Treatment vs. Clinical Research

Some definitions for this case:

Clinical research is the science of effective medical care. Clinical research does experiments that compare a standard drug with a new, unproven drug. The scientist observes each patient group over time to see which drug works better. Sometimes, the patients in the study (research subjects) can’t tell the difference between ordinary medical treatment and being in the research study. This happens even though all the research subjects are told at the beginning that they are joining a research study.

This misunderstanding is called the “therapeutic misconception”- when research subjects think they are getting standard treatment instead of research. In other words, the therapeutic misconception is when sick people participating in a research study believe they are getting standard medical treatment.

A clinical trial is a comparison of a standard drug, against a new, unproven, drug ( the study drug). How can the researcher be sure that patients getting each drug (standard drug and the study drug) are equally sick? One way is to give all the research subjects the study drug, one at a time. For the first part of the study, half of the subjects are given the standard medicine. The other half get the study drug. In the second half of the study, the drugs are switched around. The scientists then observe which medicine works better over the duration of the study. This kind of study is called a “crossover” study, because the each drug is “crossed over” to different subjects over the study period. The study subjects don’t know which drug they get. Not only that, but the study doctors don’t know which drug the subjects get. This is called a “double-blind” study. “Blind” because the person doesn’t know which drug is given. “Double” because the subjects AND the doctors don’t know which drug is given. The double-blind method prevents bias from interfering with the study results. Bias is when the doctor or subject wants one of the drugs to work better.

The Case:

You are a clinical researcher comparing a standard skin cream (Plain P) with a new skin cream, Super X. You want to find out if Super X is better than Plain P for the treatment of psoriasis (a skin disease). You use a crossover, double-blind research design. The subjects are split into two groups. Group A gets Plain P for the first half of the study. Group B gets Super X for the first part of the study. For the second part of the study, Group A gets Super X, and Group B gets Plain P. One researcher does tests that measure the improvements, but she doesn’t treat the subjects, just measure their improvements. The other researcher gives out the creams and follows the research subjects.

Before you start the study, you spend an hour going over the study procedure with each volunteer subject. You have all the subjects sign a consent form that tells all the details of the study. All the subjects say they understand you when you go over the study plan. You emphasize that this is a research experiment and none of the participants will be able to stay on Super X after the study is over. This is because Super X is not yet approved by the government for doctors to prescribe. You have 20 study subjects in the study. All study subjects get both drugs, but at different times in the study.

At the end of the study, many of the study subjects have improved. Fourteen of your 20 subjects ask why they are being taken off Super X. These fourteen subjects thought they were on Super X the whole time.

Questions:

1. Do you think the fourteen subjects had a “therapeutic misconception?”

2. What would you say to them about getting Super X?

3.  Do you think the results of the study are invalid?

4. Do you think the study results should be thrown out because so many of the subjects didn’t understand the research? Why? Why not?

Student Responses

11.06.09
1. No, I believe they did not have a "therapeutic misconception" because they were told this was a research and they will be receiving both drugs. They also signed a consent saying they understood the research and understood they can not stay on Super X after the experiment.
2. Super X has not been approved by the government and maybe will never get approved even though it showed a sign of helping. Plain P works just as well and they should continue using it.
3. Yes and No. Yes because they both showed a sign of improvement but since they were given the two drugs and different times, maybe the other one started kicking in and working better than the other one, but they might not have known this because they switched both of them.
4. No the study results should not be thrown out because the subjects clearly understood what was going on and what they were being researched for. If they did not understand, they should not have signed a consent stating they understood.

B.R.- Mansfield Summit High School

11.05.09
1. Although the details of the experiment were given to them, and it was explained that it was a research study, the fourteen subjects misunderstood and rather believed that the medication was standard treatment. So, it wasn’t therapeutic misconception because they signed a consent form that stated all the details of the study, and they were fully aware of being research participants. In therapeutic misconception, the sick patient isn’t entitled to knowing that they are research subjects; in this experiment, the subjects had certain details provided to them, in writing and verbally.
2. I would warn the research participants that Super X is still an unapproved medication from the government and that taking Super X would be at their own risk. I would, also, emphasize that Super X is not a standard treatment and rather an experimental drug that they all have agreed to take and were given certain details about. Also, if studies prove to be successful, the drug, Super X, could possibly be available in the future.
3. The studies are valid because it did follow standard procedures and prevented the placebo effect by allowing for a double-blind experiment. In the placebo effect, research subjects are told that the medication can improve their condition, and with this information, the subjects often improve on what they were told. This was avoided by not telling the subjects what drugs were used, so they couldn’t develop a bias towards them. However, by confining the experiment to a small group, the results tended to be more inaccurate and didn’t provide sufficient data to successfully support any of the experimental drugs’ effectiveness.
4. The results shouldn’t be thrown out for that reason. Physical results especially through a purposefully blind experiment are more solid data than data taken from an experiment where people are aware and be given the chance to be biased towards a certain drug. Besides, these subjects realized that they were undergoing a research study and the certain risks, so the subjects did have to understand most aspects of the research to have signed the form willingly. However, this data should only be used as initial data. More studies should be conducted with more people, so that an overall conclusion can be made about the drugs’ effectiveness.

C.A.X. - Mansfield Summit High School

11.05.09
1. No, The subjects knew ahead of time that they were going to be in a research study. The researcher went over the study for a hour. They should have fully understood the study before signing the consent.2. I would tell the subjects that Super X is still going through testing and it has not yet been approved. I would also tell them that no one can leave with Super X because it is still going through testing.
3.No, I believe that the studies were valid. The subjects knew what they were getting into. Just because some were confused doesn't mean that they study was invalid.
4.No, the study should not be thrown out. Just because the subjects thought that they were on a different medication the entire time doesn't meant that the study was incorrect. The study was over the physical changes of the body. The study was not over if the subjects knew if they were having the creams changed on them, that was their own problem.

K.R.-Mansfield Summit High School

11.05.09
1. These fourteen research subjects did not have a 'therapeutic misconception'. They knew all along that they were participating in a research study, as it clearly stated in the text that you went over the study plan. They just thought that they were using the Super X cream.
2. Well, since it hasn't been approved by the government yet for the doctors to prescribe to patients yet, I would have to tell them that they cannot have the cream just yet. It has to go through some further tests, and actually get approved by the government.
3. I think that the results are invalid. I think that because they didn't find out which drug did the better job at treating Psoriasis.
4. Even though the results were invalid, they should still be kept. You should never throw out good data. And besides, there were some improvements in some people's cases.

A.P. - Mansfield Summit High School

10.26.09
1. Yes the 14 participants thought they were in Super X the whole time throughout the study meaning having a therapeutic misconception.
2. I would have shown the consent form and say that the rules were that participants couldn’t stay with Super X because the medicine has not been approved by the government for doctor’s use.
3. No, I believe the research was fair and the studies were correct even if people thought they were in a certain type of medication.
4. No, the research shouldn’t be thrown out because even if people didn’t understand the research it didn’t matter because they still signed the consent form, and the study was focusing on the physical changes and not on people’s knowledge of the research.

J.M. - South Texas High School for Health Professions

10.25.09
1. No, these subjects simply believe that they were on Super X the entire time. Never once was it mentioned that they thought they were being given treatment, so they knew that they were just being used as research subjects.
2. I would say that Super X is still undergoing testing and that it has not been approved by the government at the time.
3. Not necessarily. Results were produced and those results seem to hold some truth to them. However, a group of just twenty people is not enough for accurate test results. More tests need to be held that have a large number of participants.
4. No. Just because the test subjects did not fully understand exactly what was going on, it does not mean that they became biased towards one of the products.

Z.B.- South Texas High School for Health Professions

10.23.09
1. No, because they spent an hour going over the study procedure and they also signed a consent form saying that they understood the research.
2. That  it may clear your skin disease, but it’s not yet approved.
3. Yes, because they may not have used the cream correctly.
4. Yes, because you would not want all subjects to understand the research so you can have accurate results.

A.R.

10.20.09
1. No, the fourteen subjects did not have a therapeutic misconception, because they all signed a form of consent stating that they were going to participate in a research project that was testing a new drug, Super X, which isn't the standard treatment.
2. I would first tell them that they all were not on Super X at the same time so they really have no idea which drug works best for them.
3. The results in the study aren't invalid but are not precise and useless. There should have been two results recording one after the first half and the other from the second half, then it would be clear on which pill worked and which didn't.
4. Regardless if the subjects understood the study results or not, the results should be thrown out because they are misleading and do not fully inform the subjects or outside people clear results that tell you which drug works best.

D.H. - Haltom High School

10.18.09
1. No, I do not think that the subjects had a "therapeutic misconception". They were all told from the beginning that they were participating in a research study. They signed consent forms that told them the study plan. Because it was a research project, they should have understood that they would not be getting standard treatment.
2. That they were told from the beginning that they wouldn't be able to stay on Super X because it had not been approved for doctors to prescribe.
3. No, I believe that they are valid, but not as accurate as they could be. All of the subjects used the drugs in the correct way, despite not knowing what they were using. However, a twenty person study is not very large, and the results they got may not be completely accurate because of that.
4. No, because the results are valid despite the fact that the subjects were unaware of what was going on. They should have understood, because they signed forms saying that they did at the beginning, but the fact that they did not understand does not change the results.

R.B. - Haltom High School

10.18.09
1. I think that the subject had a therapeutic misconception because the subjects knew that they were going to be part of a research project.
2. I would tell them that they were part of a research project like they were told in the beginning.
3. I do not think the results were invalid, because the project worked on the subjects.
4. I don't think they should be thrown out because the research was effective on the subjects and the subjects were told that they were part of a research project only.

Y.T. - Haltom High School

10.17.09
1. No, I do not think they had a "therapeutic misconception" because of the fact that they were told beforehand all the procedures and details of the study. They even signed a consent form telling them all about it.
2. I would tell them that it'll might take a while for the government to approve the cream depending on the result of the study. If it does get approved, then they can purchase it if they want.
3. Yes, because 14 people thought that they were still on Super X. If they couldn't tell the differences between the two creams, then Super X is no different than Plain P.
4. No. They should have already known about the research because they signed the consent. If they didn't understand it, then why sign it? Some people found improvements while others didn't.

D.N.- Haltom High School

10.16.09
1. Yes, because seventy percent occupants seemed to be unaware of the study taking place.
2. Obviously they could not distinguish the differences in Plain P and Super X. There was no advancement made.
3. No, through the use of therapeutic misconception, the subjects did not impose a biased opinion. I believe the results are valid.
4.No, although they may not have understood the concept of the research, the physical results still remain the focus of this study.

S.V.- Haltom High School

10.16.09
1.Yes, I think the fourteen subjects had a " therapeutic misconception", because they were still wondering why they were taken off "Super X".
2.I would tell the subjects that I could not get them "Super X", because it has not been approved by the government.
3.The results were not invalid but they also were not valid at the same time. More testing should help show which cream might be more suitable for the subjects.
4.I think the study results should be thrown out because they should have done a longer test run instead of half of a day.

JDC- Haltom High School

10.15.09
1. I think the 14 patients had a "therapeutic misconception" because the whole test they thought they were on the test drug. That thought gave them a false hope, which has been proven to improve a patients condition.
2. I would tell the patients who had received "Super X" afterward that hopefully since the drug test was successful (for the doctor's results) it might be able to be prescribed and available soon.
3. I think that the results of the study are invalid because an unintended placebo was used on 14 of the patients.
4. I think the research should be thrown out;an unintended placebo was used, which can cause the test results to become untrue.

H.F. - Coppell New Tech High (CNTHS)

10.15.09
1. In a way, they are but they aren't. They are aware of what's going on and that they are part of an experiment for research because it clearly stated that you went over it with them for an hour about what they were doing there and the purpose of the experiment. But they also wanted to know why they were taken off the Super X cream, and that left them unaware of the research they were helping with. I'd go with no;it wasn't a therapeutic misunderstanding because they did know what was going on.
2. I would say that Super X was a little biased because it worked just as well maybe even not as well as the Plain P product and it was biased just because it was a new cream and had Super X in its name doesn't make it much better than the first cream.
3. A little, everyone's opinion on Super X was biased because they thought it was some new amazing skin cream that would cure the skin disease when actually Plain P worked better. Also, Super X wasn't approved by governments yet so it might not be ok.
4.Yes, I think people should redo this experiment because not a lot of people understood why they were taken off of Super X and thought they were on Super X instead of Plain P, saying that it helped them more than the original skin cream did. They didn't really understand the whole purpose of the presentation or the experiment and didn't help much with research.

A.B. - Coppell New Tech High (CNTHS)

10.15.09
1.Yes, they didn't know their creams changed.
2. They shouldn't get it till gets approved.
3. Yes, they are valid. It shows that Plain B is better than Super X.
4. No, they should keep them to compare with the next set of results.

D.S. - Haltom High School

10.12.09
1. I think that they did not have a therapeutic misconception. Because they were told that they will be getting both and they did say that they understood that they will be getting both.
2. I would say remember at the beginning that the government has to approve "Super X" to distribute it.
3. I think the results are invalid because they got both Plain P and Super X and they don't know which did the job better.
4. No, I think that they should do another test without crossing over because the point of the test was to see if Super X was better/ faster.

J. B. - Haltom High School

10.12.09
1. No, they did not have therapeutic misconception because they knew they were on Super X which is not a standard drug.
2.I would tell them not to use Super X because it is not approved by the government, and obviously if they thought they were on Super X the whole time, then it isn't any better than Plain P.
3.No the results are not invalid because, in this area, the results are not any different than Plain P. More testing should be done to find out in what circumstances Super X would be different than Plain P.
4.The study results should not be thrown out because the subjects said they understood what was going on, and regardless, the subject's knowledge does not affect the experimental results.

C.C.- Haltom High School

Interactive Ethics/Posted Comments: 10/01/09-10/02/09