1. Only ‘Smarties’ have the answer!

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

3. 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.

4. 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

5. 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.

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

7. 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

8. 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

9. 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!

10. 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

11. 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?

12. What other factors might have affected your results?

13. 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

14. 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.