The increase in single-arm trials poses challenges for health technology assessment (HTA) agencies as these studies provide limited evidence on the incremental clinical, economic and quality of life benefit of new treatments in comparison to standard of care.
The emergence of ‘synthetic control arms’ (SCA) is revolutionizing the acceptability of single-arm trials by reimbursement agencies. SCAs often involve harnessing real world data (RWD) from diverse sources.
There are several guidelines published by the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and National Institute for Health and Care Excellence (NICE) for pharmaceutical companies considering developing a SCA for HTA audiences. Whilst the guidelines are immensely helpful, a series of difficult decisions are still required to de-risk the SCA strategy and lay the foundation for a swift HTA acceptance.
Download to learn about the multifaceted trade-offs between strategic and data partnership decisions which are required when developing a SCA for HTA agencies. Prioritizing what is acceptable by HTAs and not being constrained by trying to achieve perfection when it comes to identifying the ‘right data’, the ‘right engagement’, and the ‘right operations.’
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