In clinical research, there’s no question that faster activation timelines are in everyone’s best interest. The faster a clinical trial is activated, the sooner patients have access to treatment. The quicker a study is completed, science can continue advancing to make better treatments available to all.
From an institutional standpoint, faster study startup means increased site accrual and a competitive advantage in accruing participants. Perhaps most importantly, shortened activation timelines lead to greater site efficiencies. Fewer resources spent on activating each trial means more trials activated, and the benefits to both sites and participants continue to multiply.
With this in mind, it’s no surprise that the National Cancer Institute (NCI) sets high standards for protocol activation timelines. In their presentation at the 2019 Fall Onsemble Conference titled “Perspectives on Cancer Community Activation Timelines”, Sarah Stewart, Assistant Director of Clinical Research at the University of Wisconsin Carbone Cancer Center and Wendy Tate, PhD, GStat, Director of Analytics at Forte state that the NCI expects protocols to be activated in 8-12 weeks.
However, as they go on to discuss, despite the advantages of shorter activation timelines, these expectations are not being met by virtually all cancer centers. This begs the question: Are the NCI’s expectations achievable?
Using Forte’s Benchmarks comparative analytics platform, Stewart and Tate discovered the majority of treatment protocols take over six months to activate, or nearly double the high end of the NCI’s expectation. Additionally, two-thirds of cancer centers have fewer than 10% of protocols activating in less than 12 weeks. When considering median activation times, only two organizations analyzed had a median activation time of under 120 days, which still falls roughly 50% higher than the NCI expectation.
Why are NCI expectations not met across the board? Perhaps more importantly, what can be done to improve study startup time? Stewart and Tate offered ideas on both questions.
When it comes to slow activation cycles, oftentimes overextended staff and duplicate or sequential processes slow down the process. Sometimes, investigators or other staff simply “sit” on their duties for too long, whether it’s signatures or reviews, potentially holding up the entire process. However, on a larger scale, there may not be enough objective data to truly anticipate realistic guidelines. Making the NCI aware of the state of activation times in the cancer community is the first step to setting achievable goals. But the next step needs to be improving start up time.
Stewart and Tate, along with session attendees, shared their ideas for getting studies up and running faster, including running concurrent processes, such as PRMC and IRB. They also suggested trying to minimize gap time between the finalization of the last major activation process and officially opening the study to accrual. Finally, they discussed having dedicated activation staff to manage workload and the number of trials in activation.
While there is no easy answer, opening up the discussion about where the cancer community is currently in terms of activation and where they need to be is an important step in the right direction. By sharing best practices and ideas for overcoming challenges with one another, the Onsemble Community continues to push forward together.
Forte’s Director of Analytics Wendy Tate identifies key data trends that are impacting cancer centers today in the “Cancer Center Benchmarks Report.”
This report analyzes aggregate data from over 20 cancer centers nationwide including trends like the number of trials being opened year over year, the amount of sponsor funding and the rate of study enrollment.