American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan-Kettering Cancer Center
Biostatistics Seminar



Josť Pinheiro
Janssen Research & Development
Johnson & Johnson

SAFETY MONITORING AND EVALUATION
IN LATE PHASE CLINICAL DRUG DEVELOPMENT

Regulatory agencies have shown increasing concern about potential, specific (usually rare) safety signals during clinical drug development. Entire classes of drugs have been placed on clinical hold because of such concerns, with regulators requiring safety monitoring rules for reducing patient risk in ongoing development programs as a pre-condition for lifting the clinical hold. Multiplicity issues arise naturally in this context, both from the repeated looks into accumulating, unblinded data, but also due to the various studies included in a program. From a regulatory perspective, the associated false positive rate is less of a concern, but from the sponsor point-of-view, it can make investing in the development program unfeasible. This talk will describe the experience of developing a safety alert rule in a late phase clinical development program, presenting different alternatives considered and their respective operating characteristics at the trial and program levels. More generally, the issue of safety signal detection vs. demonstrating lack of a clinically relevant safety signal will be discussed in the context of safety monitoring strategies to achieve a balance between protecting patients and keeping drug development economically viable.

Joint work with Camille Orman, Steven Wang, and Elena Polverejan, Janssen R&D.


Date: Wednesday, February 20, 2013
Time: 11:00 A.M. - 12:00 P.M.
Location: Memorial Sloan-Kettering Cancer Center
Department of Epidemiology and Biostatistics
307 East 63rd Street
(between First and Second Avenues)
3rd Floor Conference Room
New York, New York
Note: To gain access to the building, please follow the directions by the telephone in the foyer.

RESERVATIONS ARE NOT REQUIRED


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