The Clinical Submission Survival Manual – A Step-by-Step Guide to Effectively Communicating Your Data

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Review by Meredith Brown-Tuttle, RAC, FRAPS

Once again, 3D Communications has written another gem of a book that I will keep on my desktop for quick reference. This book guides the reader through preparing their clinical submission package for an NDA, BLA or PMA with the goal of optimizing preparation, reducing information requests (IRs) and minimizing the time to approval. That’s a lofty goal we all strive to achieve in any major filing or interaction, and now with fewer public FDA advisory committee meetings, submissions and earlier meetings with FDA are becoming more important than ever.

So how does 3D suggest we achieve this goal with our submissions?

• Outlines a proven process to create a credible clinical submission that communicates a positive benefit-risk by implementing solutions that overcome uncertainty and potential barriers to approval.

• Provides a framework on how to analyze what the FDA is both saying and implying, then how to use that in your messaging

Creating clear messaging around the interpretation of data is vital to the submissions success. 3D lays out the structure to help accomplish this by going over how to:

• Capture key messages, rationale, action plan, supporting data

• Understand risks to approval and label claims with selected key messages

• Make key messages easy to understand, convey all key information and quickly processed (use simple language, i.e. short sentences and active language)

• Use concise and information dense graphics to increase retention of information and support key message

• Decide when to bring in outside experts to test messaging and review content

Other points of interest include:

• Sample timelines from data to filing and milestones to hit

• Best practices for FDA Interactions:

• How to avoid common mistakes that companies make when communicating with regulators, so that sponsors can:

  • Cultivate a positive relationship with the FDA, one based on mutual respect, open communication, and cooperation

  • Initiate early and frequent dialogue

  • Listen carefully, without bias and an open mind, to the FDA’s concerns

  • Be transparent with the FDA about all issues and concerns and the plan to address them

  • Clarify comments and concerns when needed, don’t guess at intent

  • Understand precedent and how it might affect feedback received

  • Understand Division culture and topics of focus for the Division

  • Plan for all potential outcomes (think “Spider-Verse™” multiverse scenario planning) because the better a sponsor understands the FDA’s concerns, the better FDA can identify alternative proposals that might efficiently address the concern.

  • Plan, plan and then revisit the plan. Use the 3D ACT® Process to lay out clinical data messaging prior to data readout and then align with final data.

  • Create a process to objectively and comprehensively assess the available data, anticipate what the FDA will find most important and challenging, determine where the data gaps are, and decide what should be addressed proactively versus reactively.

The takeaway is, learn to tell an effective story about your data. Don’t hide anything, be upfront about all the issues and tie it all into the risk-benefit profile. Create your story in bite site chunks that are easily understood and supported by information dense but concise graphics that convey your message.

The wonderful guide includes case studies to help drive the point home.

The recommendations in this book are intended to help companies make the most of the body of data that has taken years and millions of dollars to generate for not just US companies, but all tips can be applied to global submissions as well. This book can help any member of the team responsible for interpreting and communicating the clinical data. This includes team members from clinical development, regulatory affairs, research and development (R&D), marketing, and communications, as well as executive management.

Meredith Brown-Tuttle, RAC, FRAPS, is the Chief Regulatory Strategist for Regulatorium, author of “IND Submissions: A Primer” and “Regulatory Intelligence 101” (1st and 2nd editions) and likes living on the cutting edge of regulatory intelligence and strategy tool development. She can be reached at Meredith@regulatorium.com.