Related Articles
1. Monitoring the Monitors
2. Investigator Site Audit Performance
3. Measures of Success
(Photography: Getty Images Illustration: Paul A. Belci)
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Project Phidisa is a clinical research project focused on the management and treatment of HIV infection in the uniformed members
of the South African National Defence Force (SANDF) and their dependents. This is a joint research collaboration between the
SANDF, the United States Department of Defense, the United States Department of Health and Human Services, the National Institutes
of Health, and the National Institute of Allergy and Infectious Diseases. The project currently encompasses an epidemiology
study for HIV positive or negative individuals and a treatment protocol for individuals infected with AIDS.
In accordance with the Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa,1 clinical research monitors are appointed by the trial sponsor to perform quality assurance activities related to the conduct
of the trial. As such, any noncompliance with the protocol, standard operating procedures (SOPs) or applicable regulations
should be communicated to the study team and remedied immediately. The sponsor is obligated to terminate the participation
of an investigator and/or site if persistent noncompliance is noted.
Table 1. Parameters are measured against a target standard.
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To evaluate site compliance, a matrix of performance measures (benchmarks) was established for Project Phidisa in July 2005.
These benchmarks are a tool for members of the Phidisa Project to prioritize and review the outcomes of the current compliance
assessments and to evaluate any interventions that were implemented to decrease noncompliance. Evaluating clinical site performance
based on the benchmark tool has had many benefits, though limitations of the tool have also been realized.
Tools of the trade
Benchmarking has become a popular mechanism in the business community to increase performance by evaluating internal practices
and measuring them against standards set as performance metrics. Business executives have realized the benefits of a metrics-based
approach to evaluate the performance of operations in order to maximize productivity. Performance metrics provide a numerical
standard against which critical values can be compared. Over the past several years, this tool has been adopted by the clinical
research industry with the goal of maximizing site performance.
Although only a few articles have been published on this topic, much of the literature that exists focuses on laboratory selection,2 site selection, and site maintenance. Several clinical research organizations (CROs) have used this tool to allocate site
payments, as they are determined by evaluation of performance metrics.
One research study outlined the use of benchmarking clinical trials in Central and Eastern Europe.3 This research evaluated site benchmarking analyses as related to speed (number of days to obtain review approvals to the
first subject visit), quantity (number of subjects a site can enroll), and quality (number of queries per case report form
[CRF]). The study concluded that benchmarking provided an effective tool for improving data quality, reducing time to market,
and realizing a decline in development costs.
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