Only ‘Smarties’ have the answer!

The Pharmaceutical Industry Research, development, production and marketing of new drugs.

Drug Development Process Aim: To gather enough evidence to convince government agencies, doctors and patients that a drug is safe and effective as a treatment for a particular disease. If an agency is convinced that a drug works they will grant a license to sell the drug in their country.

Drug Development Process Drug discovery: Scientists in laboratories discover the drug Formulation development: Make it into a tablet or injection Clinical trials: Doctors test the drug on volunteers or patients Marketing: Sell the drug to doctors Manufacturing: Make the drug on a large scale

How Statistics is used in Drug Development Designing Trials Writing instructions on how to conduct the trial (Protocol). Producing a questionnaire for scientists or doctors to record results on (CRF). Data Presentation Summarise the results of the trial. This could be using simple methods such as means, standard deviations and plots. Analysis and Interpretation Write up the results to explain if the drug worked and if it is safe to use. Convince doctors and government agencies to let us sell the drug.

The Skills of a Statistician Analysing data Problem solving Teamwork Presentation Decision making Managing projects Managing timelines Good quality work

Our Career Path Lyn Vicky 9 GCSE’s grades A-C 4 A’Levels Maths Further Maths History German Degree in Applied Statistics MSc Medical Statistics PAREXEL since 2001 Vicky 11 GCSE’s grades A-C 4 A’Levels Maths Economics Geography General Studies AS Level Sociology Degree in Mathematics Currently studying for a MSc in Statistics (whilst working !!) PAREXEL since 2007

Clinical Trail ‘Smarties’ Game Clinical trial that is designed to prove the drug reduces blood pressure Box of Smarties = Clinical Trial 1 Smartie = 1 patient Want to test a new drug hoping to lower blood pressure All patients in the trial have high blood pressure Group into 2’s

Open the Box! A green Smartie represents a successful patient = a patient with lowered blood pressure Any other colour represents a failure If you can show that 20% (a fifth) of your trial patients have significantly reduced blood pressure (succeeded) then your trial works!

Actions Count the number of patients in your trial Count the number of successful patients in your trial Count the percentage of successful patients: Add information to flip chart

Would you take this drug? Which trials were successful? How many trials were successful? How many were not successful? How convinced are you that this drug works? What if only 3/12 (25%) trials worked? What if 6/12 (50%) trials worked? What would you do?

What other factors might have affected your results?

What other factors might have affected your results? Who had the most patients? Who had the least? Are these results reliable? Medical factors affecting blood pressure? Age Gender Weight Other blood pressure medications Patient history of blood pressure

Conclusions Statisticians get involved with the design of the trial, analysis of results and interpretation of results. Maths doesn’t have to be boring !! Studying maths further leads to a variety of interesting careers.

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