For health innovators, trial selection is a key success factor as there are no second chances. But how do you find the optimal trial design to get your therapy to market? In the past, it was impossible to discover the optimal trial for a specific situation within a reasonable framework of time, as examining thousands of trial designs was simply not an option.
A small biotech innovator developing a new treatment for carcinoma recently approached Cytel for assistance with their trial design. Biotech sponsors often hesitate to use adaptive and innovative clinical trial designs due to the fear of operational complexities. This can often result in delays or increased development program costs, ultimately preventing patients from receiving breakthrough treatments for unmet medical needs.
The sponsor needed to balance innovative design with simplified operational approaches given their resource constraints. The design selection process needed to balance a wide choice of design options, given the complicated nature of the indication, and keep the operational characteristics of the clinical trial simple. Their conventional clinical trial design of 412 patients enrolled across 2.5 years was too expensive to implement—putting their innovative carcinoma treatment at risk.
The sponsor was looking to pursue a stage-gate funding approach which depended on cost-effective and strategically timed evidence collection paired with a reduction in trial duration—all while maintaining the probability of success. A well-timed interim look can supply potential investors with data unavailable at the beginning of a clinical trial, staging the investment and helping to mitigate the risks.
Working with Cytel, the sponsor was able to quickly identify the most efficient trial designs that required fewer sites and patients. Cytel’s Solara finds the optimal point for an interim look by sifting through a wide array of possibilities, thereby expanding funding options to bring a drug to market. The lower-expected budget and higher-expected investment obtained through the staged strategy secured more funding and ensured that a promising new carcinoma medicine had the best possible chance to reach patients more quickly.
When trying to land on an optimal clinical trial design the clinical development team is faced with decisions that could alter several key considerations of performance criteria: the speed of a trial, the clinical operations costs, the power of a trial. By activating the full power of biostatisticians, development teams using Solara can confidently select smarter statistical designs with the potential to benefit patients — and your bottom line.
Read the study to learn how you can use a stage-gated investment approach:
About the Author of Blog:
Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has 11 years of experience in handling various facets of marketing, across industries. At Cytel, Mansha is a Content Marketing Manager and is responsible for producing informative content that is related to the pharmaceutical and medical devices industries.