Put to the Test

Session: Cancer never stops: SARS-CoV-2 pandemic and the effect on research within GOG Partners

Speaker: Brian M. Slomovitz, MD, MS, FACOG, on behalf of GOG-Partners

Staying agile is key to keeping clinical trial participation strong—regardless of the pandemic

Back in March 2020, when the World Health Organization declared COVID-19 a pandemic and everyone burrowed into their home office, there was concern that medical research—and particularly clinical trials—would come to a screeching halt. For GOG Partners, known for clinical and basic scientific research in the field of gynecologic malignancies, trial participation actually increased.

A GOG Partners’ report illustrates that the organization’s study numbers increased by more than 50 percent in 2020, as compared to comparable time periods in 2017 through 2019. In addition, the number of GOG study sites in 2020 almost doubled when compared to 2019, with the number of overall sites increasing by 32 percent between 2019 and 2020.

On behalf of GOG, Brian M. Slomovitz, MD, MS, FACOG, and Broward Health Professor, led an SGO 2021 session, as part of the larger Focused Plenary I: Practicing During a Pandemic: Lessons from COVID-19.

“In response to the COVID pandemic, GOG Partners Research Group acted quickly to change the way we did normal business,” Dr. Slomovitz explained. “In addition to immediate compliance with CDC, FDA, and NIH guidelines with regard to clinical trial management, we also implemented virtual study startups instead of in-person initiation visits; we shipped drugs to patients whenever possible; and we initiated remote monitoring, telemed visits, and remote data collection. In addition, and very importantly, we increased the frequency of our operations meetings and contact with our sponsors.”

GOG also quickly determined that trials conducted at non-university centers fared better than university centers. Adjusting for this fact helped keep trails moving forward and resulted in a GOG Partner’s total overall site participation increase of 33 percent in 2020 as compared to 2019.

As Dr. Slomovitz explained, “Regarding our site participation in 2019, 51 percent were non-university centers and this increased to 54 percent in 2020, with 41 percent more non-university centers participating compared to 2019.

In 2020, GOG trial site participation from university centers also increased, but only by  21 percent.

“In general, large university centers can function as a magnet to a broader region but their activation timelines are often longer. Non-university centers, on the other hand, are smaller, mostly private practices, and are agile and quicker to activate trials,” Dr. Slomovitz said. “And during the worst months of the pandemic, non-university based centers were not as greatly impacted by human resource and financial constraints. In fact, during this time, over 70 percent of accruals came from these non-university centers.”

GOG also found that university centers tended to give COVID-19 clinical trials top priority, leaving little room for gynecologic oncology trials.

In a discussion immediately following the GOG Partners study presentation, Bhavana Pothuri, MD, professor at New York University Grossman School of Medicine, took a closer look at the findings. She led off with a strong positive. “Clearly, this data noting the continuation of clinical trials during the pandemic is important—because we all know that clinical trials are critical to the development of life saving new oncology treatments for patients.”

She did wonder out loud, however, why GOG Partners’ results differ rather dramatically from a similar study published in Jama Network. In that study, Dr. Pothuri pointed out, the results show a 60 percent decrease in oncology trial launches during the pandemic period compared with the pre-pandemic period.

With a nod to the old “which came first, the chicken or the egg” question, Dr. Porhuri also wanted to know if GOG doubled its study count and increased its overall number of study sites in 2020 because of program growth or did the program grow because of GOG Partners’ ability to increase trial participation?

And finally, Dr. Porhuri asked the question that was likely on everyone’s mind: “How can we use this data to plan for future pandemics and natural disasters?”