The ACTG has an established, comprehensive, and data-driven performance evaluation program (PDF - 290 KB) to promote high quality research within its multi-center clinical trial network. The Performance Evaluation Committee (PEC), which has oversight of the program, develops and implements effective methods to measure performance at sites and laboratories as well as across other key components of the network.
Drawing insight and expertise from a membership that is representative of the network as a whole, the PEC develops meaningful performance measures that focus on study integrity, scientific quality, efficient resource use, and the protection of research participants. Major areas assessed by the program include enrollment, retention, data management, and regulatory and protocol compliance. Performance standards are established based on the median of the group performance in order to mitigate the influence of local geographic, cultural, and economic variances.
Performance is monitored through a continuous cycle of monthly data reviews and formal interim and annual evaluations. This ongoing review process promotes early problem detection, motivates improvement and advances the practices necessary to ensure clinical research sites and laboratories meet the network’s expectations for high-quality performance.
Based on in-depth analysis of cumulative performance data, the PEC reports to the network leadership on the network performance overall and makes specific, practical recommendations concerning the performance of individual sites and laboratories. The leadership, in consult with DAIDS formulates final decisions concerning modifications and possibly sanctions that may be needed to ensure that each site and laboratory contributes at an acceptable level to the overall strength of the network. Evaluation findings and the resulting decisions are communicated to the sites and laboratories in formal, individualized reports that detail performance data in each area subject to assessment.