Beginner’s Guide to Clinical Trial Performance Metrics

There is a lot of buzz about metrics in clinical research and the need for sites to use them. But what exactly are metrics? And why should sites get excited and involved? If you are new to metrics, these are important questions to understand. Here, we answer those questions and provide tips for how to start measuring and using metrics to improve your organizations operational performance.

What are clinical trial performance metrics?

Clinical trial performance metrics (also commonly referred to as operational metrics, or key performance indicators) are data points that provide insight into operational performance. The use of metrics is two-fold: improving processes internally and strengthening relationships with sponsors.

While metrics have long been associated with site/sponsor relationships, the use of metrics among sites to improve internal processes is gaining traction.

Why should your site measure performance?

As noted above, sites can gain enormous benefit in terms of internally improving operations and working with sponsors.

Benefits for internal operations include:

• Identifying where process improvements can be made
• Identifying where resource allocations can be changed
• Effectively managing workload across teams
• Establishing performance benchmarks
• Providing data-driven rationale to leadership for additional resources

The benefits from the sponsor relationship perspective include:

• Identifying areas of strong competitive advantage
• Ability to complete site feasibility questionnaires with real data

Which key metrics should your site track?

There are many options when it comes to measuring operational performance. So where should your site begin? Specific metrics that could assist your site with internal processes and sponsor relationships include:

1) Cycle Time from Draft Budget Received from Sponsor to Budget Finalized:

The time (typically measured in days) between the date the first draft budget is received and the date the sponsor approves the budget.

What your site can learn: 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.

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

2) Cycle Time from IRB Submit to IRB Approval:

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

What your site can learn: 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.

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.

3) Cycle Time from Contract Fully Executed to Open to Enrollment:

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

What your site can learn: Subject accrual is a significant challenge across the industry. As with other metrics, long cycle times here could indicate your site should identify areas where the process is delayed. Then, track this metric over time to verify any changes with a positive impact.

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

How to realize success

If you can measure it, you can improve it. Knowing the numbers/results from the metrics above can help you identify weaknesses and serve as a comparison over time for trend data as well as measure progress made. Tracking metrics over time is something to build into your process and the benefits of doing this are well worth the effort.

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