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.

We knew that immunotherapy finally had a breakthrough when James Allison and Tasuku Honjo received the Nobel Prize in Physiology or Medicine in 2018 for “discovery of cancer therapy by inhibition of negative immune regulation.”

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.

Having worked in the world of clinical research for 15 years, I can’t help but be baffled by the rampant misuse of the word “de-identified” as it relates to the classification of clinical data sets.  In the United States, “the HIPAA Privacy Rule provides federal protections for personal health information [PHI] held by covered entities and gives patients an array of rights with respect to that information.”  De-identified health information is not PHI and thus is not protected by HIPAA.

It’s a common misconception that if you remove patients’ names from a set of clinical data, then it becomes de-identified and is no longer governed by HIPAA.  However, to make a set of clinical data truly de-identified, you must remove much more than just the patients’ names. 

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS). It is hypothesized that CNS auto-reactive T cells are stimulated in the peripheral circulation to become active and proliferate, with subsequent migration into the CNS compartment.