THOUGHT LEADERSHIP

In March of 2020, when much of the country began to impose lockdowns and restrictions on public contact due to COVID‑19, I was in New York City on the monitoring trip noted in my previous blog. In the ensuing months, the nature of clinical trial monitoring was mostly redefined in an attempt to continue crucial studies and participant care. The following are some of my observations and lessons learned in the aftermath of that experience.

I was in New York City on March 1, 2020 when the news reported that the first positive case of COVID-19 had been identified in that state. A pharmaceutical company seeking accelerated approval for one of their products had selected PROMETRIKA to re-monitor their study’s efficacy data after a recommendation from the European Medicines Agency. I ended up traveling to NYC on short notice after learning about an urgent need for a monitoring visit at one of the oldest and largest teaching hospitals in the United States. While leading a two-day monitoring visit at that hospital, it was announced that a coronavirus patient had been admitted to their emergency room for the first time. The research staff in my vicinity were anxious about this invisible, contagious, mystery virus, and it had just been confirmed that their colleagues were interacting with a patient that had been exposed to it. I walked back to the hotel that night and didn’t think anything of it when the song, “The Only Living Boy in New York” came up at random on my playlist.

In recent years, much has been said about Source Document Verification (SDV), the comparison of information reported by an investigator to original source records to confirm its completeness, accuracy, and validity.

Clinical trials leverage the expertise of people in a wide variety of roles — researchers, project managers, clinical data managers, etc. One of the positions with which people may be less familiar is that of the clinical research associate (CRA).

The Massachusetts Biotechnology Council (MassBio) is a not-for-profit organization focused on supporting and advancing the thriving life sciences “ecosystem” in Massachusetts.