The independent statistician model: How well is it working?

Abstract

With the initiation in the late 1960s of the data and safety monitoring board or equivalently the data monitoring committee in randomized clinical trials came the need for interim statistical reports for these committees to review for study conduct and early evidence of harm or overwhelming evidence of benefit, perhaps leading to early trial termination. Initially, the statistical team was part of the data coordinating center for the trial. Later, starting in the early 1990s in many industry-sponsored trials, this statistical unit was separated organizationally from the team that collected and managed the data. This unit, often referred to as the statistical data analysis center, prepares reports for the data monitoring committee, which cover study conduct, data quality and completeness, primary and secondary outcomes, and safety measures by study arm in an unblinded fashion. The role of the statistical data analysis center is critical to any well-functioning data monitoring committee. With the proliferation of data monitoring committees has grown the need for many more well-trained and experienced statistical data analysis centers. In my experience, some such units perform their tasks extremely well but many do not. There is a tremendous need and opportunity to provide training for statistical data analysis centers, and what sponsors and data monitoring committees should expect from statistical data analysis centers.