Whether we call it personalized medicine or precision medicine, there is an increasing need to account for issues such as:

• patient or disease genetic sub-types
• different severity of disease
• different populations – for example by ethnicity, age, or gender
• patients on different treatment regimes

These have a range of interesting problems from the point of view of designing and analyzing clinical trials.

• In different groups the control response may be different and the treatment response may be different
• The sub-groups may be of different sizes and significance

The simple solutions are to treat the groups as separate trials (inefficient, expensive and at times impractical), or simply to pool all the data (possibly sinking the drug with the mediocrity of its average performance). The talk will present some new approaches to designing efficient trials in these settings.

Speakers:

• Tom Parke, Principal Clinical Consultant for Life Sciences, Tessella

BIO

Tom Parke is a Consultant at Tessella. In 1998 Tom managed the development of the software systems to support the ASTIN Stroke trial. This trial, sponsored by Pfizer, managed by Dr Michael Krams and designed by Prof Don Berry and Dr Peter Mueller, was a landmark trial for its use of Bayesian modelling to guide the execution of the trial. The design optimized the allocation of subjects to doses and the decision of when and whether to stop the trial.

Tom has now helped implement a number of Bayesian adaptive phase 2 dose finding trials, for a range of pharmaceutical companies across a range of indications. For these trials, he has managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algorithms with existing IVRS and EDC systems.

He is currently leading projects within Tessella in partnership with Berry Consultants to industrialise this support for adaptive trials and he is consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities.

Before working at Tessella, Tom worked at Praxis (now part of Deloitte & Touche) most notably managing projects for part of the air traffic control system at Heathrow Airport, and control software for imaging systems for GE Medical Systems and Varian Oncology. Tom originally learned his software trade at inmos, and Imperial Software Technology developing compilers, operating systems, real-time kernels and the use of formal methods.