatment would not likely cause any life-threatening complications. If the same were applied to an insulin study on diabetics, the risk of complication (and questions into ethicality)  increases significantly.

So what would some examples be where you would NOT want a placebo in a device trial?

Personally I believe it is unethical to use placebo controlled trials, but they are a necessary evil. If we go back and look at the the Tuskegee Syphilis study the subjects were told they were being treated for their ailment but they were actually just being studied not cure nor research for the patients benefits were actually performed. But there are real physiological experiences that can affect the study in a negative way where the result will seem hyper positive and not truly reflect the true results. So saying they are 100% ethical would be misleading some people are earnestly looking for a cure to their ailment but they are mislead even if they sign a waiver.

Placebo-controlled trials are the trials where we place a dummy device on a group of patients randomly selected individuals.
I feel it is ethical and is necessary for studies as mentioned by Dr.Simon in his video that the information provided to the patient might impact the overall result.
I don't see a disadvantage to this type of trial as we need a control group for study and this group will be the one for the study.
But at the same time, I feel it is unethical to do so to the group involved in the trial.

PCTs are definitely ethical and necessary. The placebo effect is real so to ensure that it is not what is making the cause of a change in a person's health due to a medical device or drug, it needs to be implemented. They are ethical because every participant knows that there's a chance that they could be given a placebo, and the placebo doesn't hurt them so there's nothing wrong with that. I don't think that there are any disadvantages of using PCTs but the benefits would be more certainty that a drug or device is working as expected, and the patients who get placebos may experience some relief of symptoms as well just because of the placebo affect on their body.