Top Clinical Research Metrics for 5 Critical Questions
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Top Clinical Research Metrics for 5 Critical Questions
There are many benefits to operational performance metrics. Tracking your research program’s operational performance allows you to:
- Monitor progress of open studies
- Use data to inform process decisions and changes
- Assess performance trends over time
- Streamline communication between all stakeholders
- Identify processes and steps in need of improvement
- Answer strategic operational questions
The following are metrics to answer five critical questions:
1 ) Which of my studies are failing to achieve enrollment targets?
Why is this critical? If you aren’t enrolling participants, you’re losing money, wasting valuable staff time, and increasing staff turnover. How can metrics help? Performance metrics allow you to monitor accrual, course correct to avoid a major loss, and assess enrollment feasibility.
The top metrics to help answer this question are:
- Accrual-to-date versus target amount
- Days since last participant enrolled
2) Which studies are currently in the process of study startup and how are they progressing towards activation?
Why is this critical? Delays in study activation leads to gaps in trial processes, lost revenue, and fewer studies from sponsors. How can metrics help? Performance metrics allows you to:
- Identify commonly delayed steps
- Pinpoint cause of problem
- Estimate more feasible timelines
- Reduce time to activation
- Track billable time during study activation
The top metrics to help answer this question are:
- Contract receipt to execution turnaround
- Institutional review board (IRB) submission to approval
3) Am I getting a representative sampling of my catchment area?
Why is this critical? Research organizations are responsible (and required) to have a representative sampling of trial participants by location, gender, race, and ethnic status. How can metrics help? Performance metrics confirms the research conducted is diverse, effectively serves your community, and helps fulfill National Institutes of Health (NIH) grant funding reporting requirements.
The top metrics to help answer this question are:
- Participant ethnic status by protocol
- Diversity of participants over time
4) How much staff time (effort) is going into activating a new study?
Why is this critical? Too often, sites are not reimbursed for all study-related time and effort, incur non-refunded costs for pre-screening and oversight, ultimately losing valuable time and money. How can metrics help? Effort tracking makes sure you’re reimbursed for all study-related efforts, can objectively negotiate study budgets, and effectively allocate resources for future studies.
The top metrics to help answer this question are:
- Staff time spent on protocol per task
- Individual staff time spent on activation tasks per protocol
5) How has accrual within a specific department performed over time?
Why is this critical? At the leadership level, you need to manage the performance of different departments, oversee progress towards organizational goals, and ensure departments are equipped for unique needs. How can metrics help? Performance metrics allow you to compare performance between groups, see how the research portfolio has grown over grant periods and confirm grant funding is used effectively.
The top metrics to help answer this question are:
- Percent accrual per department
- Time to activation per department
Building an effective analytics strategy at your research organization leads to strong impacts in your research operations, improving overall trial performance. However, it’s critical to take the necessary steps to set up your strategy for success and avoid common hurdles.