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The Impact of Clinical Development Decisions on Time to Market and Development Risk in Oncology 

Key Findings
• Every month a programme can accelerate to market adds an estimated $5–6M of net present value per billion dollars of peak year sales
• We have identified clinical development decisions that entail trade-offs in accelerating time to market and increasing likelihood of approval
• We have identified common clinical development decisions that have a relatively neutral impact on time to market and likelihood of approval
• We have examined skipping trial phases and aggregating trial phases, which have disparate impacts on time to market and likelihood of approval

Why Time to Market Matters in Oncology Drug Development
Innovation in oncology R&D has been driven both by advances in basic science (e.g., improved understanding of hallmarks of cancer) and steadily increasing biopharma R&D investment (see Figure 1). This growing investment has been justified by oncology’s position as a therapeutic area that offers an efficient path to marketable drugs, driven by a high percentage of unmet needs and relatively short development times

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