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Title: Clinical trials 28 th February 2014

Title: Clinical trials 28 th February 2014. Learning question : What are clinical trials and why do we need them?. Homework: Your test is next Wednesday – study!. http://news.bbc.co.uk/1/hi/england/london/4807042.stm. Aims from specification document.

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Title: Clinical trials 28 th February 2014

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  1. Title: Clinical trials28th February 2014 Learning question: What are clinical trials and why do we need them? Homework: Your test is next Wednesday – study! http://news.bbc.co.uk/1/hi/england/london/4807042.stm

  2. Aims from specification document (f) describe how clinical trials may be used to establish the value of a cancer treatment, with reference to the need for ‘blind’ or ‘double blind’ trials, randomisation and the use of placebos (g) discuss the social, ethical and economic consequences of both the development and use of cancer treatments.

  3. The need for testing • Clinical trials are required to check that the drug treatment is actually effective. • Any side effects need to be explored, as does the effectiveness of different doses. • 1/1000 drugs that are created actually make it to the clinical trial stage. • Before human testing, cell culture and animal testing is carried out.

  4. Clinical Trials

  5. Phase 1 • Earliest trial in life of new drug • Fewer than 30 people used to explore dose range, side effects and how the body copes with the drug. Also if the drug is effective! low dose administered positive result found increased dose in other patients continues until correct dose is established • Phase 1 patients in cancer trials usually have advanced cancer and had all other available treatments. • Some may benefit, most will not.

  6. Phase 2 • Phase 2 trials of cancer drugs used to find out what cancer the drug is most effective against • Also to find out more information about best dose and side effects • About 50 people involved in this trial (more than phase 1) • Success means that the trial can move into phase 3

  7. Phase 3 • Involves much larger numbers than previous trials - new treatment might only be marginally better than existing drugs, so larger sample size is required to establish a difference • Trials may involve thousands of patients in different hospitals worldwide.

  8. Phase 4 • Carried out after drug has been given licence for doctors to prescribe it • These trials are done to find out more about: • possible side effects • Long term benefits/problems • More information about how the drug works (again a larger population is being used)

  9. Randomised testing and placebos • Phase 3 trails (large scale, conducted in hospitals) are often randomised, this means that people are chosen at random to go into a group. • Dividing people into groups randomly ensures that the groups will be similar to each other • One group is given new drug, other group given older drug

  10. Randomised testing and placebos • Placebos are often given to patients during clinical trials • Placebos are things that look like the real drug, but does not contain the drug being tested – “dummy” treatment • Placebos are given to stop any bias towards the drug, or to make sure that it is the drug that is really making the improvement and not a psychological effect. http://www.youtube.com/watch?v=vMefuqseEeY

  11. Randomised testing and placebos • Drug trials do not always use placebos – in cases of cancer patients, this would not be ethical • Instead a new drug is used an a currently available one is used that doctors know works.

  12. Blind and double blind • Blind trials – person taking part does not know which treatment they are going to get – new drug or placebo • Double blind trials – neither the scientists or participants know who is receiving the new drug or placebo • Computers randomly allocate code numbers to patients and the scientist administers the drug/placebo according to the code • Codes are kept a secret until the end of the study – prevents psychological effects on patients and scientists. Such effects could impact on the results of the trial.

  13. The role of NICE • The National Institute of Clinical Excellence (NICE) evaluates the effectiveness of new drugs and provides guidelines for the NHS • Only NICE approved drugs can be prescribed on the NHS to ensure public money is not wasted on ineffective drugs

  14. Funding the NHS • Providing free healthcare is expensive. • Drug trials can cost thousands of pounds per person treated, so for the NHS to be maintained, either the public will have to pay higher rates of taxes, or it reduces the services it provides. • Read the bullet points on page 77 of your textbook. Do you agree or disagree with the points raised? • Whatever your opinion, back it up with an explanation!

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