Clinical Trial Design is a Key Statistical Area

Clinical Trial Design

Developing the most appropriate clinical trial design is vital to ensure that your study leads to unbiased conclusions and is designed in accordance with ethical guidelines. In particular, from both commercial and ethical viewpoints the trial design needs to minimise the chance of the ending up with inconclusive results. WILKINSON ASSOCIATES provides expert and innovative advice on a wide range of aspects of clinical trial designs, including the important area of sample size calculations. We often find that we can make major improvements to study designs, at minimal costs. We are happy to provide some initial ideas and advice free of charge at the start of a project.

Planning a Clinical Trial

WILKINSON ASSOCIATES can offer advice to those planning a clinical trial, providing guidance on:

  • Methological issues, such as the study design, optimal efficacy and safety variables, and the use of control groups
  • Statistical issues, such as the determination of sample sizes, the use of appropriate statistical tests, the adjustment for confounding variables, and the role of stratification
  • Possible options for stopping the study early, and what actions to take in the vent of disappointing recruitment rates.
  • We can also advise on appropriate Interactive Voice Response System (IVRS), provide assistance on statistical aspects, and take part in the selection of a suitable vendor, if required.


    Alternatively we can carry out randomisation procedures and supply code break envelopes at a small fraction of the costs associated with IVRS systems.