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Activity Number:
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131
- Topics in Clinical Trials
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Type:
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Contributed
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Date/Time:
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Monday, July 29, 2019 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #307147
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Presentation
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Title:
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Blinded Safety Monitoring in Clinical Trials and IND Safety Reporting: Challenges and Lessons Learned
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Author(s):
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Barbara Hendrickson*
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Companies:
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AbbVie
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Keywords:
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Clinical trial monitoring;
Blinded safety data assessment;
Safety assessment committee;
IND safety reporting
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Abstract:
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The FDA Draft Guidance Safety Assessment for IND Safety Reporting (2015) discusses the concepts of a Safety Assessment Committee (SAC) and Safety Surveillance Plan (SSP). Pilots employing a SSP and SAC were conducted. Anticipated adverse events (AE) were monitored in ongoing clinical trials by the product safety team using two statistical methodologies for blinded quantitative data assessment (novel Bayesian method or Sequential Poisson?based analysis). Safety concerns were referred to a SAC for unblinded evaluation to determine if a threshold for IND reporting was met based on aggregate data. Quantitative blinded AE monitoring was found to add value for programs with multiple ongoing blinded trials and larger numbers of serious AEs. Both statistical approaches generally led to similar conclusions regarding SAC referrals. Challenges were noted with identification of background reference AE rates. Multidisciplinary collaborative review of the blinded data and discussion with SAC of blinded data leading to event referral was vital. Communication between the SAC and data monitoring committee should be clearly defined. We will discuss pilot key lessons learned and recommendations.
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Authors who are presenting talks have a * after their name.
