P118: Efficient, Accurate, and Precise: Data Monitoring Committee Summaries and Resulting Recommendations

Poster Presenter

Emily Woolley

Senior Director, Biostatistics
Axio, A Cytel Company
United States

Objectives

The objective of this poster is to provide points of consideration for efficient implementation of a Data Monitoring Committee (DMC) from operational and financial perspectives.

Method

DMCs review unblinded clinical trial data and issue recommendations regarding the risk/benefit of continuing a trial as designed. Consider which DMC services add the greatest value to your DMC, focus efforts for subsequent DMC meetings, and result in an efficient summary of the trial status.

Results

Summaries for DMCs should be specified at the outset to focus on key data relevant to the DMC’s remit. The time from data cut to DMC meeting should be minimized. This ensures any trends or concerns identified by the DMC are actionable. The type and quantity of data to summarize for DMC review directly impacts the time needed to prepare the summaries as well as the time needed by the DMC for their review. If the sponsor requires review or cross-validation, this adds to the time required between data cut and DMC meeting. In some situations, the time available for these activities is days or weeks and not months. Accurate and precise summaries are critical for the DMC to make clear, actionable recommendations.

Conclusion

Focusing the summaries ensures that the DMC’s review is not obfuscated by irrelevant data, that the summaries are easily digestible for the DMC throughout the life of the trial, and the summaries can be produced with quality in a reasonable time. This poster will present recommendations that optimize the experience for the DMC; result in reduced costs, timelines, and sponsor effort; and, ensure the DMC can provide the greatest value to the sponsor and trial participants. Examples include: 1) replacing a table of summary statistics over time and table of change from baseline summary statistics over time with a single boxplot with change from baseline overlaid, 2) replace four tables to summarize prior and concomitant procedures and medications with a single table of relevant concomitant medications, and 3) removing or substantively focusing dry runs for subsequent DMC meetings.