The Single Arm Studies and What are the Alternatives?

• Are you seeing a return to single arm studies from an HTA perspective?
• What potential drawbacks should be considered when opting for non-randomized comparative trials instead of randomized control ones?
• If a full RCT isn't feasible, what other viable approaches are available as substitutes?
• How can sponsors best communicate their research with HTAs on these alternative solutions and explain the value they present in comparison to an RTC design study?

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