Objectives • outline the process of testing new drugs for safety and effectiveness Drug Testing Drugs must be tested • To check that they work • To check that they are not toxic • To test for side effects It takes years to develop a new drug • Tests on animals are • Tests on humans are called laboratory called clinical trials tests. • Drugs tested in the lab on cells are called • In vitro tests • Trials using animals or humans are called • In vivo tests 1. Search through natural sources to find a chemical. Look at computer models. Do In vitro tests on human cells 2. Animal tests 3. Clinical trials Drug Testing. Put the following in the correct order. f. Tests on human volunteers. e. Computer modelling. a. Tests on animals. d. Tests on a few people with the illness. c. Find a suitable chemical. Look at earlier treatments. Look in plants. b. Tests on human tissue samples.. The correct order is ……… c. Find a suitable chemical. Look at earlier treatments. Look in plants. e. Computer modelling. b. Tests on human tissue samples. a. Tests on animals. f. Tests on human volunteers. d. Tests on a few people with the illness. WHY IS EACH STAGE NECESSARY? WHY EACH STAGE IS NECESSARY c. Find a suitable chemical.. e. Computer modelling. Checks that the molecules are the correct shape. b. Tests on human tissue samples. Checks that the new drug is not toxic. a. Tests on animals. Check for side effects. Does the drug work in a whole animal f. Tests on a few human volunteers. Check for side effects. d. Tests on a few people with the illness. Does the drug work? Patents • If animal tests go well, then the developers will apply for a patent • This means no other company can sell the drug for 20 years • However, because clinical trials take so long, the company only gets around 10 years when they are the only ones selling the drug Task • Use your text books to complete the table STAGE TESTING TO FIND OUT ONE Drug tested on human 1. How safe the drug cells grown in the lab is for human cells (In vitro tests) 2. How well it works against the disease TWO THREE Clinical trials • People who take part will be put randomly into one of two groups. Random groups are important so the results are reliable • One group will be given the new drug, another group will not. This is the control group • Results from both groups are compared Clinical Trials • Double blind trial: • The patient and the doctor do not know if they were getting the new drug or not • Blind trial: • The doctor knows but the patient doesn’t. This may be so the doctor can look for a certain side effect • Open trial: • Both the patient and the doctor know • A random double blind trial is the best type Placebo • In most clinical trials the control group are given the treatment currently used • If there isn’t any current treatment a placebo is used. It looks like the real treatment but has no drug in it • Using a placebo in clinical trials is very rare Ethical issues • It may seem unfair that the control group miss out if they take a placebo but proper testing is needed • If the trial shows the risks are too great it will be stopped • If the trial shows the drug has benefits it will immediately be offered to the control group No control group • Occasionally a new drug is given to all the patients • This is where there is no current treatment and the patients are so ill they will not recover by themselves • It would be wrong not to offer the hope of a new drug to all those patients Questions • Explain why drug trials must be random • Explain the differences between blind and double blind trials • Describe a situation in which it would be wrong to use placebos in a trial • Drug testing in the United Kingdom is thorough and effective. • However, occasionally things go wrong. • Do you know anything about a drug called thalidomide? • Do you know anything about the TGN1412 drug trials of 2006?
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