A good clinical study design performs well not only under the ideal target scenario. Statisticians should be able to adjust and update strategies as new desirables are revealed, showing executives how a clinical trial could be de-risked. Ideally, they would want to look at the full map of possibilities and find the best design that fits the needs, priorities, and the business objectives of the company. Trying to do this in near real time is very challenging, as the lack of time and tools can prevent most sponsors from finding the optimal design options for their study.
The growing adoption of innovative clinical trial designs also require tactical deliberation on necessary tradeoffs between parameters such as greater study power, smaller sample size and accelerated timelines. A common challenge in understanding these tradeoffs involves determining which set of clinical trial designs to evaluate, when making strategic decisions. about these parameters.
Despite the challenges, the use of statistical innovation can help us create more efficient clinical trial models, leading to superior results. An innovative design can help determine funding opportunities, conserve resources, clarify target populations to help with market access, choose endpoints and add more valuable insights. With the advent of cloud-based computational power, trial analysis that would take weeks or months can now be completed in hours. This helps to remove the barrier to exploring complex innovative designs that can help the trial reach its goal sooner.
In a recent webcast with Applied Clinical Trials, Yannis Jemiai, Cytel's Chief Science Officer reveals how trial sponsors can leverage Solara to quickly explore millions of trial designs through advanced simulation methods and answer some of the key clinical strategy questions including - How can different trial performance characteristics be weighted against each other in a quantifiable manner?
Dr. Jemiai has worked extensively on how to operationalize decision theoretic tools for clinical development decision-making. During the webinar, he introduces the quantitative frameworks that life-sciences decision-makers can incorporate into their selection process when selecting an optimal design for their next clinical trial. Pareto Frontiers and scoring algorithms are two such methods available in Solara that can quickly identify the set of designs that have been optimized for speed or power, and then rank ordered in accordance with a range of sponsor goals from anticipated return on investment to proof of therapeutic value.
Solara: A Clinical Trial Strategy Platform
Solara is an innovative trial strategy platform that combines massive cloud computing with Cytel algorithms to dramatically expand available design options for confident selection of optimal clinical trial design. With great multitude of options available to explore, new tools are required to support wise decision-making and arrive at the optimal design.
Watch the on-demand webcast to see how Solara can empower your clinical strategy.
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.