Top 5 Metrics Your Site Should be Using Today

Kerri Phillips
August 14th, 2013

There is a lot of discussion in the clinical research community about metrics. It is clear that sponsors and CROs are looking for data to support decisions regarding which sites  are the best partners. But, it is also true that sites benefit from collecting and tracking metrics as part of their own continuous improvement initiatives.

Which Metrics Should My Site Focus on First?

It can seem daunting to get started with a performance metrics initiative. But metrics are going to be an important differentiating factor as the landscape for sponsored clinical trials becomes increasingly more competitive. Once you start, it becomes easier over time to collect additional metric data and use the information to improve operations. To begin, here are the top 5 metrics your site should be measuring right now and what your site can learn from them.

Metric No. 1: Cycle Time from Draft Budget Received from Sponsor to Budget Finalized

Definition:

The time (measured in days) between the date that the first draft budget is received and the date that the sponsor sends approval of the budget.

What my Site can Learn from this Metric:

Sites that have short cycle times for this metric can use the information to demonstrate their responsiveness and professionalism to sponsors and CROs.

“This metric is helpful as a starting point,” said William Dirkes, MD, MBA, President and Chief Research Officer at Sentral Clinical Research Servies, LLC. “I would also track some additional steps between these dates, to get an accurate measure of how much time should be attributed to my site and how much to the sponsor.”

Dirkes points out that there are instances when the sponsor or site has more or less responsibility for the total time that certain steps take. “For instance, I had one contract that I reviewed and returned in 48 hours and then it took the sponsor two months to review it because it had to be approved in Germany,” he explained.

“This metric is helpful as a starting point,”

Long cycle times for this metric can signal your site to investigate further and identify areas where the process is being delayed. Such data can be used to start a conversation with the sponsor or CRO about finding ways to improve this process.

Learn more about how your research organization can improve your research operations strategies with actionable insights from Forte Insights.

Metric No. 2: Cycle Time from IRB Submit to IRB Approval

Definition:

The time (measured in days) between the date that the initial submission packet is sent to the IRB and the date that the protocol is approved or marked as exempt.

What my Site can Learn from this Metric:

If your site routinely approves new trials in a timely fashion, sponsor and CROs will take notice. IRB approval is one of the first milestones in the life cycle of a clinical trial and the variability between sites at this step is great. Use a good track record for this metric to your advantage when promoting your site’s abilities.

If your site is experiencing delays in IRB approval, you can use this metric to start a conversation with your IRB about finding ways to work together to improve the approval process.

It may be helpful to track additional steps for this metric, as well, suggests Kerry Bridges, MBA, RN, CCRC, Administrator at the Indiana University Simon Cancer Center. “It’s been presented that IRBs are blamed for a lot of delays when, in fact, if you track the metrics, it’s often the principal investigators, CROs, or sponsors who are slow in responding to queries,” said Bridges.

What about sites that use central IRB?

“It would probably be more meaningful for us to track the time from receipt of regulatory documents to IRB submission,” suggests Dirkes.

Metric No. 3 : Cycle Time from Contract Fully Executed to Open to Accrual

Definition:

The time (measured in days) between the date that all signatures—internal and sponsor—are complete and the date that subjects may be enrolled.

What my Site can Learn from this Metric:

Subject accrual is a significant challenge across the industry. If your site’s performance for this metric is good, be sure that you leverage this in negotiating with sponsors and CROs. Getting new protocols open to accrual faster means that your site has more time to enroll subjects. Sites with a history of good performance for this metric will be selected first for future trials.

As with other metrics, long cycle times here could indicate that your site should try to identify areas where the process is being delayed. Then, track this metric over time to verify that any changes have had a positive impact.

Metric No. 4: Volumetric – Number of Active Protocols

Definition:

The number of Protocols that are not in Long Term Follow Up with one of the following statuses: Open to Accrual, Closed to Accrual, or Suspended within a given month.

What my Site can Learn from this Metric:

An important measure of your clinical research operations capacity, this metric is key to evaluating other areas of your operations. In combination with other performance measurements, this metric is integral to determining operational efficiencies. Examples of combined metrics include the number of active protocols per clinical research coordinator or the rate of subject accrual per protocol.

Metric No. 5: Volumetric – Number of New Subject Accruals

Definition:

The number of subjects accrued during a given month.

What my Site can Learn from this Metric:

This is an important measure of your site’s ability to deliver on your accrual targets. Sites with a history of successfully meeting accrual targets get selected first for new trials. This metric in combination with other metrics, such as screen failures and expected enrollment rates, can also provide important feedback about the appropriateness of a given trial for your patient population. The ratio of new subject accruals to the total number of active protocols is a key indicator of your site’s enrollment success.

“In my experience, during site selection, CROs and sponsors ask for information related to how we have performed on similar studies to include the number of enrolled subjects versus what was  contracted,” said Anne Reedy, Research Manager at the MultiCare Health System Institute for Research & Innovation. “We’ve started to track this information more readily in our CTMS so we can quickly pull reports on our past performance during the site selection process.”

According to the Tufts Center for the Study of Drug Development, two-thirds of sites do not meet patient enrollment requirements of a given study. A site’s ability to successfully recruit patients will set it apart in an industry plagued by failed accrual targets.

“We’ve started to track this information more readily in our CTMS so we can quickly pull reports on our past performance during the site selection process.”

An example of how this metric was used to implement positive changes is given by the Winship Cancer Institute at Emory University. Research has shown that research studies that accrue the first patients slowly are less likely to be successfully completed due to inadequate overall accrual. Motivated by this data, Winship enhanced its closure policies in order to limit the time and effort wasted on trials that were unlikely to be successful. At the Onsemble 2010 Spring Conference in Chapel Hill, Ellen Graves Wojcik, MBA, CCRP from the Winship Cancer Institute at Emory University gave a presentation on the impact these closure policies. Changes implemented included stricter guidelines related to accrual, such as requiring new trials to reach at least 25% of their target accrual during the first six months or be subject to closure. After just one year, the Winship Cancer Institute was able to demonstrate positive and measurable changes in the performance of their trials.

This metric is also helpful for evaluating patient recruitment efforts. By tying accruals back to specific efforts, return on investment can be more easily calculated.

Next Steps

With these five metrics, your site will have powerful tools for your continuous improvement efforts and for winning more trials. Looking for more? Discover how Forte Insights can help you easily answer critical operational questions and gives an in-depth analysis of past performance, current state and projected outcomes. 

Learn more about Forte Insights

3 Comments

3 thoughts on “Top 5 Metrics Your Site Should be Using Today

  1. Metric 1 and 3 usually ends up being a measure of industry sponsor responsiveness and due process, more than anything meaningful from a site’s process perspective. Interestingly, CROs and sponsors employ this metric to measure and evaluate sites, and in doing so shed greater awareness to their own processes herein. Sites should keep track of this metric to measure and evaluate their sponsors and who to continue doing business with.

  2. Thank you for this information. It serves as a conscious check that I am on target with my Clinical Trial Metrics Programs.

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