Over the last few years, and without much fanfare, the Office of Clinical Research (OCR) has been diligently overhauling how Fox Chase Cancer Center initiates clinical trials and gets them running. They formed the Study Activation Unit (SAU), tasked with smashing through the walls that siloed different processes across the cancer center. Their success can be measured in time—from 2021 to 2023, the median time to new study activation dropped by a stunning 182 days, landing below their targeted goal of 90 days.
“Clinical research drives medical science, and it is a leading reason why patients, clinicians, and scientists alike see Fox Chase as a leader in cancer medicine,” said Teena Kochukoshy, MD, MS, Associate Vice President of the OCR. “The Study Activation Unit and the Study Statusboard took a scalpel to some intractable problems and wove together a solution that allows us to deliver advanced care to our patients even faster.”
This past June, members of the OCR presented two parts of their success story during a poster session at the annual Clinical Research Innovation meeting of the Association of American Cancer Institutes (AACI). One poster presented an overview of the SAU’s approach, while the other described the Statusboard, a vital tool in the organization’s success.
Achieving Alignment for Activation
Karen Van Arsdale, a research project manager, and Michael Oldfield, JD, MBA, CCRP, the senior project manager in the SAU, presented the poster “New Study Activation: A Centralized, Desegregated Model (i.e., Getting our Ducks in a Row)” at the conference. The poster highlighted Fox Chase’s overall approach to streamlining the bureaucratic processes that inadvertently slow the start of new clinical trials. The SAU initiative came about during the lead-up to the resubmission of the Cancer Center Support Grant, or core grant, the National Cancer Institute funding mechanism that enables Fox Chase to call itself an NCI-Designated Comprehensive Cancer Center.
“The core grant was the major impetus to forming the SAU, as we were examining the cancer center’s overall approach to clinical operations and recruiting patients,” explained Oldfield. “We realized that there was a lot we could do, from a regulatory management standpoint, to shorten the time it takes to open new clinical trials.”
Oldfield and his colleagues identified that the increasingly complex regulatory ecosystem, combined with compartmentalized workflows and a lack of interdepartmental communication, was dragging Fox Chase’s best efforts to expediate the start of new clinical studies.
As Oldfield describes it, their approach was to build the SAU as a dedicated unit that could critically examine how the new study approval process flows across many different departments scattered across the institute. They began to meet weekly to track studies and hunt for roadblocks in real time.
“Word got out about what we were trying to do, and soon we would have leaders from across Fox Chase—people like Dr. Chernoff, Dr. Edelman, and Jarred Matchett—poking their head in to keep an eye on our progress and, more often than not, connect us to someone on their team that could offer support,” Oldfield said. “Every week, we would meet to figure out a new aspect of the problem and, incrementally, every week, we would move the process forward in some small way.”
By November of 2021, the SAU had a firm plan and began re-organizing new submissions. Fox Chase invested in their early success by funding the recruitment of additional staff, allowing the SAU to bring their reforms online by 2022. “We saw a number of drastic changes right away, and we committed ourselves to continue streamlining as we go,” Oldfield said.
The art of orderliness is near to the heart of Van Arsdale, who helped lead the team in coordinating data between the major streams of information involved in each new trial activation: committee submission, clinical operations, budgets, and contracts.
“I think one of the secrets to our success was really just using the data and communication tools that we have been given,” said Van Arsdale. “At the heart of many of our problems was an entire stew of information that we had to analyze to make sense, and we tapped into the functionality behind some of the tools we take for granted in the workplace.”
As Van Arsdale says, there are many separate parts of the cancer center involved in making a successful clinical trial. Once aligned, effective communication becomes the lane that keeps all of those ducks in place.
“The beauty of it is that everyone at Fox Chase is invested in the success of clinical trials and wants the process to move quickly and efficiently,” Van Arsdale said. “So, from across all these separate departments and units wanting to make a difference, the SAU provides a focal point, a place to look to for ownership of the activation process.”
Of course, Van Arsdale points to one custom tool as a major advancement for the team: the Study Statusboard.
A Custom Tool Elevates the Process
It is one thing to coordinate all the chaos of departmental activities into an orderly workflow, but it is quite another to get them to flow in harmony.
Enter the findings outlined in “Study Statusboard: Crafting a Clinical Trial Symphony for Success” presented by Rosanna Veggeberg, MS, a director in the OCR, and Pawel Przybysz, BSE, a senior program analyst in Fox Chase’s Population Studies Facility.
The Study Statusboard allows the SAU to track real-time data for everyone involved in the clinical trial process, from the C-suite to the study staff, as the poster says. It is an interactive tool that extracts crucial data points from different source systems used across Fox Chase, such as OnCore (a clinical trial management system) and eIRB (the electronic file management system used by Fox Chase’s Internal Review Board).
“They say you can’t manage what you can’t measure so it was important for us to develop the Study Statusboard to provide transparency into the progress of each trial so that we could leverage real-time insights to address issues or deficiencies as they emerge,” said Veggeberg. “It was important to make sure the system was capable of revealing the underlying data behind the high-level summaries. Creating something that pulls directly from our source systems is important to ensure accuracy and efficiency by minimizing duplicative, manual entry and providing benefit for all.”
Veggeberg places the credit for developing the tool on Przybysz, who was able to bring the vision to life in the form of this unique in-house tool. “I was able to leverage my background here at Fox Chase but most importantly, I would not have been able to create this vision without the expertise and input from essential end users,” Veggeberg said. This included representatives from the other units within the OCR, the contracting team, as well as the different clinical oncology departments, and leadership.
The OCR Roadshow
According to Van Arsdale, the SAU poster presentations not only celebrated Fox Chase’s success at jump-starting the clinical trial activation process, but also helped validate Fox Chase’s approach to the issue.
“We spoke to many people throughout the conference that either were struggling with reforms or hadn’t quite even realized that there was a problem,” Van Arsdale said. “I think being present was good recognition for our department, but also incredibly helpful for our colleagues in the administration of clinical cancer research.”