By Dr. Gregory Cosgrove, Chief Medical Officer, PFF

The impact of SARS-CoV-2 and COVID-19 is still evident in virtually every aspect of our lives.  Numerous studies, more than 35 as of early June, are underway to identify treatments or vaccines for COVID-19. We are hopeful that additional therapies can be identified, are safe, and protect us all from the SARS-CoV-2 virus.

As different regions of the U.S. have begun to reopen, we need to begin to think about how to kick-start participation in interrupted and/or pending  clinical trials in the pulmonary fibrosis (PF) space.  Analyses done by the WIRB-Copernicus Group (WCG)* suggest access and enrollment into non-COVID-19 clinical trials was reduced from 62% on March 24 to 11% on May 1.  As of last week, 25% of the 1,400 sites across 29 countries have begun enrolling new participants. Note that these statistics are not specific to PF and reflect all non-COVID-19 trials.

This disruption will unfortunately delay the evaluation of many therapies for PF and we must adapt how trials will be performed in the post-COVID-19 era and increase the rate of enrollment to restore the tremendous momentum we experienced over the past several years.  The immediate focus of the scientific community is, appropriately, on COVID-19.  Unfortunately, there is no delay in the impact of PF on our community and we must continue to advance the understanding and treatment of the disease.

Several institutions across the country are implementing a phased approach to restarting clinical research, prioritizing the safety of those participating and staffing any trial.  Differences in the prevalence of COVID-19 and the resources of each individual institution or trial site will affect whether or not a site can re-initiate enrollment in clinical trials. 

Some aspects of clinical trials may remain the same, but many of us hope for a transformation to allow trials to be more convenient, more efficient, and accessible to larger number of volunteers.  This transformation will not occur overnight, but in response to COVID-19, sponsors, advocacy groups like the PFF, and regulatory agencies are beginning to consider ways to adapt.  In doing so, promising agents can be evaluated and, we hope, deemed safe and effective for the treatment of PF.

* https://www.wcgclinical.com/covid-19/ Accessed on 6-8-2020