Key Performance Indicators (KPIs) & Metrics Project: Year 1 Report

The KPIs & Metrics project team consisted of volunteers from across the pharmaceutical industry under the leadership of Co-Leads Yvonne Moores and Andy Richardson.

The full list of contributing volunteers can be found here.

The KPIs & Metrics project was initiated to develop, collect and publish a set of data reporting metrics, measuring the quality, efficiency and duration of the tasks that fall under the statistical programming umbrella. The initial driver for the project was the observation that a common set of well-defined metrics were not readily available to the statistical programming community, and those that are used are often highly organisation-specific and are not published with clarity about how they are determined.

The range of tasks/metrics considered by the project focussed on those statistical programming tasks lying between two key common study milestones: final database lock and handing over the data to a regulatory department or similar ‘consuming’ group. Between these common milestones, the project focussed on identifying and developing KPIs in two major areas that require statistical programming input: the reporting of individual studies, and the integration (pooling) of data required for summary reporting and submissions (integrated summaries). A survey was designed to permit the reporting of the metrics categorised as “early” and “late phase”, to reflect the understood operational differences at these times over the clinical study life cycle.

This report presents the results of Year 1 of the KPI survey conducted on a small ‘sample’ of companies to test the acceptability of the KPIs and establish an initial benchmark set of metrics. The report was made available initially to those companies that completed the survey and now is available to download.

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