The Effective Statistician - in association with PSI

What is the ASAP and what you should know about it

Dec 11, 2023

Explore the new FDA DSUR reporting requirement and its impact. Learn about the expanded scope of the safety summary regulation. Understand the importance of comprehensive planning and ongoing safety assessments. Find out how to implement an effective safety process in companies. Connect with Greg for further assistance.

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Introduction

00:00 • 5min

FDA DSUR: Enhancing Safety in Clinical Trials

04:40 • 22min

Summary, Conclusion, and Proposed Rule

26:59 • 1min

The Importance of Comprehensive Planning and Ongoing Safety Assessments

28:28 • 14min

Implementing Effective Safety Process in Companies

42:34 • 4min

Connecting with Greg for Further Assistance

46:34 • 2min

Interview with Greg Ball

The US FDA has been advocating for aggregate program-level safety evaluations since 1988 when the ISS was introduced (the IND Safety Reporting Final Rule).
Aggregate data analysis looks at all available data holistically rather than relying on individual case reports. This allows for a more complete understanding of potential risks associated with a drug or vaccine.
In the near future, more companies will adopt a systematic approach to aggregate safety assessment planning and IND safety reporting.
This process will develop a better understanding of the safety profile of drugs and ensure that patients’ safety is well-thought-of.

Sources and references:

Ball G, Kurek R, Hendrickson BA, et al (2020). Global Regulatory Landscape for Aggregate Safety Assessments: Recent Developments and Future Directions. Therapeutic Innovation & Regulatory Science, 54(2):447-461
Ball G, Hendrickson BA, Freedman AL, Gordon R, Crowe B, Veenhuizen MF Buchanan J (2021). Interdisciplinary Safety Evaluation for Learning and Decision-Making. Therapeutic Innovation & Regulatory Science, 55:705-716.
Hendrickson BA, Wang WW, Ball G, et al (2021). Aggregate Safety Assessment Planning for the Drug Development Life Cycle. Therapeutic Innovation & Regulatory Science, 55:717-732.

Greg Ball

Owner and Consultant at ASAP Process Consulting

Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.