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Protocol Synopsis

The initial, high-level concept stage. Feasibility at this point is about the big picture: Is the scientific question sound? Is there a plausible patient population? What are the major, obvious roadblocks? It’s a quick check to see if the idea is worth pursuing further.

Key Activities
  • Performing comprehensive literature reviews to understand the current research landscape.

  • Conducting high-level discussions with Key Opinion Leaders (KOLs) to gather expert input.

  • Completing a market analysis to assess the potential impact and commercial viability of the proposed trial.

Common Challenges
  • A vague or poorly defined scientific premise can lead to a lack of focus.

  • Overestimation of patient availability based on incomplete data.

  • Ignoring the commercial or clinical relevance of the research question.

Put it into Practice

Use the AI Assessment tool to quickly evaluate the viability of your initial trial concept.

Run a High-Level Assessment