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Placebo-controlled trials: Are they ethical? Are they necessary ?

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 hv42
(@hv42)
Posts: 42
Eminent Member
 

I think Placebo-controlled trials is ethical and necessary because Using placebos in clinical research helps scientists more clearly understand whether a new medical treatment is safer and more effective than no treatment at all. This is not always easy because some patients get better in a clinical trial even when they don’t receive any active medical treatment during the study. And also in order to best determine whether a new medical treatment is safe and effective, PCTs is necessary for researches to perform, which will allow the researchers to gather meaningful and useful scientific information about the safety profile of a new therapy and its effectiveness in treating a specific medical condition. I think it PCTs has balance of advantage and disadvantage because we don't know what would be the out come of the drug because every both react differently to the drug, disadvantages for the first people using drugs maybe they do not have the best doses, or that they risk resistance if other newer drugs aren’t allowed in the study. The advantages may be that despite these problems, the drugs have still been life-saving, and the person is still alive to benefit from the next drugs in the system.

 
Posted : 29/10/2017 11:15 am
(@dh239)
Posts: 39
Eminent Member
 

Placebo-controlled studies are a necessity when it comes to establishing the efficacy of a drug, however, their ethical foundation comes into question when a placebo is given instead of an established treatment. This would be like giving a diabetic a placebo to control for the testing of a novel drug while there are already other, effective drugs on the market. In these cases, I feel it is wrong to use a placebo because it poses a risk to the patient's health. However, when there is no such risk, and the subjects are informed that there is a possibility of them receiving a placebo, the ethical issues are minimized. When there are alternative treatments available, they should be used as the benchmark rather than the placebo.

 
Posted : 29/10/2017 12:35 pm
(@tilak)
Posts: 24
Eminent Member
 

Placebo controlled trials are a great way of helping scientists understand why a new medical treatment is more useful and effective than no treatment at all. Due to the "Placebo effect", some patients may progress and get better without receiving any treatment at all, therefore lowering the accuracy of these trials. Nevertheless, because of this affect, researchers have seen that many patients improve due to psychological reasons without receiving any treatment. As a method of determining if a new drug or treatment is safe and effective, researchers compare the results to that of the impact of the Placebo of that treatment. This helps professionals collect data on new types of therapies and its effectiveness in treating specific medical conditions. For safety reasons, Placebos are not used in trials where patients have life threatening illnesses or if a established cure or treatment already exists. At times, the FDA may request the use of a placebo to prove that a new drug or treatment is safe and effective. In all clinical trials, volunteers who receive a placebo get the same attention, care and monitoring as those who have received an actual drug or treatment. Placebos offer a very direct approach in studying new medicines.

References:
http://hsro.med.miami.edu/documents/What_is_a_Placebo_Controlled_Clinical_Trial.pdf

 
Posted : 29/10/2017 1:35 pm
(@bjv9)
Posts: 61
Trusted Member
 

Placebo-controlled trials are very important in establishing efficacy and statistical significance during the development of a medical device or drug. It should also be noted that a placebo doesn't necessarily mean that no treatment is given to an individual in need of treatment. It simply means that where an investigational intervention may be provide within the structure of the standard of care, a placebo/blank is given. As an example, the Merck V710 Staphylococcus aureus vaccine underwent a phase 2B/3 clinical trial in which the vaccine was matched against a placebo control population. The study found that the vaccine actually was far more dangerous than the placebo in the population that developed postoperative S. aureus infections with a specific interleukin profile. As such, the trial was immediately halted and the vaccine was returned to the development pipeline. The placebo control was critical in establishing the efficacy, or in this example, the lack of efficacy of the vaccine. As such, placebo control is important in clinical research.

 
Posted : 29/10/2017 2:02 pm
(@sahitya-sadineni)
Posts: 69
Trusted Member
 

Placebo controlled trials are needed for clinical trials and they are ethical. As humans, we tend to overthink and overanalyze situations when it is not needed. Most of the placebo trials are done because we feel that medication will help us when we take the pill. For instance, if we are told we will be given a pill that is supposed to make us more energetic and after taking it you think you feel more energetic. But that pill was a placebo one. Psychology places a huge role in what we feel.
Also placebo pills will act as a control in the trial so it is there so compare results.

https://www.cancer.net/research-and-advocacy/clinical-trials/placebos-cancer-clinical-trials

 
Posted : 29/10/2017 5:10 pm
(@puneet)
Posts: 80
Trusted Member
 

I think that placebo controlled studies are ethical and also very important in clinical trials. Placebo studies are important to the study because they can be compared to the results of the drug and without any other factors differing besides the drug show the true difference that the drug makes, if it makes any at all. From an ethical standpoint it may seem unethical for certain subject suffering from the same disorder as the other subjects to be given the placebo instead of the actual drug, but subjects are warned of this beforehand.

 
Posted : 29/10/2017 6:21 pm
(@woolynn)
Posts: 36
Eminent Member
 

In my opinion, that Placebo-controlled trails are respected for patient autonomy. Patient must be informed and choose without coercion. The beneficences are provider should look out for the best interest of
the patient and the potential benefit to the patient supersedes. The investigators' scientific interests are informed consent participants must be informed about the rationale for the trial and must understand that they may be assigned to a placebo condition. What else, participants must be informed of any risks of
the interventions and the risks associated with delaying treatment if assigned to a placebo condition.

The advantages are The main advantages are:
Information on the possibility of patenting a technical solution which is disclosed in the international application prior to its submission to national patent offices; Significant extension of the allowed term for application submitting to national patent offices as compared to traditional (Paris Convention) and regional procedures.

There are also disadvantages:
One of the main problems with the PCT is that it does not specifically provide for top-up searching, or allow applicants to request searches from more than one International Searching Authority. Since the ISR is prepared prior to publication, there is the potential for additional relevant patent applications to be published subsequent to the preparation of the ISR. Since there is always the potential for different patent applications covering the same inventions to be filed in similar time frames, it will always be necessary for a top-up search to be completed. If this is not included as part of the PCT procedure, then it must be performed by the national offices. It must also be acknowledged that it is unlikely that a single search will identify all prior art relevant to a particular invention. This is illustrated by the frequency with which prior art is revealed by searching conducted by national offices post national phase entry. Further problems with the PCT for applicants appear to have been introduced with the enhanced international search and preliminary examination system due to commence next year. Under the new system the applicant may have no opportunity to enter into a dialogue with the searcher or examiner to formally contest an adverse patentability finding of the ISA, even if a Demand is subsequently filed. According to the new procedure there is no opportunity to formally respond to the Written Opinion on patentability issued by the International Searching Authority. If a Demand is filed, this report is treated as the first Written Opinion for the purposes of International Preliminary Examination, and the new procedure appears to allow the IPEA to immediately issue an IPER without any dialogue with the applicant. With the 10 month extension of national phase entry on filing a Demand removed, and the prospect of gaining little value from a Demand under the new system high, there is a strong possibility that the number preliminary examinations performed by IPEAs will decrease substantially. This is an unfortunate outcome for the PCT itself, as well as for national offices. While the workload in the IPEA may be reduced in the short term, overall the amount of examination work being done on each family of patent applications by national offices will increase substantially.
A further problem with the PCT is the lack of quality control in relation to international searches and IPE. A poor search or poor examination can have disastrous consequences for the applicant, and can increase the workload at the national offices, or alternatively, result in the grant of overly broad patents. This is problematic for both the applicant and for third parties.

 
Posted : 29/10/2017 6:23 pm
(@williamzembricki)
Posts: 64
Trusted Member
 

For a study to be considered to have followed the scientific method it must have an experimental and a control group. It is sad to know people are being told they are being treated but they are actually reviving no treatment at all. This is one of the risks you ensue when you agree to be part of an experimental drug study. The removal of the Placebo would ruin the advancement of modern medicine. The placebo effect is very strong and would cause for falsely approve medications that may not actually work. The studies that occur today has pass fail ratings based on the differences between placebo and experimental. The issues with placebos is understandable but the removal of placebos is not currently possible in medicine. There would have to be a complete reformatting of clinical research.

 
Posted : 29/10/2017 6:37 pm
(@monicagoncalves)
Posts: 59
Trusted Member
 

A placebo-control group is when half of the participants are given the medication, and the remaining participants are given a placebo. A placebo is an inactive substance that looks identical to the medication. By utilizing a placebo, the study remains free from being altered as neither the participants nor the researcher knows who is receiving the medication. This provides valid and reliable results.I think that placebo-controlled trials are ethical and necessary in any clinical trial. They are necessary and have the advantage of providing the experiments with a baseline or control group to compare to the active drug that is given to the other group. Without a control group, researchers cannot accurately compare there drug.For a study to be completed with scientific integrity is must have some form of a control- hence I do not see the placebo-control group as being something unethical or unnecessary. `

 
Posted : 29/10/2017 7:00 pm
(@jjp93)
Posts: 79
Trusted Member
 

I believe there is a certain extent to where the placebo controlled trails are ethical. They are a “sugar pill” that sometimes can convince the human body to fix the problem itself but some diseases do not just fix itself. Sometimes clinical trials that require a placebo means that the patient does not get all the approved treatment that they could have received if they didn’t do the clinical trial. Depriving the patient of approved treatment that could help them is unethical because the patient wants some type of treatment given to them during the clinical trial. The patient looks for clinical trials because they want another option to help fix their disease and usually it’s their last chance so not giving them the treatment would mean they wouldn’t be getting better. I also do believe that placebo controlled trials are necessary because they determine whether or not the clinical trial works or if it’s just the patient thinking they’re getting better and feeling better. The advantages are that the patient has a better chance of getting better if they get the actual treatment but the disadvantage is if they get the placebo, they might not get better.

 
Posted : 23/10/2018 7:31 am
(@msc52njit-edu)
Posts: 78
Trusted Member
 

Placebo controlled trials are ethical if the individual who is not receiving the correct treatment, is not in serious danger regarding their health. They are also ethical because all individuals have to sign an informed consent form beforehand, agreeing that they know about the chance of a placebo, but that the medicine may have significant advantages if they receive the treatment. Placebo trials are necessary because they allow the doctors or the sponsors to see the real effects of the drug. If an individual is taking a drug that is supposed to cure depression, they may immediately start to feel better after taking the drug, because that is what the results and effects are supposed to be. The drug may not cure depression but the patients mind may trick it self into believing it has been cured and cause a change in emotions. The placebo will allow the doctors to see if the drug is actually working by noting that people who received the placebo are not feeling any effects at all or if the effects they are feeling are not brought about because of the drug. The 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. If a patient is coming to the doctor with a problem that could have been caused by the medication, then the doctor will may not know how to assist until after the trial is over.

 
Posted : 23/10/2018 2:07 pm
 dfn3
(@dfn3)
Posts: 78
Trusted Member
 

I agree! Placebo trials are important because we need a result that is not going to change. With this result we can then compare the other results to it to see if the other factor is useful. I do not see a problem with having a placebo trial I think they are very useful. I do not see anything wrong with it, I do not think it is unethical. It is needed to make sure we get accurate results with no bias. To have no bias they need to not know what they are given. I think they are necessary because they help show you the effects of the other factor since the placebo is basically the baseline.

 
Posted : 23/10/2018 5:08 pm
(@mb698)
Posts: 83
Trusted Member
 

Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a placebo treatment which is specifically designed to have no real effect. I think Placebo Controlled Trails (PCT) is important, necessary and its ethical because it compares with the standard treatment and it give opportunity to compare the results. Advantages of PCT includes, it allows estimation of the assay sensitivity and internal validation of the study. It allows better evaluation of clinical relevance. The sample size is small and lower study costs. The disadvantage includes, has higher risks from the non-treatment, more limited generalized ability of the results to the general population.

 
Posted : 24/10/2018 10:22 am
(@dsk35)
Posts: 38
Eminent Member
 

Placebos used in studies are useful because they act as a sort of control. As stated previously, the brain is very powerful and can allow you think something is happening, when it actually may not be. As long as the placebo stays in line with rules and regulations, it is ethical and is an important part of doing clinical studies. This allows the research conductors to see if the drug/therapy is legitimate and actually works.

 
Posted : 25/10/2018 3:42 pm
(@dkonara921)
Posts: 75
Trusted Member
 

One of the obvious advantages of a Placebo-Controlled Trial (PCT) is that it doesn't require a large sample size, which also implies lower costs. This can also help the clinician determine the relevance of the clinical trials to the objective. The trade-off to working with a small sample size is that if the results of the study are valid, the conclusions regarding the treatment cannot be generalized over large population as individuals of a large group are likely to be different from each other than those of a smaller group. In contrast, studies that rely on an active control have certain advantages such as: data regarding tolerability and efficacy of the treatment can be acquired and this type of study is more likely to be approved by an ethics commission. An active-controlled study entails higher costs because the sample size is relatively large. Efficacy differences between the treatments tend to be understated or overestimated when compiling and interpreting the collected data. Moreover, subjects tend to drop out of the study due to complications and adverse effects that can take place due to treatment. Overall, I think the placebo-controlled trial is the better type of study because it's not expensive and the sample size is small so the study is much easier to manage. The financial aspect of conducting the study is extremely important because you have to try to avoid wasting resources.

 
Posted : 25/10/2018 4:31 pm
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