National Cancer Institute
National Cancer Institute U.S. National Institutes of Health

Evaluation Plan

The CTWG report (PDF - 366KB) included recommendations for a quantitative and qualitative, evidence-based evaluation plan to assess measures of program management process, system performance process, and system outcomes. The evaluation plan consists of:

  • a baseline feasibility analysis,
  • interim evaluations of specific initiatives related to these measures,
  • and final evaluations at specified intervals after implementation of the initiatives.

The evaluation is intended to compare the baseline to the future based on system outcome measures (overall output) and system performance measures (performance of individual CTWG initiatives). The system outcome measures gauge the quality and impact of trials and the efficiency of both trial development and initiation and trial conduct.

The determination of success or failure and decisions on any needed course corrections will be a matter of judgment by experts in the field, informed by systematic, structured empirical data so that there will be a shared basis for discussion and decision making.

NCI has engaged experienced evaluation specialists to assist in development of the definitions, survey instruments, statistical adjustments, and other tools required for the evaluation measures to be practical and valid and to conduct the evaluations. These specialists will also determine the appropriate timing for examining the various measures in the context of implementation timelines and the nature of the impacts envisioned.

A baseline evaluation of the current system was completed in 2008 to provide a reliable basis for ascertaining the value of the restructuring effort. The results of this baseline evaluation will be analyzed by a Working Group of the Clinical Trials and Translational Research Advisory Committee (CTAC).? The Working Group members will propose which elements of the recommended evaluation system should be implemented and establish a timeline for follow-up evaluations.

CTWG Evaluation Plan, Results of Baseline Feasibility Analysis (PDF)
Presentation to NCAB, February 6, 2008, Dr. James Doroshow, Chair, CTWG