THOUGHT LEADERSHIP

I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?

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.

So, your organization has made the decision to transition to a new eTMF system. Congratulations on taking this step! Depending on your organization and your role, you may or may not have been part of the decision-making process for choosing the system. You may be somewhat familiar with the system or encountering it for the first time. Either way, now that the ink on the contract is dry, it is time to begin making the most of your new eTMF.

Remote interactions—often termed eClinical Technology—are making their way into clinical trials. Precipitated by the COVID-19 pandemic, we have seen an uptick in the adoption of televisits, remote monitoring, and eConsent in clinical trials.