When preparing for a meeting with the FDA, most Sponsors focus on regulatory affairs, clinical leads, or medical officers. However, one role that is becoming increasingly central and often overlooked is the statistician. Whether preparing for a Type B meeting to discuss a pivotal trial or seeking alignment on a protocol or statistical analysis plan, having the right statistical expert at the table can make or break your regulatory interactions. A strategic statistician’s mission aligns with that of FDA in its objective to measure, analyze, and interpret scientific evidence, providing a quantification of risk to facilitate regulatory decision-making.
Why Having a Strategic Statistician Matters in FDA Meetings
FDA reviewers do not simply look at results from clinical trials. They assess the validity of your statistical approach, the assumptions underlying your analyses, and the strength of your conclusions. Below are three critical ways a strategic statistician adds value:
They Can Defend the Study Design and Data Analysis Methods
Effective statisticians can clearly articulate and defend:
- The choice of primary and secondary endpoints
- Sample size
- Handling of missing data
- Adjustments for multiplicity
- Modeling approaches (e.g., MMRM, Cox models)
FDA will scrutinize these choices, and a strategic statistician who understands regulatory expectations ensures that your design and methods, especially innovative ones, hold up under examination. FDA seeks to understand how the methods used by the statistician minimize bias and the effectiveness of these methods both before and after the clinical trial is complete. Additionally, FDA will inquire about the methodological assumptions, any violations, and the impact of these violations, as well as the results of supplemental analyses that offer better interpretation of the study findings. In essence, it is not just about crunching numbers and reporting p-values.The study design and interpretation of clinical trial results within a broader, more rigorous context aids FDA in understanding clinical trial outcomes.
They Can Communicate Complex Concepts Clearly
Top statisticians excel at simplifying complexity. In regulatory meetings, strategic statisticians can explain why, for example, a non-inferiority margin is appropriate or how intercurrent events were handled. They use various techniques, such as graphs and tables, to help all participants, beyond the FDA statistician, understand complex statistical methods, clinical trial result patterns, and data interpretations, keeping the broader picture in mind. Facet’s 14 years of experience show that this ability is directly linked to success in FDA meetings.
They Can Respond to FDA Questions in Real Time
FDA meetings often involve on-the-spot questions such as:
- “What would the power be if you used a different endpoint?”
- “How sensitive is your primary result to different assumptions about missing data?”
- “Please explain why you are using MMRM instead of mean imputation for missing data?”
A skilled, strategic statistician can answer these questions and more with credibility and competence, strengthening your position and demonstrating objectivity and scientific rigor. Having a statistician present during the meeting also allows for immediate responses to FDA queries and the opportunity for a productive discussion, rather than relying on less desirable post-meeting follow-ups.
What if I Do Not Have a Strategic Statistician on My Team?
Most companies lack strategic statisticians with deep methodological, statistical, and regulatory expertise. Contracting with an experienced statistical consultant, particularly one with FDA meeting experience, offers several unique advantages.
Support to Expedite Development and Save Money
A strategic consultant with substantial methodological expertise gained from working with many Sponsors can help advise on the most effective clinical trial designs, such as traditional, adaptive, basket/umbrella, and seamless, and enrichment methods. Innovative trial designs can enhance data quality, reduce costs, and improve efficiency. Experienced statistical consultants also help identify efficacy and safety endpoints that target therapies more precisely, reducing the number of patients needed to achieve statistically significant results. Additionally, they leverage innovative statistical methods to increase power, predict outcomes with greater accuracy, or apply prior knowledge and experience to better understand data patterns and relationships.
Regulatory Know-How
A statistical consultant brings valuable insight from past FDA interactions across multiple therapeutic areas. They understand FDA reviewers’ perspectives and can anticipate objections before stepping into the room. Their expertise helps FDA’s non-statistical reviewers understand the methods and complexities of a trial, preventing additional content-related questions before they arise.
Objective Review of Your Plans
Statistical consultants also offer unbiased feedback on your trial design and statistical analysis plan. Their external perspective allows them to spot issues that internal team members may overlook, providing an objective interpretation of data. They can help you avoid sticky situations with regulators and can ensure that you obtain clear and actionable feedback from FDA.
Preparation for the Meeting
A good statistical consultant will assist you with:
- Drafting and refining FDA questions and background package sections
- Preparing mock FDA Q&A sessions
- Ensuring your statistical methods, results, and interpretations are regulatory-grade
Credibility and Confidence
Hiring a recognized, experienced statistical consulting provider signals to FDA that your protocol, statistical analysis plan, and final study report have been thoroughly vetted. It also boosts your internal team’s confidence in handling technical questions.
When to Engage a Statistical Consulting Provider
Ideally, a strategic statistician should be involved early, well before FDA meetings:
- During protocol development
- When drafting the statistical analysis plan (SAP)
- While preparing the meeting request and background package
Even if you already have internal statisticians, a statistical consultant can serve as a second set of eyes and bridge the gap between clinical trial design, interpretation, and regulatory strategy. Often, statistical consultants have vastly greater exposure to different study designs, efficacy and safety measures, and interactions with FDA than Sponsor statisticians who might work on only one or two programs in their career. That experience can be leveraged to give you and your program the best chances for success.
Facilitating FDA Success with Facet’s Strategic Statistical Consulting Expertise
The role of the strategic statistician in FDA meetings is no longer optional, it is essential. Regulatory success depends not just on clinical data but on the statistical narrative behind it. Hiring a strategic statistical consultant ensures that you are putting to work vast amounts of industry experience to tell your products’ story in the right way to the right audience. Learn how Facet’s expert statistical consultants can help you tell a better story to boost your chances of product success!
On the topic of stretching – I’ve decided that it couldn’t hurt, I just need to remember to do it!
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