Genentech has more than 40 years of clinical research experience, but it took the magnitude of the current pandemic for us to truly advance the speed at which we could enroll clinical trials as well as vastly increase the diversity of clinical trial participants. With the help of virtual technology, we designed and initiated several new trials to evaluate urgently needed potential COVID-19 treatments at record speed. And, we did this working closely with health authorities to comply with evolving pandemic health protocols while also keeping our existing trials for other investigational medicines running smoothly.

At the start of the pandemic, when we learned that Actemra® (tocilizumab) was being used in China and Italy as a potential treatment option for severe COVID-19 pneumonia, we sprang into action. We evaluated our existing medicines as well as our pipeline molecules for potential COVID-19 treatments, and we set up several trials in an unprecedented matter of weeks. Working around the clock, we leaned on our experience and expertise to design safe, targeted and rigorous trials in the hopes of generating significant data results that we could share with the U.S. Food and Drug Administration (FDA). We got speedy approval to initiate our trials, shattering company records for how fast we could set up large, complex studies.

Given the pandemic’s disproportionate effect on communities of color and other underrepresented groups, as well as our commitment to Advancing Inclusive Research™, we focused on enrolling diverse patient populations - those who have been hardest-hit by the pandemic - in our clinical trials.

“What we have seen in response to COVID-19 is that when the entire healthcare ecosystem comes together with a sense of urgency and purpose we can overcome obstacles in ways we didn’t think possible,” said Quita Highsmith, Chief Diversity Officer. “Not only are we seeing clinical trials designed and approved faster than ever before, but we’re seeing that it can be done while including underrepresented populations.”

In our first Actemra trial, COVACTA, we selected several medical institutions that serve communities of color and underrepresented populations. When New Orleans saw a spike in COVID-19 cases, our on-the-ground team rapidly set up a new clinical trial site at a hospital that treats a large number of minority patients. We streamlined the enrollment processes and adapted the eligibility criteria to capture more traditionally underserved and overlooked patients with COVID-19 pneumonia in our clinical trial.

But we didn’t stop there. When early data showed that the pandemic was disproportionately affecting certain minority populations, our team swiftly approached hospital administrators and physicians treating underserved patient populations to create a second landmark study, EMPACTA, with the core mission of advancing inclusive research. This trial turned out to be the fastest enrolling and most diverse study in the history of our company. One key to our success: expanding the pool of clinical trial sites beyond just large academic institutions to include community hospitals.

During the pandemic, virtual technology has been critical to clinical trials running smoothly. Trial sites have been able to remotely conduct assessments, administer medicines, collect paperwork and even coordinate care at patients’ homes, cutting down the number of trips patients have to make to study sites.

"Our experience with COVID-19 may very well reset the benchmark for everything we do in clinical research,” said Jamie Freedman, head of U.S. Medical Affairs at Genentech. “We have broken barriers we never knew existed, and this will lead to accelerated timelines and efficiencies for inclusive research all across our treatment portfolios."