Medical and Pharmaceutical Statistics Research Unit

The Medical and Pharmaceutical Statistics (MPS) Research Unit was established by Professor John Whitehead and Professor Anne Whitehead at The University of Reading, UK in 1994. In 2007, the Unit relocated to Lancaster University, where it is part of the Department of Mathematics and Statistics.

The Unit exists to develop and evaluate novel statistical methods of study design and data analysis relevant to pharmaceutical companies and medical research institutes. MPS undertakes methodological research, often in direct collaboration with companies, and provides professional development courses and a consultancy service.

Our main areas of research and expertise are

• statistical methods for dose-finding studies,
• proof-of-concept studies,
• adaptive designs for clinical trials,
• ordered categorical data,
• survival data,
• meta-analysis of clinical trials,
• modelling pharmacokinetic and pharmacodynamic data and
• statistical methods in pharmacogenetics.

Research in these areas has given us extensive experience of dealing with issues of multiplicity and of devising and applying Bayesian approaches to clinical research. We use simulation extensively to verify the accuracy of asymptotic results for the moderate sample sizes encountered in practice. Our pharmacogenetics projects have involved data on large numbers of SNPs, and the associated multiplicity problems. MPS is keen to jointly explore other methodological areas with collaborating companies, but cannot claim specific expertise outside the listed topics.

Collaborations with the pharmaceutical industry range from providing advice and consultancy over the course of a few days to the joint development and publication of novel methodology in research partnerships that last several years. Experience with regulators has included attendance at meetings to discuss design issues, participation in teleconferences and correspondence about protocols and attendance at final licensing hearings. Most of these contacts have concerned the FDA, but others have been with European agencies. Our professional development courses are aimed at graduate level statisticians with experience in the industry, and are scheduled in Lancaster as well as being available for presentation at a client’s own site.