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Did you know…?

… that from initial discovery in the laboratory it takes on average 12 years to make a medicine available to patients?

Healthy
To make sure that a medicine is effective at fighting disease and safe to consume, pharmaceutical companies have to spend years rigorously testing it in clinical trials. Statisticians have a very important role to play in designing these trials and analysing the data collected to obtain the evidence needed to show the medicines work.

On this site you can explore how statisticians use their mathematical skills to improve patients’ quality of life and to save lives.

Introduction to Clinical Trials

Testing a medicine in clinical trials is a very long and expensive task, requiring pharmaceutical companies, doctors, hospitals, healthy volunteers, and real patients to work together. The video below, made by the European Federation of Pharmaceutical Industries and Associations (EFPIA), gives an insight into this journey.

Clinical Trial Quick Facts

  • Usually the first people to try out a new medicine are healthy volunteers. Healthy volunteers are used to find the maximum dose the body can tolerate, then this is used in trials on patients.
  • In a ‘gold standard’ clinical trial neither the patient nor the doctor knows whether the drug being administered is the new experimental one or the control treatment. This is called double blinding.
  • Clinical trials tend to be global, enrolling patients from many countries around the world.
  • It costs over $2.5 billion in research and development costs to bring a drug to market to be prescribed to patients.

Upcoming Events

Introduction To Industry Training Course 2020

The ITIT course will take 25 delegates new to the industry on a complete drug development experience from discovery to marketing. They will visit 6 companies to learn about 6 topics from experts in their field. The ITIT course will have 3 sessions in continental Europe and 3 sessions in the UK. The start of the 2020-2021 course will be delayed until face-to-face meetings with up to 30 people are permitted and companies are allowing travel again.

PSI Webinar: Patient preference studies

In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference.

PSI Vaccine SIG Webinar: Statistical Topics on COVID-19 Therapeutic and Vaccine Clinical Trials

We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'. Join us for this insightful and highly topical webinar.

Joint PSI, EFSPI & ASA BIOP Webinar: Estimands

PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on this topic to date.

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