A staged investment strategy aligns R&D decisions and financial planning with the interim looks of a clinical trial. If well-crafted, it can help to generate higher levels of funding for small sponsors by sharing greater evidence of probability of successful outcomes. However, it requires both planning for interim looks and determining ideal timing. 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.
A small biotech sponsor developing a new treatment for carcinoma approached Cytel to leverage Solara to assist with their trial design. The sponsor was working with a limited R&D budget and was facing challenges in gathering the evidence in a cost-effective manner. A wide choice of design options had to be carefully evaluated considering the complicated nature of the indication.
The sponsor’s conventional clinical trial design of 412 patients enrolled across 2.5 years formulated a baseline design that was too expensive to implement. With Cytel’s help, the sponsor was able to use the stage-gate approach which not only helped to lower the overall cost of the study but also, increased their chances to secure funding from investors.
Cytel’s trial design experts presented a narrowed set of design options to the sponsor’s medical and clinical operations team, simplifying the operational challenges that the team would need to face in executing the study. The partnership helped the sponsor to zero in on a design that accommodated their evolving R&D priorities and limited resources, while minimizing the forthcoming executional risks. The reduced estimated costs and higher opportunity for securing more investments through staged strategy, ensured that a promising new carcinoma drug had the best possible chance to quickly reach patients.
An effective innovative therapy can be denied to patients simply because traditional trials are too difficult to fund. Staging investment ensures that information obtained at an interim look can generate higher returns for investors and thereby, attract funding to test the efficacy of novel therapies. In this case, Cytel’s Solara was able to help the sponsor identify an innovative design that is simple to operationalize.
Solara, a clinical trial strategy platform, combines massive cloud compute with Cytel algorithms to dramatically expand available design options for confident selection of the optimal design. Unifying statistical design and clinical strategy to improve clinical development productivity, Solara helps teams control uncertainty, minimize costs, and accelerate speed to market.
Read the study to learn how Solara can help you to secure funding for your innovative therapy:
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.