Clinical Events Committees (CEC)

Jul 24

Since 1986, Biomedical Statistical Consulting® has guided hundreds of medical device companies through FDA submissions. Many of these trials have included Clinical Events Committees (CECs).

For medical device sponsors racing toward regulatory approval, Clinical Events Committee (CEC) design isn't just a compliance requirement—it’s a strategic decision that can play a fundamentally important part in your trial’s regulatory fate. The FDA’s evolving expectations mean that simply having a CEC is no longer sufficient. You need one that regulatory reviewers trust.

What Is a Clinical Events Committee?

A Clinical Events Committee (CEC) is an independent panel of clinical experts that adjudicates adverse events, neurological status, protocol deviations, and other critical endpoints in clinical trials. Its purpose is to ensure consistent, objective assessment of trial data and help minimize (intentional or unintentional) investigator bias or sponsor influence.

Why This Matters for Device Sponsors:

FDA reviewers scrutinize CEC independence and methodology
Poor CEC design can trigger formal rejection letters
The right CEC structure accelerates approval timelines
Independent oversight reduces regulatory risk

The Evidence: Independent CEC’s are important

BSC®'s landmark research, Mitigating Adverse Event Reporting Bias in Spine Surgery, published in The Journal of Bone & Joint Surgery, revealed systematic patterns in adverse event reporting that every device sponsor must understand.

Key Findings:

Independent reviewers reclassified 37% of adverse events originally categorized by study investigators
92% of reclassifications involved upgrading severity or device-relatedness
Industry-sponsored studies are 3.6 times more likely to report positive outcomes than independent research

This research, led by BSC®'s Chief Scientific Officer, Greg Maislin, represents the first quantitative analysis of investigator bias in medical device trials. The findings support having CECs and their ability to improve clinical research.

FDA Regulatory Evolution: What Sponsors Must Know

The FDA continues to evolve its thinking on CEC, with greater emphasis on CEC credibility and independence. We have seen the following recent regulatory actions:

Formal rejection letters stating reviewers "do not believe your CEC."
Heightened scrutiny following controversies in orthopedics and spine.
Demands for transparency in adjudication processes.
Requirements for statistical oversight to detect reporting bias.

The New Reality: Simply having a CEC is no longer enough. It’s about having the “right” committee and process.

The Independence Challenge: Make sure your CRO provides a conflict-free process

Many sponsors outsource CECs to full-service Contract Research Organizations (CROs). This can create important efficiency gains, decrease costs, and shorten timelines. However, not all CROs are created equal.

Potential Problems:

CECs can not compensate for a lack of consistent and on-going site monitoring. CECs should not be used as a swiss-army-knife.
CROs that consider CECs as a scalable revenue stream.
FDA reviewers question CRO-managed CEC independence

The Solution:

A truly independent CEC should include:

Clinicians with no financial relationship to the sponsor
Clinicians with no financial relationship to the full-service CRO
Pre-specified and transparent adjudication process

CEC Framework: Designed for FDA Success

Our 35+ years of FDA experience have taught us that successful CECs require:

Therapeutic Expertise Without Conflicts

Adjudicators familiar with your device
No financial relationships that could compromise objectivity
Specialized knowledge of regulatory clinical trials

Pre-Specified Adjudication Process

Event categories are defined upfront
Clear algorithms for classification decisions
Documentation aligned with FDA expectations

Transparency and Documentation

Auditable processes that can withstand FDA scrutiny
Comprehensive reporting for regulatory submissions
When requested, independent statistical oversight

Strategic Implications for Device Sponsors

Early CEC decisions can define your trial's regulatory fate. FDA rejection doesn't just delay timelines—it can compromise:

Fundraising and investor confidence
Partnership negotiations
Commercial positioning and market entry
Competitive advantage

Key Principles for Success:

1. Start Early

Design the CEC structure during protocol development
Pre-specify adjudication process before first patient enrollment
Ensure independence from trial management

2. Choose Expertise Over Convenience

Just because they are recommended by your CRO does not mean they are appropriate for your trial
Therapeutic expertise must be conflict-free
Process transparency is essential

3. Plan for FDA Scrutiny

Document every decision and rationale
Maintain auditable processes
Prepare for detailed reviewer questions

Moving Forward: Your Next Steps

The evidence is clear: CEC design is a strategic decision that requires regulatory expertise. Device sponsors who invest in credible, independent oversight are more likely to achieve approval.

[1] Auerbach, Joshua D. MD1; McGowan, Kevin B. PhD2; Halevi, Marci BS3; Gerling, Michael C. MD4; Sharan, Alok D. MD5; Whang, Peter G. MD6; Maislin, Greg MS, MA7. Mitigating Adverse Event Reporting Bias in Spine Surgery. The Journal of Bone & Joint Surgery 95(16):p 1450-1456, August 21, 2013. | DOI: 10.2106/JBJS.L.00251 https://journals.lww.com/jbjsjournal/abstract/2013/08210/mitigating_adverse_event_reporting_bias_in_spine.2.aspx

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About BSC®

Our track record speaks for itself:

35+ years of successful FDA submissions
Hundreds of studies across medical device categories
Published research on CEC best practices
Long-standing FDA relationships and panel meeting experience

We don’t provide complete CEC services. We are happy to connect you with strategic partners who do. We do offer independent statistical consultation of CEC proposals, and provide CEC statistical advisory services to ongoing CECs.

We design regulatory strategies that position your trial for FDA success. Our independent statistical oversight and therapeutic expertise ensure your CEC meets the FDA’s evolving expectations.

Biomedical Statistical Consulting® has guided medical device companies through FDA submissions since 1986. Our expertise in best practice for CEC and DSMB design and independent statistical oversight has supported hundreds of successful regulatory approvals.

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