Returning to In-person Work: Sponsor Versus Site Viewpoints

As March 2020 completely disrupted any sense of normalcy, including in the workplace, many were forced to adapt rather quickly. As we begin to enter into a “next normal”, we surveyed the industry to get their take on what they think the industry will look like moving forward. The report includes analysis from those at sponsor organizations and sites alike, and this blog focuses on important shifts we will see industry-wide as we continue to navigate the pandemic: staffing, budgeting, and time allocation.

Shifts in Staffing Across the Industry

Survey results found 48% of respondents indicated research staffing will change at their organization – 73% of those respondents anticipated research staffing would worsen over the next 12 months at their organization. While that may indicate people are leaving the industry altogether, we’re seeing a shift in staff leaving sites and moving over into the sponsor realm. What are some contributing factors to this shift?

In order to understand future trends, we must understand how we got to this point. When the pandemic set in around March 2020, and regular research operations weren’t able to continue for the foreseeable future, many clinical research sites experienced furloughs or layoffs. As staff were laid off, many moved into other forms of the industry instead of exiting it altogether.

This shift caused a wide influx of staff coming into sponsor organizations, and many are staying even as research operations resume. Currently, sponsors are providing a more flexible work style for most, including remote modalities, and allowing staff to work from home instead of coming into an office.

With this in mind, sites will need to rethink how to navigate a research study if the staff shortage continues. Sites will need to consider how they can work with sponsor organizations and contract research organizations (CROs) on what parts of their clinical trials they can outsource, such as to a home health care organization. This can minimize the need for in-house staffing due to staff shortages.

Resuming On-site Activities

As research continues to open back up and activities resume, there are still differences in what in-office work looks like now versus early 2020. For research sites, operations look different in every organization, and many coordinators are still facing restrictions, especially in clinics with higher-risk patients or in locations still facing high COVID-19 infection rates. It’s important to remember we are still in a pandemic state, and most organizations are still adapting to rapidly changing situations.

Shifts in Budgeting and Time Allocation

Since the industry is seeing a shift in staffing, many sponsors are noticing sites are having a hard time staffing sites for various tasks, such as database logs, training, monitoring, and more. Because of this, it affects the sponsor’s timeline across the board, and they must make updates to accommodate, including extending timelines. This also impacts study startup timelines, as clinical trial agreements (CTAs) and budget approvals take longer. Study conduct time increases due to minimal staff having the time to recruit and screen study participants, perform data entry, and have monitoring visit availability.

Adjusting a trial’s timeline ultimately costs sites and sponsors money as well, affecting budgets and money allocations. A notable area where budgets are expanding is in the realm of remote monitoring. At the site level, it’s costing more for sponsors to monitor trials remotely. Instead of a study coordinator being available at set times and intermittently throughout the day, they need to be available for the entire day. They also must make additional system access requests and privileges for the various systems a sponsor monitor needs to review. This requires giving site personnel time to complete the tasks as well as procedures to ensure privacy and access rules compliance.

Key Takeaways for Sponsors and Sites

While remote monitoring can benefit sites and sponsors in the long run, they are currently costing about twice as much since personnel are taking twice as long to complete tasks. This also drains the staff because it’s taking time away from them for tasks they also need to get done or could do instead of tending to remote monitoring needs. Over time, however, we anticipate timelines and budgets will tighten up as staff continue to adapt to remote modalities.

Special thank you to Wendy Tate and Adam Ruskin for providing insight into this blog.

To learn more about how the COVID-19 pandemic impacted the future of the clinical research workforce, read our trend report.

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