Taking the Guesswork Out of Workload Planning for Your Clinical Trials

Kristina Lopienski
March 13th, 2018

It can be difficult to know whether or not your site has the bandwidth to give a protocol justice before you’re already far along in the process. Yet, sites must determine who is needed for the study and make sure they will be flexible enough to provide continuity throughout the trial and any possible delays.

Tracking staff effort helps your site set and meet expectations, from aiding in contracting and budgeting to maximizing staff productivity. It helps you understand how many trials your site can handle, how to allocate staff and where staff should focus their time.

To help sites make the change from speculation and guesswork to confidently relying on effort data, we share a few tips to help you better understand how staff time is being spent.

[Related eBook: How to Conduct Valuable Effort Tracking at Your Site]

Ensuring staff are tracking time

Before you can gain meaningful data from the hours your staff are logging, it’s important to make sure staff are indeed tracking their effort. Getting in the habit of consistently tracking time can take a while, but accuracy is key to generating reliable data.

You can use a period of time to calculate the appropriate number of hours compared to a 40-hour work week to see which staff are not reporting the full volume of hours as you would expect (e.g., if a coordinator logged 20 hours of time in a week when they work 40-hour weeks). Additionally, you can see if people are recording far greater than the full anticipated effort and determine if everything is okay.

You can follow up with staff who haven’t tracked their time or are way outside of a typical window. You may realize you need to send reminders to get people used to recording their time, or even dedicate more resources to reduce the workload of certain staff.

Knowing how much effort it takes to accrue patients

The number of hours of effort per accrual can vary greatly across management groups, therapeutic areas and more. Understanding which protocols are wasting time or have a higher than desired amount of effort with not enough accrual results can help you decide if the protocol should be closed or if more resources need to be added.

For example, two studies have an enrollment target of 20 accruals each. Study A has hit 75% of its accrual goal in 100 hours, and Study B has achieved 10% of its goal in 100 hours. If it took Study B that long to get their first couple of patients enrolled, how long will the next 18 take? For Study B to meet its anticipated completion date for enrollment, the site must intervene to help it get there.

Determining how much effort it will take to activate new studies

Once you have been tracking staff effort long enough, you will be able to use past data to help project future outcomes. One area for which this is very helpful is study activation. Anticipating how much time it will take to activate a particular study by identifying similar protocols that have finished the activation process allows for better planning and resource allocation for a timely activation.

Using this information, you can also ensure the budget covers effort put forth in activation. You can provide this data to the sponsor as justification for charging more, since you can prove it takes this much time (even comparing your history with this sponsor to other sponsors).

Additionally, you can bring this data into conversations with PIs who may believe they can open three new studies because they just closed three studies. However, looking at how much effort it took in the past may help set realistic goals and prevent delays or a lack of resources in the future.

[Related article: Speeding Up Study Activation: How to Spot Bottlenecks]

Tracking staff effort provides many benefits to sites, from optimizing workloads to aiding in budget justifications. Ultimately, tracking staff effort pays off. The longer you track time, the more value you will gain and you’ll be able to use the data to help predict future timelines and outcomes.

With Forte Insights, sites that use OnCore as their CTMS can assess how effectively staff time is spent. Forte Insights helps immediately identify protocols that take the most effort and accrue the least patients, view consistency of staff effort tracked over time, and determine resources needed to activate a study.

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