In CPU, CRO, Phase 1 Clinical Trial

Clinical Research Blog Series: Reducing Start-Up Time in Early Clinical Development—Functional and Flexible Staffing

In many cases, Sponsors hope to breeze through the early clinical development phase of their asset’s lifecycle, and thus, the ability to expedite a Phase 1 trial as much as possible is a critical factor when assessing potential study sites. In this clinical research blog, we will highlight some traits that Sponsors can look for at study sites which are likely to optimize the time needed for Study Start-up. One such characteristic is a site that maintains both functional and flexible staff to perform tasks related to IRB submissions.

Streamline IRB Submissions via Flexible, Functional Staffing

In Phase 1 trials, there are a plethora of documents that need to be created and submitted to the IRB for the study to be approved, which can take several weeks to complete (and several more to receive approvals). However, this process can be streamlined by using a combination of functional and flexible staff to perform the various sub-tasks associated with IRB submissions.

For example, instead of assigning a single study coordinator to handle all aspects of the Start-Up phase, including document creation, submissions, and creating a plan for study conduct, we encourage that the various activities be overseen by a team comprised of personnel from various functional areas. Your team might include an individual staff member that is responsible for each of the following tasks:

  • Source Document creation
  • Drafting Informed Consent Forms
  • Creating subject-facing materials such as phone scripts and reminder cards
  • Managing translations
  • Creating study advertising materials

By spreading out the tasks associated with start-up to various staff, the overall timeframe to complete these tasks can be reduced, as illustrated in the below graphics:

 

Single Staff Model

Reducing Start-Up Time in Early Clinical Development-Single Staff Model 

 

 

 Functional Staff Model

Reducing Start-Up Time in Early Clinical Development—Functional and Flexible Staffing

Furthermore, we encourage that staff be structured in such a way that urgent requests can be responded to based on need, rather than by the position in a queue. While following a process comes with its benefits, it can be detrimental if a facility’s staff are beholden to a process that would not allow their time to be re-allocated or pivoted to handle more pressing tasks.

In early clinical development, where many factors are by nature uncertain due to limited clinical experience with the drug, this flexibility can be a crucial factor in responding to unanticipated issues that may come up during the process.

 

We encourage you to watch out for the next article in this clinical research blog series, which will discuss the benefits of utilizing a pre-screening strategy in Phase 1 trials.

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