In recent decades, innovative trial designs have been used as foundational evidence for novel treatments when traditional designs have been considered operationally challenging to implement.

These alternative approaches – including adaptive, basket, platform, hybrid, and enrichment trials – have gained popularity due to their ability to enhance trial efficiency, enable faster access to novel treatments, and provide robust, interpretable, and efficient data, without compromising on the quality of data needed for HTA approvals.

Despite the benefits, significant challenges remain as the relevance and scientific validity of innovative trial approaches are still being evaluated by regulators and payers.

We partnered with Novo Nordisk in a research project to examine payer perceptions of innovative trial designs across global markets, including the US, Japan, the UK, France, and Germany, focusing on where novel approaches may be considered appropriate. We sought to understand:

• How do different factors (e.g., disease prognosis) impact payer decision-making when innovative trial designs are presented?
• Under what circumstances (e.g., rare patient population) payers will accept innovative clinical trial design?

Hear Emil Nortoft, Global Market Access Director, Novo Nordisk give an oral presentation on the research results on June 17 at 3:55 PM UTC+1 at the HTAi conference in Saville, Spain.