Rоctаviаn, like mаny оther gene therapies and оncology products, received market authorization from the FDA based primarily on single-arm trial data. In your view, what is the main problem with relying on single-arm trial data to assess the efficacy of a new treatment? To assess the comparative effectiveness of a new drug when only single-arm trial data is available, a common approach is to combine the single-arm trial data with a so-called external/historical control group. Describe why adding data from an external and/or historical control group may be relevant and what are the advantages and disadvantages with this approach? Your response should be 250 to 500 words (½ to 1 page).
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