It is appreciated that there may be significant differences in clinical outcomes comparing how a drug performs in a well-controlled trial compared to how a drug performs in routine clinical practice, i.e., in the “real-world.” An NDA data package compile comprehensive, well controlled, data essential for the FDA and other regulatory review bodies to assess authorization for marketing; yet it may be incomplete for other key stakeholders, such as 3 rd party payers and some needs of patients and prescribers.
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The sentences
Seamless and Adaptive Trial Design in Oncology There is a strong trend in oncology drug development that distinct demarcations between defined clinical development phases are being replaced by a seamless continuum of development.