2015Weeknotes

Visiting the Weinberg Center at Mercy Hospital

Visiting the Weinberg Center at Mercy Hospital. Just a few days after our visit to the Columbus Regional Research Institute, the clinical research team at Mercy Hospital’s Weinberg Center in Baltimore hosted us for an intense morning visit. At Weinberg Center, a small core team with one Regulatory Coordinator, two Oncology Research Nurses and a Biostatistician, oversees a total of 29 studies, with 5 additional studies scheduled to begin soon.

Having our two initial field visits back to back, in the same week, was the perfect introduction to the diversity of contexts in clinical trials and the lack of widespread standards from site to site that inform current clinical research practice. If engaging with the managers and staff at CRRI –an independent CRO clinic- allowed us to assess the inefficiencies and misalignments that condition the business of clinical trials, visiting Weinberg Center –an oncology unit within a large metropolitan hospital- showed us how a small, specialized, team of clinical research professionals has perfected a process that works consistently, even if it may be subjected to the operational misalignments at play in the current system.

Andrea, the Regulatory Coordinator, told us that one of the main challenges is the lack of standards for care. She gave the example of how there is not an agreement on what is the standard size for a tumor, and how this lack of a common language adds to the challenging nature of the work she does. To compensate for this, clinical teams often create their own internal Standard Operation Procedures (I didn’t quite get it when she said SOP the first time…), to set a common understanding among co-workers and be clear on how to act consistently.

Sarah, an Oncology Research Nurse, dedicates about 70% of her time to clinical trials and the remaining 30% to patient care. She spoke about how the time frame between screening and randomization, when a new trial begins, is inflexible and often insufficient, particularly if there are international labs involved in the patient screening process and samples need to be shipped overseas for analysis.

Lisa, the other ORN in the team, explained the implications of introducing amendments to the clinical trial protocol. Every new amendment implies re-educating all staff involved in the trial, often via webinar. Amendments must be submitted to the IRB for approval and, once that step is completed, all patients in the trial must sign a re-consent (in one instance, she said, patients needed to sign 9 re-consents in the same trial).

From Ryan, Mercy’s biostatistician, we learned that his work in the 1 to 5 projects he runs at a given time is about mixed modeling in data analysis. He told us that there is often a lack of understanding about the value of data analysis in clinical research on the part of the medical community, a circumstance that pushes him to become an ad-hoc biostatistics educator as needed.

From the beginning of this project, including the early drafts of the research plan, our team has been committed to field visits as an essential tool toward advancing our research goals. The first two field visits we have completed in June have given us the opportunity to calibrate some of the tools in our field work toolkit, such as direct observation, fact-finding, conversations with key staff, etc. These experiences have proven how critical it is, in a research project like ours, to understand the current system as we see it and experience it on site. The gap between information coming from literature or conversations with experts and the deeper understanding coming from direct observation and analysis became evident at the Weinberg Center, and taught us that the nature of clinical research in oncology, with trials designed around just 2 or 3 patients per study and multiple study sites, results in a process that has long cycles of study and research before studies may actually begin, in contrast with most of the trials done at CRRI, where the time gap between design and implementation is much shorter and direct due to the nature of the trials that are conducted there.

A word of caution: field research work is much harder than it seems. It is, also, retroactive in nature. It demands an active predisposition to discovery, beyond the evident, and a state of heightened perception of what one sees and hears. In my case, after many years of conducting field work, I know that it is only days after the visit when I remember details and evidence that seems key to the project even if, at the time of the visit, might not have seemed that way.

At the early stages of our field research work in clinical trials, engaging with the staff at the Weinberg Center and having the luxury of their time to help us understand how clinical research is really conducted, reaffirmed our initial premise that our project’s success hinges on our ability to understand the current clinical trials system from direct, on site, involvement and insightful observations.

By:
Enrique Martinez