Clinical Trials

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  • Created by: Wallis
  • Created on: 09-03-14 15:54
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  • Clinical Trials
    • The need for testing
      • It takes several years to develop a new drug before any kinds of testing.
      • A cancer drug may need 6 years in the lab before it reaches the stage of clinical testing.
        • During this time drugs may be tested on animals and on cell cultures
      • Clinical trials are needed to check the drug is effective.
      • It is necessary to find out any side effects that may be harmful, and what dose is effective.
        • Doses per drug may also vary between adults, children and elderly people.
    • Clinical trials
      • Phase 3 = comparison of the new treatment with the best currently available
        • The trials usually involve much larger numbers of people because new treatment might only be slightly better than existing treatment - so a large number will make the small difference noticable.
          • These trials involve thousands of patients in many different hospitals in different countries.
        • Phase 3 trials are often randomised. this means people are chosen at random to go into a group. (E.g. names out of a hat)
          • One group is given the new treatment while the other is given the existing treatment.
            • By choosing at random it ensures that on average the two groups will be as similar as possible the each  other.
      • Phase 2 = used to find out if the treatment works well enough to be tested in bigger phase 3 trials.
        • used to find out more what kinds of cancer the drug is effective against , and to find out more information about the best dose and any possible side effects.
          • These trials usually use more people than phase one. About 50 people may be involved . If these trials show the drug is as effective as existing treatments, or better, it moves into a phase 3 trial.
      • Phase 4 =  carried out after the drug  has been given a licence for doctors to prescribe it.
        • These trials are done to find out more possible side effects , and what long term benefits and problems are.
          • Also gives more information about how the drug works, as it is being used on larger numbers of people.
      • Phase 1 = the earliest trials in the life of a new drug or treatment.
        • Involves small numbers of people (-30) carried out to see the dose range, side effects, how the body copes,and whether it is effective. This takes a long time.
          • First few patients given a low dose, if it goes well the next few people will be given a higher dose - continues until the right dose is found
      • In many studies a placebo is given - this means they are given an injection or tablet that looks like the drug but isn't ('dummy')
        • This is done to make sure that it is the drug making the person improve.
          • Some people are biased and will say they feel better even if they have a tablet that is made of something like sugar.
        • The trial may not always use a placebo. E.g. if a phase 3 trial is carried out on people with cancer it is unethical to give one a drug and not the other, in this case one will use the new treatment and the other existing treatment.
      • Many studies are blind trials - this means that the person taking part does not know which treatment they are getting.
        • Studies may also use the double - blind trials - this means neither the scientists or patients know which treatment they are getting.
          • This is done by giving every patient a code number. A computer then randomly allocates the code numbers to treatment groups - list is kept secret until the end of the study.
            • This means the scientists are not biased and also prevents any psychological effects on the patients of knowing they have or have not been given the drug - such effects might affect the results.
    • The role of NICE
      • Stands for The National Institute for Health and Clinical Excellence
      • Evaluates the effectiveness of new drugs, and provides guidelines for the NHS.
        • In the UK, drugs can only be prescribed on the NHS using NICE guidelines - done so that public money is not wasted on prescribing ineffective drugs.
      • The NHS is paid for out of taxation and people don't want to pay more tax than necessary. So it is becoming increasingly difficult to fund the full cost of healthcare for everyone.
        • The NHS  should not have to pay for treating illnesses caused by a persons lifestyle - E.g. lung cancer in a person who smokes
        • We should all be prepared to pay more tax if this provides full healthcare for everyone.
        • We should all have to pay the cost of our own healthcare by buying medical insurance
        • People with breast cancer get better treatment that old people with Alzheimer's as they are sympathetic to their cause.
          • Other factors to consider as well is the difficulty in evaluating the benefits of extending a particular person's life by a few years when a complete cure is not possible.
      • Thousands of pounds are being spent every month on drugs just for one person.
  • Stands for The National Institute for Health and Clinical Excellence
  • Other factors to consider as well is the difficulty in evaluating the benefits of extending a particular person's life by a few years when a complete cure is not possible.

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