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The clinical trials industry can benefit from site-driven metrics for process improvement and site scoring.
The last decade has been marked by an increased desire among sponsors and CROs to measure and track performance related to study conduct at all stages of the clinical trial lifecycle. Motivated to implement continuous improvement strategies for better efficiency and quality, sponsors and CROs have collected a growing amount of data and metrics related to operational performance.
Metrics can be powerful tools for implementing data-driven process improvements. One organization in particular, the Metrics Champion Consortium (MCC), is actively encouraging their use within the clinical trial industry. The MCC is a nonprofit dedicated to the development and support of performance metrics and quality tools within the clinical trial industry. The MCC encourages sponsors and CROs to reduce cost and improve the success of their trials by investing their resources in doing things right at the beginning of a study-approving well-designed protocols and selecting sites that can enroll qualified patients and execute the protocols, rather than having to fix the protocols and add sites to the studies part way through the trial.1
While this focus on data-driven process improvement is good, there is still much left to be desired from the point of view of the sponsors and CROs. For one thing, sponsors and CROs are often frustrated by the time lag inherent in the process of collecting operational data and the lack of insight into study conduct between monitoring visits.
According to data collected by the Tufts Center for the Study of Drug Development, about 90% of all clinical trials are delayed due to over-ambitious timelines and difficulty enrolling patients. Further, for the average trial, about 20% of all principal investigators (PIs) fail to enroll a single patient and 30% under enroll in a given trial.2 The cost of performance like this to the entire industry in terms of time, resources, and productivity is unsustainable. The opportunities to implement performance metrics in order to support continuous improvement strategies at the site level remain numerous.
Currently, many CROs and sponsors collect metrics around site performance for their own use, often requiring the sites to provide much of the information being collected, using a variety of tools and formats. However, many of these efforts are of little value because the metrics don't truly capture the operational realities of conducting clinical trials. The reason for this disconnect is that the metrics being collected, and the methods by which they are collected, are determined with a top-down perspective of what the sponsors and the CROs want and have little benefit for the sites.
Fortunately, the solution requires a relatively small shift in perspective. A shift away from requiring sites to enter seemingly arbitrary operational data into myriad sponsor and CRO systems and instead motivating sites to collect their own metrics for the purpose of measuring and improving their internal processes will not only improve study conduct at the sites but result in more complete and timely data for the sponsor and CROs.
Support metrics collection
The first step in collecting good operational metrics across all sites is for each site to implement a centralized database of its own. Sites that have implemented a clinical trial management system, or CTMS, that helps organize daily tasks and minimize manual processes for site staff, achieve good compliance with regard to data entry because the use of the CTMS has immediate benefits for individual staff members.
Once in place, a site-centric CTMS makes the collection of measurable performance data a natural part of the daily workflow for site staff because it happens automatically. For example, measuring the time it takes a site to open a trial is easy when the site is using a system like the Allegro CTMS@Site system to administer their portfolio of clinical trials. With this in place, the site just needs to count the days between the date that the protocol is sent for IRB review and the date that the first patient is enrolled-dates that are already recorded within the CTMS.
Sites benefit from collecting operational metrics by gaining self-awareness into areas for process improvement and better control of clinical trial financials. An often overlooked side benefit of good site metrics is the ability to focus on areas of strength. For example, in today's environment where only 30% of PIs deliver on their recruitment targets, sites can ensure they stand out by taking on studies that they know match their patient accrual capabilities.
Combine a solid understanding of its current operational performance along with a centralized database of its patients and volunteers, and a site's ability to select trials on which they will be successful is greatly improved. Sponsors and CROs benefit when these sites proactively promote their areas of strength when vying for study opportunities.
A site-centric method for collecting performance metrics combined with a CTMS can also greatly improve the time lag in the data collection process. Data that are collected as part of every completed task into a central repository are much easier to retrieve for reporting purposes between monitoring visits.
By nurturing an appreciation for data-driven process and quality improvement at the site level, players at all levels of the clinical trial industry benefit. At the sites, where the work is being conducted, sites benefit from the self-awareness of strengths and weaknesses, gaining tools for promoting themselves and making informed choices about which studies to pursue. CROs and sponsors gain partners in the sites who are motivated to collect the desired data for measuring and improving clinical trial operations.
Laura Youngquist, is Director, Allegro Product Management, Forte Research Systems, Inc., www.forteresearch.com/.
1. L. B. Sullivan, "Defining 'Quality That Matters' in Clinical Trial Study Startup Activities," The Monitor, 22-26, December 2011.
2. K. A. Getz, "State of the Clinical Trials Industry," keynote presentation at the 2011 Spring Onsemble Conference, Las Vegas, NV, March 23-25, 2011.
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