He began by noting that the pre-requisite to any clinical trials program is a busy clinical practice. Without patients to participate, there can be no trials.
Following closely with that principle is building a culture where clinical trial enrollment is understood to be a component of excellent clinical care. In keeping with the National Comprehensive Cancer Network mantra, the staff at every level of the treatment facility must buy into the idea that “the best management for any patient with cancer is a clinical trial” so the dual goals of research and patient care are never placed in opposition to each other.
Of course, the investigator must have a personal understanding of the NCTN, the various cooperative groups (SWOG, ALLIANCE, NRG Oncology, ECOG/ACRIN, COG, and the CCTG), and their ongoing trials. For a high-level overview of ongoing trials, he recommended the NCTN Trials by Disease Website. But he especially stressed the utility of the Clinical Trials Support Unit website, which provides all of the study documents and ongoing enrollment data for the ongoing NCTN trials. Obtaining access to this resource, at first to understand the landscape and later to consider opening individual trials at one’s site, is an easy early step for any future investigator.
No one can run a trials program alone, so finding or building an enthusiastic and talented team is essential. Dr. Delacroix stressed that a turning point in his own program was the hiring of Eileen Mederos, RN, a clinical trials coordinator who, though her background was initially in trauma trials, has been a driving force in creating and running the cancer trials program since she joined the team early on.
Next Dr. Delacroix discussed building the infrastructure necessary to accrue trials at one’s institution. In some cases, this may involve identifying and pursuing unique opportunities, such as the development of a new statewide research program that occurred in Louisiana early in his career. As he put it “I was the only surgeon to show up regularly for the meetings, so I became a leader by default.”
In other cases, these opportunities may appear initially as weaknesses. Dr. Delacroix found himself without a pre-built infrastructure to support trials when he started at his institution, but he ultimately found that this allowed him the freedom to move more quickly than he might have been able to in a larger, more cumbersome organization.
Finally, he stressed that once an investigator has taken the time to assess their institution, they should not shy away from challenging existing practices. Though it took a lot of effort, Dr. Delacroix credits gaining recognition of the NCI Centralized IRB at Louisiana State University as a major factor in his ability to rapidly open trials at his site.
Once a program is up and running, Dr. Delacroix highlighted two points for building and maintaining momentum. The first is relatively self-explanatory: “Do not open and [then] not accrue.” The second, the concept of “whiteboarding” a trial gives a concrete idea of how to achieve the first. Before deciding to open any trial, Dr. Delacroix engages representatives of every kind of professional who will play a role in the protocol and fleshes out all of the practical details to identify potential barriers and pitfalls. When he identifies a barrier his team cannot overcome, he is not shy about contacting the principal investigator if necessary. By doing this due diligence first, he gives the trial the best chance of success at his institution.
With his characteristic modesty, Dr. Delacroix concluded his list of building blocks of a successful program with “luck”, but with this relatively concrete outline for success, those fortunate enough to hear Dr. Delacroix speak may a little less of luck than most.
Presented by: Scott E. Delacroix Jr. MD, Director of Urologic Oncology, Louisiana State University Healthcare Network Clinic
Written by: Marshall Strother, MD, Society for Urologic Oncology Fellow, Division of Urologic Oncology, Fox Chase Cancer Center, Philadelphia PA @mcstroth at the 2020 Society of Urologic Oncology Annual Meeting – December 2-5, 2020 – Washington, DC