Seminar #68: The use of control charts to track adverse events in clinical trials
This seminar is represents my attempt to outline some of the issues facing Institutional Review Boards (IRBs) as they provide continual monitoring of clinical trials. There are several important questions that they face:
- Is the accrual rate lagging to the point at which you might want to question the ability of the research to meet its planned goals?
- Is there an unusual rate of dropouts in the trial which might compromise the quality of the research?
- Is there an unusual and unexpected number of adverse events in this trial?
- Are there disparities in accrual, dropouts, and adverse events between the two arms of the trials.
Most IRBs are uncomfortable with their role in ongoing monitoring, and they often provide only a qualitative assessment at their continual review.
I'm thinking about writing a grant that would use control charts for the ongoing monitoring of clinical trials. The control charts would supplement the qualitative assessment at continuing review with some hard numbers. I want to develop some simple and useful charts that would track trends in accrual, dropouts, and (most importantly) the accumulation of adverse events in clinical trials. entry. This seminar will outline some of my initial efforts, focused primarily at the assessment of accrual rates.
I would greatly appreciate any feedback or assistance as I develop these ideas further.