This past decade has undoubtedly witnessed an increase in the number of single arm trials submitted to HTA bodies. Given the rise in pivotal single arm trials approved by both US and EU regulatory bodies, HTA authorities are more often required to make the complex decision of accepting HTA submissions based on their findings. According to recent estimates, at least 400 single arm studies have been submitted to health technology assessment authorities since 2011.
Yet many questions remain about the best way to conduct single arm studies. At this year’s ISPOR conference, scientists at Cytel will be leading critical discussions about open questions for an impactful single arm study, and presenting some roadmaps to potential solutions.
Dr. Grammati Sarri, Lead Scientist at Cytel, will lead an issue panel entitled, “Is the Global Real World Data Supply Chain Broken?” In the context of this question, she will ask whether quality or locality is a more critical feature of building strong single arm HTA submissions. After all, it is possible to build a control arm from a single data source, but how convincing is this likely to be for HTA authorities?
Dr. Grammati’s exciting issue panel has also been selected as a part of ISPOR’s RWE Subprogram. In recognition of the expanding role of real world evidence in regulatory and HTA, the RWE Subprogram of ISPOR 22 features a select number of spotlight sessions, workshops and of course, issue panels, on methods and applications of RWE.
Other important issue presentations led by Cytel experts at this year’s ISPOR include Dr. Eric Mackay on ‘Power Implications of Estimator Choice in Synthetic Control Arm Analyses’ and ‘Studies on COVID-19 Healthcare Impacts’ by Rachel Knapp, MPA.
For a full list of Cytel presentations, please see below.
Cytel will be at ISPOR in person in 2022. Please visit us at Booth #725.
About the Author of Blog:
Dr. Esha Senchaudhuri is a research and communications specialist, committed to helping scholars and scientists translate their research findings to public and private sector executives. At Cytel Esha leads content strategy and content production across the company's five business units. She received a doctorate from the London School of Economics in philosophy, and is a former early-career policy fellow of the American Academy of Arts and Sciences. She has taught medical ethics at the Harvard School of Public Health (TH Chan School), and sits on the Steering Committee of the Society for Women in Philosophy's Eastern Division, which is responsible for awarding the Distinguished Woman in Philosophy Award.