In CPU, Phase 1 Clinical Trials

Are Staff Properly Optimized at Your Clinical Phase 1 Units?

Optimizing Staff at Clinical Phase 1 Units

When it comes time to selecting clinical phase 1 units for a large study, there are a number of items, both basic and advanced, to consider when making a decision. One such advanced criteria which we felt warranted further explanation was whether or not staff were properly optimized for efficient performance during Phase 1 studies. An optimized group of study personnel can be the difference between successful clinical conduct or a study which opens up the possibility of high costs and high risks to Sponsor companies.

While it may not be the easiest or most exciting exercise for a Phase 1 site to take, we believe that it is one of the most beneficial in terms of the site being able to provide value to Sponsor companies and their CRO partners. Furthermore, undergoing this type of internal evaluation can reduce risks throughout study conduct, providing a safer environment for volunteers. In our experience conducting Phase 1 studies, we found that these three strategies can drastically improve the overall efficiency and performance of staff at clinical Phase 1 units.

3 Strategies for Optimization:

1. Take time to assess clinical procedures in detail.
Whether performing standard procedures or more complex ones, it would benefit every site to know exactly how much time is needed to perform the procedure (in the safest and most efficient manner possible under protocol guidelines) as well as the level of experience needed by personnel to perform the task.

By determining the level of experience which is needed, sites can determine what kind of staff to assign to the task. Is an investigator needed to perform the task, or will a nurse or laboratory tech suffice? By determining these two key pieces of information, Phase 1 sites will be able to more accurately price their services and provide better value to their clients.

2. Analyze historical data.
While no two protocols are exactly alike, there are bound to be similarities in study design, required procedures, timepoints, and administration routes between multiple protocols. Clinical phase 1 units should take some time to convene with key staff and project managers from previous studies and evaluate the overall performance and staffing needs from those studies. Was the unit understaffed during a certain procedure or timepoint? Or did it overestimate the number of staff needed to appropriately carry out the task? In both situations, sites can potentially put volunteers at risk by either having too few staff to perform the procedure safely, or a congested floor which can cause confusion and errors.

By ensuring that there is no over or under-utilization of staff, sites can ensure that their clients are only paying for the exact staff needed for any given protocol, and that the site has a better understanding of their overall personnel needs from day to day.

3. Conduct an in-depth protocol analysis.
The unfortunate truth is that when evaluating a protocol and determining costs of services provided, most sites will apply blanket assumptions, not considering how different types of studies will require different levels of resourcing. Here are some questions which study teams can ask themselves when evaluating a protocol:

How many cohorts are needed to efficiently run the study?
What equipment will be necessary to complete the study?
Based on the necessary equipment for this study, how are personnel requirements affected?
Will these procedures require a full-time, dedicated team, or will staff be able to work on other projects taking place concurrently?

By asking these and other study-specific questions, Phase 1 sites can more accurately determine the staff required to successfully conduct any given study.

By implementing these three strategies, clinical Phase 1 units will be able to ensure that they are not only providing the most efficient approach to conducting a clinical program, but the safest, best-staffed, and most cost-effective approach as well.


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