Nmblr Proof Step 2: Evidence Gaps

How to run it (facilitator guidance)

1. Invite contributions by KBQ

For each KBQ, ask:

“What evidence do we have now—or know is in progress—that helps answer this?”

Prompt for breadth, not just clinical trials:

• clinical study data (completed or interim)
• RWE / registries / claims / EHR analyses
• HEOR / cost-effectiveness / budget impact
• PROs / QoL / patient preference
• publications / abstracts / congress posters
• competitive evidence benchmarks, meta-analyses, guidelines

2. Capture the evidence in a usable way

Have contributors note (lightweight is fine):

• Evidence
• Type (category)
• Source
• Status (available now vs. in progress vs. planned)

3. Run the “gap test” question

Before declaring a gap, ask as a team: “Does this evidence satisfy the answer to the KBQ?”

• If yes → you may be covered (or partially covered).
• If no → you have an evidence gap to carry forward.

A helpful way to keep discussion productive:

• Fit: Does it match population/comparator/endpoints/timeframe?
• Credibility: Would the intended stakeholder accept it?
• Timing: Will it be ready when the decision is made?

4. If there is a gap, capture it so it’s actionable

When you flag a gap, document three things immediately:

• Gap description: What is missing, specifically, relative to the KBQ?
• Needed by when: What’s the decision-use date?
• Where it must be acceptable: Which countries/markets must accept this evidence?

Output

For each KBQ:

• Gap description + category + needed-by date + acceptable countries