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Anna Forsythe on Aligning Clinical Strategy with Regulatory and Market Objectives

Sponsors bringing a successful new product to market have to overcome two hurdles: submission and reimbursement. For regulatory bodies, the focus of such submissions is on the safety and efficacy of the new products. Whereas, reimbursement organizations are focused on the value added relative to what is on the market – particularly, with regards to patient impact and costs to healthcare systems. In some cases, regulatory and market access bodies also make assessments based on different endpoints. As a result, the regulatory requirements and the market access requirements are not always the same or even aligned to one another. Many sponsors create two unique strategies for evidence submission for each of these cases. Hence, we often see a disconnect between the teams that handle regulatory submissions and market access.

This divide can often lead to potential evidence gaps that arise while preparing clinical programs that are not sufficiently strategized. To avoid this, the strategic conversation about evidence generation needs to begin much earlier - when a company is planning the pivotal trials that will potentially be used for registration.

In a recent podcast with Clinical Research News, Cytel's Vice President of Value and Access, Anna Forsythe advocates for combining the two evidence generation processes. She elaborates on how this will enhance the findings of both, streamline evidence generation through more strategic clinical operations, and overall lower costs and accelerate timelines. In addition, in therapeutic areas where the evidence standards have to keep up with an evolving industry, aligning these two can anticipate changes.

Modern software solutions can enable both large and small companies to generate the right evidence and efficiently plan their studies. For example, Cytel’s LiveSLR software is a curated library of clinical and payer relevant evidence that is updated in real time. Powerful machines help our experts extract and identify critical evidence for always up-to-date databases and real-time reporting.

Conventional SLRs that are perhaps annually updated are unable to capture relevant, newly published evidence. Additionally, sponsors also need RWE as it is an important source of data, beyond clinical, QOL, and economic studies, to support the value of a new product. LiveSLR offers a curated database that can be searched by indication or interventions or study types (Economic, RWE, RCTs, etc.) or GVD-relevant chapter (Epidemiology, treatment patterns, comparative effectiveness, etc.).

Another technology innovation by Cytel is Solara™, a clinical trial strategy platform that unifies statistical design and clinical strategy to improve clinical development productivity. It combines massive cloud compute with Cytel algorithms to dramatically expand available options for confident selection of the optimal clinical trial design. Together, Solara and LiveSLR allow the members of the drug development team to assess the up-to-date scientific evidence by indication, and then utilize that evidence into methodically examining each relevant trial design, run a multitude of iterations, and come up with the ultimate design for their specific drug. They can be used to ensure that correct and sufficient forecasting is performed and sufficient evidence is generated to increase a therapy's probability of success.

Watch the podcast to learn more.


Our experts our looking forward to meeting attendees at the upcoming 63rd ASH Annual Meeting and Exposition onsite and virtually. Contact us to book a meeting with a member of our global team to learn how Cytel is redefining clinical trial design & strategic evidence planning for successful regulatory and reimbursement submissions with LiveSLR and Solara.


About the Author of Blog:

Mansha Sachdev specializes in content creation and knowledge management. She holds an MBA degree and has over 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.


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