By Yannis Jemiai, Esha Senchaudhuri, Susan Feury, Joshua Schultz
Research described at a recent DIA conference on Complex Innovative Design noted that the integration of innovative trial designs with other drug development tools and best available technology can save a program 20-30% in time and cost. Yet, despite the emergence of these more innovative trial designs, the average time it takes for a drug to reach the market has stagnated at 6 years, while the success of Phase 3 trials has hovered at about 30-35% for the past decade. The promise of adaptive designs that provide flexibility in the face of uncertainty remains largely unfulfilled.
We wondered if adoption of these efficient design methodologies was the issue. A recent survey conducted by Cytel found that only 42% of respondents reported using any complex or adaptive designs beyond the most widely adopted group sequential approach. While regulatory and operational barriers remain a cause for concern in the sphere of research and development, there is mounting evidence that regulators will accept well designed flexible studies that put patients first. There is even more evidence that clinical operations teams can rise to the challenge. There are a growing number of drug approvals, for example, which include adaptive designs for regulatory findings, even for pivotal studies.
So what has prevented the adoption of these new methodologies? Cytel’s research uncovered that teams confronted with the need for innovative trials that employ advanced methodology often find difficulty exploring and communicating trade-offs in cost, time and probability of success. Whereas statisticians previously needed several days to make these calculations, the advent of cloud-computing has now made it possible to make these calculations rapidly. Cytel’s trial simulation platform SolaraTM, for example, can calculate in fewer than 30 minutes what would have taken 500 hours only a year ago.
What Development teams now need in the Age of Cloud Computing is a process that allows new technology to explore more designs strategically. In response, Cytel’s developed a new Advanced Design Framework for the Re-imagined Clinical Trial.