Only Smarties have the answer The Pharmaceutical Industry

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 • 11 GCSE’s grades A-C • 4 A’Levels – Maths – Further Maths – Economics – History – Geography – German – General Studies • Degree in Applied Statistics • AS Level Sociology • MSc Medical Statistics • Degree in Mathematics • PAREXEL since 2001 • 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

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 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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