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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?

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 volunteersHealthy 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.

EventsFuture Events

  • A PSI Training Course on Improving Influence and Increasing Impact: Communication Skills for Industry Statisticians - Dates: 16 – 16 Sep, 2019

    This 1-day course will lead participants, in a non-threatening and encouraging atmosphere through steps to focus on improving the key skills of making impactful verbal and written communications.
  • PSI Webinar: Adaptive design: updated draft FDA guidance and its implications - Dates: 04 – 04 Jul, 2019

    In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
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