Tony O'Hagan - Consulting

Consultancy in drug development

My expertise

My expertise in this area lies in modelling and simulation to help with the design of individual trials and sequences of trials. I have developed the Bayesian clinical trial simultation (BCTS) method, along with theory for trial design that recognises both the requirements of regulators and the internal company needs, expectations and values.

My clients

I have so far consulted primarily with AstraZeneca on these methods, including the creation of a complete drug development information system in one therapeutic area.

Typical challenges

Drug development is hugely expensive, and constrained by numerous regulatory requirements. In an increasingly risk-averse world, drug companies are under pressure to deliver more and more evidence prior to regulatory approval and reimbursement. In this climate, companies are seeking ways to run more efficient trials, that minimise cost while at the same time allowing better and earlier discrimination between compounds for potential clinical and economic success. I can offer expertise in modelling the clinical development through from phase 1 to phase 3, licensing and reimbursement. Experience so far suggests that this leads to important insights and opportunities for more efficient drug development programmes.

Even designing an individual trial is a complex business, particularly at phase 3, where likely outcomes are influenced not just by raw sample size but also by a host of other factors - the use of interim and futility analyses, the recruitment schedule, choice of comparators, adaptive design features and phase 2/3 combinations, etc. Clinical trial simulation attempts to compute power and other features for alternative complex designs. However, conventional clinical trial simulation fixes numerous parameters that, whilst not random, are still uncertain - the drug's efficacy, baseline incidence, compliance and drop-out, adverse event rates, etc. Interpreting the answers from alternative parameter specifications can be very confusing. My pioneering BCTS approach addresses these challenges in a way that delivers much clearer, more relevant information to decision-makers.

I am happy to consult on these or other problems in the design of drug development programmes.

Updated: 18 January 2017

Maintained by: Tony O'Hagan