Tessella has launched its Seamless Phase 2/3 Simulator, at the Clinical Trials Congress in London, to better equip the pharmaceutical community to carry out seamless adaptive clinical trials
A seamless trial involves what would normally be two, consecutive, separate clinical trials being run back-to-back without a pause.
Broadly the same protocol is used for both stages, with some limited adjustments made at the end of the first stage based on the results obtained so far.
Tom Parke, Tessella's head of clinical trials, explained; "A seamless trial might combine phase 2a (proof of concept) and phase 2b (dose finding), or phase 1 (safety study) and phase 2a, but it is the idea of combining phase 2b and phase 3 that has engendered most interest in the pharmaceutical community.
"These are usually the largest and most expensive trials in a drug's development".
Tom Parke continued: "Whether planning an actual seamless trial or simply evaluating the potential of seamless trial designs, it is essential to have the ability to simulate trials using seamless designs.
"This is exactly what Tessella's Seamless Phase 2/3 Simulator enables".
Embarking on a seamless phase 2/3 trial will be more expensive than starting on the phase 2 alone; in particular more compound must be manufactured and more investigating centres may be required at the outset.
More importantly however, there will be no opportunity to re-design the protocol for phase 3 based on the data accumulated in phase 2.
Regulators will need to be convinced that the risk of a re-design being required will be low.
There are, however, a number of situations where this risk is likely to be acceptable or even preferable to the alternative.
Peter Townsend, commercial director of Tessella commented: "Since 1998, Tessella has been helping to drive innovation in drug development by enabling the deployment of adaptive clinical trials.
"In collaboration with leading statisticians, Tessella has implemented statistical models for phase 1 trials, phase 2 dose finding studies using Bayesian statistics, and phase 2/3 seamless designs.
"Tessella has supported these models by developing simulation and analysis tools, and by building and running the infrastructure to run the trials.
"Such infrastructure has included central randomisation, electronic data capture, and drug supply management.
"Tessella has also provided consultancy to pharmaceutical companies to help them adopt adaptive clinical trials and to enhance their own in-house systems so that they can support adaptive clinical trials".
Kevin Gell, managing director of Tessella added: "In the highly competitive life sciences sector, companies of all sizes need an edge.
"Tessella has been a leading independent supplier of software solutions to the pharmaceutical and biotech communities for many years, priding ourselves on understanding our clients' business and technical requirements, and working with them to provide innovative, cost-effective solutions."
