A Realist’s Look at Best Business Practices for CTO Management

Ryan Monte
Senior Product Marketing Manager, Forte
April 19th, 2019

At our recent 2019 Spring Onsemble Conference, attendees were able to choose from a variety of tracks and almost 60 unique sessions during their time in Dana Point, CA. Among those sessions were discussions led by leadership from top clinical research institutions across the country. Session topics included leveraging analytics to make strategic business decisions, easing the burden of administrative processes, recruiting and retaining staff and more. 

In his leadership-focused session, Nick Fisher, Executive Director of Research & Business Administration at Siteman Cancer Center at Washington University School of Medicine and Barnes Jewish Hospital, discussed his ideas for how operational leadership can continue to push their institutions and the clinical research industry forward. Instead of focusing on tried and true methods and best practices for CTO management, he posed a series of questions, challenging industry norms to find new solutions to common issues. 

Challenging Our Current Processes

Fisher started his presentation with a discussion related to how internal funding strategies affect outcomes for NCI-designated cancer centers, suggesting that centers align their investments with accrual targets related to their strategic goals and with external review timelines. He then shifted to discuss how unrealistic feasibility workflows and expectations in many centers can slow down investigator-initiated trials without providing much benefit. He discussed the high cost of “ultra-efficiency” and warned against creating processes that ultimately will drive inverse results.

On a similar note, he provided a high-level look at the costs and benefits related to monitoring accruals and potentially closing trials based on those accrual totals. He argued that analyzing the success of trials based only on accrual was shortsighted, and potentially allowing low-accruing trials to stay open could allow patients to continue treatments that would otherwise be unavailable to them. While centers should do their best to avoid inefficient trials, they should ensure they understand the true value of the study (and its accruals) before considering closing it.

Fisher then discussed the “shift” in focus that cancer centers typically go through as they establish themselves, going from a phase II/III focus to phase I/II. During (and potentially after) this transformation, many centers struggle to meet accrual goals for those phase I/II studies. As more and more consortia and other networks develop throughout the industry, he emphasized the value of leveraging partnerships to help expand the reach of your center. In addition to the expanded reach, the additional resources within your network can allow you to continue participating in the phase II/III studies that are beneficial to your patients and your center.

Shifting from Trial Matching to Patient Matching

As he closed out his presentation, Fisher highlighted the wide array of clinical trial matching solutions available to take existing EHR-sourced patient data and match them to an existing clinical trial. Many of these services offer immediate, push-button trial matching, though they typically fall far short of the results they promise. While the ultimate goal of matching patients to trials is still a worthwhile endeavor, Fisher suggested that clinical research leadership find other methods for trial matching until the technology improves.

Fisher then presented a different idea: flip the concept of trial matching to instead focus on “patient matching”. He suggested that, instead of matching current patients to existing trials, centers place an emphasis on conducting trials to match their patient population. Many centers have only a small fraction of their patient population on clinical trials. Fisher suggested finding the common characteristics within that underserved population and taking those into consideration when developing new investigator-initiated trials. Referring to trial matching, Fisher said “For years, lots of smart people have spent a great deal of time, effort and money trying to develop a solution to this problem. We’re not quite there yet, but this [patient matching] solution has great potential for us to increase accruals, better serve our patient population and strategically align our efforts with our goals.” 

One common theme throughout Fisher’s presentation was taking a step back and finding common sense approaches to internal funding, accrual monitoring, patient recruitment and other challenges that those in operational leadership deal with every day. By focusing on what you’re able to control, understanding your institutional goals and the rationale behind them and keeping your day-to-day operations aligned with those goals, you can ensure that your center is following an effective, sustainable path to success.