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Unit 1 - Clinical Trial

Drugs affect our body chemistry and are used in a variety of different ways to help healing - painkillers, antibiotics, vaccines and so on. When new drugs are developed they need to be tested prior to medical use in humans, and seeing how this is done is one part of GCSE Biology. Clinical trials involve the large scale testing of drugs on volunteers and provide essential information about their safety and efficacy (how effectively they work). During clinical trials, the volunteers are monitored closely and any side effects can be discovered too.

Clinical trials need to be carried out under carefully controlled conditions in order not to come to the wrong conclusions and jeopardise patients' safety. In a blind trial, the best method of testing, the patients do not know whether they are being given the drug or a placebo. A placebo is something that looks like the drug but actually contains no active ingredients. In some trials, neither the doctors nor the patients know who has taken what until the trial is over. This is a very good way of filtering out any errors.

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In the 1950s, a drug called thalidomide was being developed and testing was done on people with respiratory diseases. After some clinical trials it was also found to be an anti-emetic, in other words, it prevented vomiting. During pregnancy, many women suffering from morning sickness bought the drug. It had never been tested on pregnant women and shortly after it went on sale, some of these women gave birth to badly deformed babies, half of whom died. Following this tragedy, regulations about clinical trials before new drugs could be sold were changed, in order to avoid something like this occuring in the future. Thalidomide is still being used but as an anti-cancer and anti-leprosy drug, where its safety has been thoroughly ensured.

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  1. Before clinical trials, which of the following are new drugs not tested on for toxicity?
    It is a legal requirement for drugs to be tested on animals for toxicity
  2. Statins are drugs which lower the blood concentration of what?
    High cholesterol is linked to heart disease. Eating a diet that is not balanced can increase the risk of suffering from high cholesterol levels. Some scientists have found that exercise can help to balance cholesterol levels in the blood but more research is needed
  3. Which of the following is a reason that patients must stop taking a prescribed drug?
    With current laws, it is unlikely that a drug would ever reach the market unless it is shown to be effective
  4. New drugs are all tested for efficacy, toxicity, dosage and what else?
    New drugs are first tested for safety using computer models and then on non-human animals. Volunteers in clinical trials are carefully monitored just in case it proves to be unsafe for humans despite the previous research
  5. In a double blind trial, who is allowed to know if the patient has taken the drug?
    If the patient and doctors know they are being treated with the drug, this may influence their perception of the effects of the drug
  6. The drug thalidomide was banned because it caused which side effect?
    Other effects included deformed eyes, hearts, alimentary and urinary tracts, blindness and deafness. It was withdrawn from sale but not until at least 10,000 people around the world had been affected
  7. A sample of what is taken when athletes are routinely drug tested?
    Drug testing may be carried out on blood or urine samples
  8. What does a placebo consist of?
    A placebo must resemble the drug being tested so that clinical trial volunteers don't guess that they are not taking the real thing
  9. During a clinical trial, variables need to be controlled including age, state of health and what else?
    It is possible that a drug could affect women differently to men
  10. Which word describes the effectiveness of a drug?
    Clinical trials are also used to determine the minimum dose needed for the drug to be effective

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