Site-Driven Metrics: Using Operational Data to Improve Clinical Trials

Kristina Lopienski
September 11th, 2018

Many CROs and sponsors collect metrics on site performance for their own use, often requiring sites to provide much of the information using a variety of tools and formats. However, many of these efforts are of little value to sites because the metrics don’t truly capture the operational realities of conducting clinical trials. The metrics collected and the methods by which they are collected are determined with a top-down perspective of what the sponsors and the CROs want, rather than the sites.

For some sites, metrics are synonymous with the mandated collection of seemingly arbitrary data for reporting to sponsors and CROs. Yet, the true value of metrics is to measure operational performance in order to improve internal processes. In clinical research, this can be highly beneficial when applied where the work is being conducted—at the sites.

The need to go beyond sponsor-driven metrics

Most metrics initiatives are geared toward sponsors and CROs, with inconsistency among organizations. What’s important and worth tracking for a sponsor is going to be different from what the site finds valuable. Of course, some site and sponsor metrics are similar, but others may set benchmarks and measure two completely separate aspects of the same process. By looking exclusively at the site perspective with their needs in the forefront, real improvements can be made based on their own workflows and associated operational data.

The ultimate use of metrics is to bring data into conversations to inform one another and create an efficient, effective partnership that will work well in the long-term. This doesn’t mean a one-sided dynamic but rather having sites be their own advocates. Focusing on what’s happening at the sites can uncover ground-level realities. After all, sites can collect more data than sponsors/CROs about their own performance, including those that may reveal delays involving the sponsor or CRO or those that are more useful for internal purposes. With a thorough understanding of the complexity of site processes, it’s also critical to make tracking metrics as easy as possible for sites by leveraging the data they have on hand.

Examples of Site-Driven Clinical Data Management Metrics

Our infographic, Top Clinical Research Metrics for 5 Critical Questions, outlines questions your study site should ask, along with metrics the questions cover.

The metrics these questions go over include:

  • Accrual to date vs. target enrollment
  • IRB submission to approval
  • Diversity of participant over time
  • Days since last participant enrolled
  • Staff time spent on protocol per task

Effective analytics strategy built at your research organization has the ability to greatly impact your research operations, enhancing overall trial performance. They also help to avoid common roadblocks by taking crucial steps to set up your strategy.

Collecting data directly from the site’s source of truth

Research sites will have the most success with metrics if they focus on data already within their grasp and recorded as part of their daily and natural workflow. For sites that have implemented a clinical trial management system (CTMS), this comes right from their operations data rather than surveys or manual entry into various sponsor and CRO systems.

A site CTMS makes the collection of metrics automatic. For example, measuring the time it takes a site to open a study is easy when the site uses a CTMS to administer their portfolio of clinical trials. With a system in place, the site just needs to count the days between the date the protocol is sent for IRB review and the date the first patient is enrolled—these dates are already recorded within the CTMS. This approach not only ensures the metrics collected are meaningful, but also an accurate representation of how the site performed in the past.

Utilizing actual operational data directly from the source, as opposed to each site submitting their own aggregate metrics, ensures data consistency for reporting analysis. Sites can easily retrieve and export this data and create snapshots of their performance to share with sponsors/CROs. This improves study conduct at the sites and results in more timely data for the sponsor and CRO.

How multiple stakeholders benefit from site-based metrics

Sites can give the sponsor some sense of their internal progress and projected timelines for completion. With visibility into a set of key milestones for the current trial, and the site’s performance data from past trials for cycle times between these key milestones, it becomes much easier to predict when to expect certain activities to be completed (e.g., to receive the signed contract). Efficiencies are gained by increased transparency and eliminating the back and forth of repetitive phone calls.

Sites also reap the rewards of collecting metrics that reflect their business goals and daily operations to improve internal processes. By objectively measuring their performance, sites can better identify and target areas of weaknesses, as well as use metrics to promote their strengths. This self-awareness helps a site’s ability to select trials on which they will be successful, and ultimately prevent wasting both their time and the sponsor’s.

[Related eBook: Improving Site-Sponsor Relationships: Proactive Strategies for Transparent Clinical Trials]

When sites bring data-driven rationale into conversations with leadership and sponsors, their requests are more likely to be understood and granted. Sponsors and CROs benefit when sites proactively promote their strong areas when being considered for study opportunities and have past performance data as an indication of future performance. The ability to complete site feasibility questionnaires with real data saves time for everyone and leads to more accurate expectations. Sponsors and CROs also build partnerships with sites that are motivated to collect the desired data for measuring and improving clinical trial operations.

Some predictors of site success from the sponsor/CRO perspective that sites can support with their own metrics include:

  • Past performance: Tracking site performance over time and comparing performance to aggregate industry values.
  • Experience: Demonstrating experience and success using volumetrics such as the number of trials conducted, as well as cycle-time metrics.
  • Investigative site focus: Using performance metrics to identify areas for continuous improvement and strengthen the site’s clinical research infrastructure.
  • Historic speed to randomize the first study volunteer: Evaluating cycle time metrics to identify opportunities to improve processes and cycle times, including the time to get a trial to Open to Accrual status.

While metrics have long been associated with site-sponsor relationships, the use of metrics among sites to improve internal processes and strengthen relationships with sponsors is gaining traction. Site-centric performance metrics can be implemented using tools that are already part of the site’s daily workflow to provide demonstrable results in a relatively short timeframe. These metrics can also show greater efficacy than the top-down approach currently employed by many sponsors and CROs. Using these tools to track site-centric metrics takes less effort to collect, is more actionable, and better motivates the right behaviors. An industry full of self-aware sites results in improved clinical research operations and a rich pool of metrics from which to draw.

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