Last week we learned how Dr. Goldberger used observations, inferences, hypothesis, and the scientific method to solve the problem of Pellegra. This week we conducted our own investigation to test a new headache medicine.
We simulated a clinical trial using two kinds of pink medicine; one was the "new medicine" and the other was a placebo or "fake medicine". Half the class received the placebo or control and the other half received the new medicine being tested. The results of this clinical trial revealed 3 possible outcomes; the headache is not cured, the headaches is cured, or the headache is cured, but you suffer side effects. Use your lab report and histograms to help answer the questions below.
Key words
- Clinical Trial- a test performed on volunteers, typically to test medicines, before the products are made available to the public.
- Control- a standard used for comparison that is not changed throughout the experiment.
- Placebo- a control that simulates a medicine, but doesn't have the active ingredient.
- Sample Size- the amount of people or things being tested. Larger sample sizes give more accurate data.
- Trade-Off- something given up for something gained.
Respond to both A and B by Tuesday 9/14
A) I would like for you to reflect or summarize what we've learned from activity 3, Testing Medicines. Please include all 5 of the above key words into your comments. Your response should touch on the key themes highlighted above and should be at least a paragraph in length.
B) Use this link to investigate types of clinical trials being conducted at the University of Cincinnati. http://www.uc.edu/ucresearch/clinicaltrials.html Go to General information and click on "types of trials". Summarize what happens at each of the 3 phases in your comments
19 comments:
Life Science Blog
Conner Kruse
Core C
9/9/10
In the investigation we tested a new headache medicine. One half of the class received a placebo or a fake medicine and another half got the medicine. The control in the clinical trial was that half got the medicine and half got the placebo. We had a sample size of 1 class or 28 students. We also had a trade-off in the trial it was if you got the placebo your headache would not be gone but if u got the medicine your headache would be gone.
A Phase 1 trial is usually the first time a new drug is given to people after tests are done in animals. A phase 2 trial is usually after the 1st trial and the drug is given to more people. A Phase 3 trial is after the 2nd phase in this type of trial, many people, sometimes thousands, are given the drug to see how well it works and if it causes problems when people take it for a long period of time.
Answer A: In activity 3 “ Testing Medicines “ we learned about a clinical trial. I also learned that there are many different kinds of sample sizes. I learned that you can control many different ways. We learned that different medicines can sometimes not always work right. And we learned that placebos don’t always work either.
Answer B: Phase 1 is usually the first time a new drug is given to people after tests are done in animals. This is done to find out if the drug is safe for people to take.
Phase 2 is when more people take the drug to study the side effects more carefully. This is done for researchers to try and find out if the drug has a good effect and tests it’s safety.
Phase 3 is when many people (thousands) are given the drug to see how well it works. This is done so that researchers can look for rare side effects when they take it for a long period of time.
Rachel Reif, Core C:
A: Our group and I had a new procedure the other day. We had to do a clinical trial on sample sized medicines. There were three different effects after we drank the sample sized medicines. They’re headache stayed the same, headache felt better, and headache felt better but had side effects. If the pink sample drink tasted the same as the yellow drink, then the headache didn’t change. If the pink one tasted better than the yellow one, the ache felt better. Next, if the pink one didn’t taste as good as the yellow, then your headache felt better but had side effects to it. The trade-offs in this experiment were that a few samples were the actual medicine. On the other side, the people who drank the sample size, nothing happened to them. That is what we did in Activity 3.
B: Before the scientists can give you the actual medicine, they have too test it on animals to see if the medicine is safe or not. Most of the time when the medicine is ready, only a few hundred people try it out to see if there are any effects to that medicine. If too many people take the medicine, there are going to be a few trade-offs. Also, if the medicine isn’t safe, the medicine will have this type of control to the person who is taking it. Some of the medicines have placebo, in which doesn’t do enough as it can do.
A) We learned that a clinical trial is not always bad, they help a lot of people. Clinical trials are helpful to a lot of people, you can leave at anytime. When you are in a Control a standard used for comparison that is never changed. They could give you a placebo it is a control that simulates a medicine, but doesn't have the active ingredient. You can Trade off being in a clinical trial for finding a cure. The bigger the sample size the better.
B) In phase 1 is the drug safe.
Phase 1 trial is usually the first time a new drug is given to people.. This type of trial is done to find out if the drug is safe for people to take.They try to find out the amount the people should have.People are often given different doses. They only have about 100 people in the trial.Phase 1 trials are short, usually less than 2 or 3 months long. Phase 1 trials usually study how safe a drug is.
Phase 2: Does it work?
If phase 1 works then phase 2. In a Phase 2 trial a lot of people are given the drug to see if it works and to study how it works. They see if it works well on different peoples bodies.. Phase 2 trials can last from a few months to a few years. In phase 2 things can still go wrong.
Phase 3: What if many people take it?
People take this drug for months or years but it has to be approved by the fda before it is approved.In phase 1 you probably won’t know a lot about the drug your taking but by stage 3 you will know.If you are in a control trial you know if the drug really works.
A) I would like for you to reflect or summarize what we've learned from activity 3, Testing Medicines. Please include all 5 of the above key words into your comments. Your response should touch on the key themes highlighted above and should be at least a paragraph in length.
In activity 3 (testing medicines) we learned that in a clinical trial there can be controls, a control is something that does not change. When we were doing our experiment Mr. Watts gave half the class placebo. In our experiment the trade-Off was that most people got well but had side effects from the medicine. The sample size can be any number of people or thing in the experiment
B) Use this link to investigate types of clinical trials being conducted at the University of Cincinnati. Go to General information and click on "types of trials". Summarize what happens at each of the 3 phases in your comments
In the first phase they test the product on an animal to see if it is safe for a human to test it. The people are often given different doses to see what the best amount to give for the medicine. In the 2 phase they have more people test the medicine and they study the side effects more closely. In phase 3 they have a lot of people try the medicine and see how long the side effects are and look for rare side effects.
Life Science Blog
Amy Hetzel
Core C
A.)In activity 3, Testing Medicines I have learned that in a clinical trial they take a sample size of people and nurses or doctors give the patients a control or placebo.(But only if the patient knows about it.) The trade-off of this activity is that most people got well but had side effects from the medicine.
B.)In phase 1 I summarized that how they test there drug trials on animals and by doing this they can se if the drug is safe enough for humans or not. In phase one it only takes about 2-3 months long and usually includes 100 people. In a phase 1 test they usually worry about how safe the drug is and what side effects people could have.
In phase 2 I summarized that they test there trials. They also study more closely on the side effects and safety. A phase 2 trial is used for longer months and sometimes years. They use more people and risks are much higher when testing.
In phase 3 I summarized that they get down to specifics. These tests are taken for an even longer period of time. Most of these drugs can make it through all three phases before seeing the reactions. Even though testing drugs can be deadly they get approved by what is called the FDA.
Allison B, Core c
Answer A:
In activity 3 (testing medicines), we learned that in clinical trials they use sample sizes. The sample sizes can be any number of people or thing. There are large and small sample sizes. We learned also in clinical trials there can sometimes be placebos. Placebos are simulated medicines. Controls are also used, a control is something that is not changed throughout the experiment. Clinical trials also consist of trade-offs, a trade-off is when you give up one thing for something you want more.
Answer B:
Phase 1 - In phase one the volunteers get a medicine that has only been tested in an animal body. This phase is the riskiest because they are the first humans to try it. The volunteers are given different doses to conclude on one safe dose of the medicine. In phase one the trials are short and little people do the trial. The purpose of phase one is to see how the drug affects the human body and to study how safe the drug is.
Phase 2 - In phase two volunteers take the drug to see if there are possible side effects and to see if the drug works. Phase two is only conducted if phase one shows that the drug is safe. In phase two the trials can have hundreds of people and last from a few moths or a few years. There are still possible risks and benefits from phase two.
Phase 3 - In phase three there can be thousands of participants and trials from a few months to a few years. In this phase they look for effectiveness and rare side effects. In this phase they also check backgrounds and genes to see if they are effecting the use of the drug. In some phase three trials there are different variables according to gender, race and age.
A:
In activity 3 we performed/acted out a clinical trial using a pink drink to represent the medicine and a yellow one to represent our headaches. In our clinical there were two controls half of us received a placebo and the other half of us received the actual medicine. In the clinical trial our sample size was small and was a group of about 28 students or 1 class. At the end when we found out who had the placebos and who did not we discovered that in partaking of clinical trials there are trade-offs in that you could be taking a placebo thinking that it is really medicine and expecting relief from your head ache and find none. Or in that you could be taking the real medicine and gain relief but also gain unwanted and expected side affects. Also in that you could be taking the real medicine and get relief. Or lastly you could take the real medicine and get no relief.
B:
In a phase one trial the scientist or physicians do testing by giving the drug to first animals and then people to make sure the drug is safe to release into the public.
In a phase two trial the physicians and scientist give the drug to up to hundreds of people to closely study and examine the side affects of the drug, that is if there are any.
In a phase three trial they give the drug to up to thousands of people to discover how well the drug works, what happens when it is taken for long periods time, and what the rare side affects might be.
Core:C
A: In Activity 3, testing medicines I learned that when doing a clinical trial the doctors or nurses will take a sample size of people. The doctors will also give some of the patients a control and the others the placebo. During the activity, the trade-off was that they got better but they had some side effects from taking taking the medicine.
B: In the Phase 1 trial, it is usually the first time the new drug is given to people after it has already been tested on animals. All the people in Phase 1 trial are getting the drug that is being studied but most of the time during Phase 1 they are trying figure out the best amount of the drug to take. Phase 1 is riskier than Phase 2 or 3 trials. Phase 1 trials are short and usually last about 2 or 3 months.
In a Phase 2 trial more people given the type of drug to see if it works and they watch the side effects more carefully. In this trial the researchers try to figure out if the drug has good side effects. They say that Phase 2still has risks and can last from a few months or a couple of years.
In a Phase 3 trial many or maybe thousands of people are given the drug to see how well it works and see if it causes problems if they take it for a long time. Most drugs will go through all three phases before they are approved. But they said that if the drug is for a disease that is life threatening then the drug is usually approved after Phase 2.
A) What I have learned from this project is what a clinical trial is. We had to be in a fake clinical trial and group 3,5 and 7 were placebos. I was in group 7. I got a placebo, which means I didn’t get the real cure for my headache. I had a controlled test through the experiment. I had a placebo the whole time. The sample size was a bout 18-22 people, so I guess that was a pretty good sample size. The trade-off was I got to help make a medicine that will help a lot of people. The bad part was I got a placebo for my test, which didn’t help my headache.
B) In this first phases I found out that the first phase is the most risky. That is because they don’t know if it would work on humans. They have only tested it on animals. The first stage is always shorter than the second and the third stages. This stage is all about safety and seeing all the things that need to be fixed. In the second stage it has a lot more people than the first stage. It could take one month to one year. So it all depends how the medicine is coming along if it is doing good than it will take a short amount of time. If it is long it will take a longer amount of time. The last stage, stage three. In this stage there is about one thousand people in that group. They all are using that one medicine for that one sickness. There are rare people getting sick from taking the medicine.
A) What I have learned from this project is what a clinical trial is. We had to be in a fake clinical trial and group 3,5 and 7 were placebos. I was in group 7. I got a placebo, which means I didn’t get the real cure for my headache. I had a controlled test through the experiment. I had a placebo the whole time. The sample size was a bout 18-22 people, so I guess that was a pretty good sample size. The trade-off was I got to help make a medicine that will help a lot of people. The bad part was I got a placebo for my test, which didn’t help my headache.
B) In this first phases I found out that the first phase is the most risky. That is because they don’t know if it would work on humans. They have only tested it on animals. The first stage is always shorter than the second and the third stages. This stage is all about safety and seeing all the things that need to be fixed. In the second stage it has a lot more people than the first stage. It could take one month to one year. So it all depends how the medicine is coming along if it is doing good than it will take a short amount of time. If it is long it will take a longer amount of time. The last stage, stage three. In this stage there is about one thousand people in that group. They all are using that one medicine for that one sickness. There are rare people getting sick from taking the medicine.
Nick willis said:
A. In the experiment we learned how a clinical trial gives out a placebo to some of the group. We also learned that control is like how the sample size never changes, and how a trade off can be like getting rid of your head ach but ending up with a stomach ach.
B. phase 1. They give the pill to animals to test it on them and if it seems safe they give it to people in a clincal trial.
B. phase 2. They observe the side effects from a clinical trial and test if it is safe or not.
B. phase 3. They study people who have taken it over a long peorid of time and they check for rare side effects and if safe the F.D.A it is realeased into the public.
A. What did I learn in Testing Medicines? I learned that scientists do Clinical trials on sample sizes of people who are willing to take medicine. Part of the sample size takes placebos or a control that simulates a medicine, but doesn't have the active ingredient. The other half of the sample size takes the control or a standard used for comparison that is not changed throughout the experiment. A trade-off for some of those people could be that they have a side affect and might get hurt.
B. Answer B: Phase 1 is usually the first time a new drug is given to people after tests are done in animals. This is done to find out if the drug is safe for people to take. Phase 2 is when more people take the drug to study the side effects more carefully. This is done for researchers to try and find out if the drug has a good effect and tests it’s safety. Phase 3 is when many people (thousands) are given the drug to see how well it works. This is done so that researchers can look for rare side effects when they take it for a long period of time.
Noah Griffith
A)
The experiment was a Clinical Trial. The class had a control while doing the experiment which was the amount of medicine givin. Half of the class had a Placebo which was the fake medicine while the other half had the real medicine. The sample size of the experiment was the students that tested the either the Placebo or the real medicine. The Trade-off in this experiment was either the headache felt better, the headache felt the same, or it felt the same but also had side effects.
B)
The first experiment they did was tested the product on an animal to see if anything happened to it. In the second experiment they had people test the medicine in different doses to see if that had any side effects. The third experiment was to see if the amount of people that took the medicine got any rare side effects from taking the medicine. If they did the scientists recorded how long it lasted and how seveer the side effect was.
A)
In activity 3 we did a clinical trial. In this expermint the sample size was core 3 in Mr. Watt's room. Half the class got a fake medicine otherwise known as the placebo, and the other class got the real medicine. The control was the placebo, which we compared the real medicine too. In the end if you took the real medicine some people had a trade off such as they would get rid of the head ache but their hair would fall out.
B)
1) Phase one is usually when the drug is being tested for the first time, they test it on animals first to see the effect it has.
2)In trial 2 they start to give people the medicine to test it out.
3) in phrase 3 a lot of people some times up to a thousand, are given the medicine to see how it effects people over a long period of time.
Part A:
In Activity 5, we learned about testing medicines. In most tests, a placebo, or fake medicine is used as a control to compare the medicine to. In a clinical trial, it is important to have a larger sample size so you have more data to compare when doing research. In many clinical trials, there are trade-offs, or choosing one thing but giving up another.
Part B:
In a clinical trial, the first phase of the trial is to test whether or not the drug they are testing is safe for people to take. Phase one uses a small sample size, and not much is known about the drug, making Phase 1 risky.
Phase 2 tests whether or not the drug is effective when taken, and they also look at possible side effects of using the drug. In a Phase 2 trial, there are a few hundred people.
Phase 3 tests whether or not there are any side effects after the drug has been taken for a long time. There are thousands of people in a Phase 3 trial. A drug will come to a Phase 3 trial after it is cleared through a Phase 2 trial, and after it is approved by the FDA. However, in life threatening illnesses, many drugs are shipped after Phase 2, then approved by the FDA later.
Joe Anderson Core C
in this clinical trial we tested headache medicine's.Then some students received the placebo and the other got the real medicine.And the control was the real medicine and was used to be compared.And the trade off was that some of the students got rid of there headache and the other didn't.
phrase one is the medicine safe?
The medicine is usualy safe cause the medicine is tested on animals to see if its ready to be tested on humans.
Phase 2 does it work?
This phase it to see if the side affects are more harmfull the the human body so they study it more carefully.
phase 3 what if many people take it?
Many if even thousands will take this phase trial to see how many people will get these side affects from the medicine and doctors look too see for rare symptoms as well.
Sarah Keethler
Core C
10-23-10
A)
During Activity 3 "Testing Medicines" we designed a clinical trial to test a new headache medicine. We did a test and found the controls and the sample size. First Mr. Watts gave half the class a placebo and the other half the new headach medicine(without telling whose who). We discussed the Trade- offs of haveing the new medicine and we made clear observations. In the end we found out that the new medicine did not work based on our observations . The Trade-off in the clinical trial is if you take the medicine then you will get a stomach ache.
B)
1) For Phase 1 this is a trial where the medicine is tested on animals first to see if it is safe for humans to use, the amount of medicine to take, and sometimes the effectiveness on the body. In this trial a group of people, each person gets a different amount of medicine. This group has a small sample size(less than 100 people) which makes it at greater risk.
2) For Phase 2 this is a trial to see if the medicine works. This Phase has a faily good sample size of a couple hundred people and can last as long as a few monthes to a few years. Although there can be some Trade- offs.
3) Phase 3 is started by the results of Phase 2. Phase 3 is to see how well the medicine works and to see if it causes problems to people who take it for a long period of time.This Phase has a great sample size with many people sometimes thousands! In a trial ( Phase 4) the medicine is tested to see if gender, race, or age has an effect.
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