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With the Coronavirus causing significant disruptions in the clinical trials industry, Sponsors should expect data quality issues due to missed visits and a reduction in enrollment rates.
As the Coronavirus takes the world by a stranglehold and causing major disruptions in business and travel, the clinical trials industry also faces significant challenges. I recently read an article1 where most biopharmaceutical companies expressed no concern over the disruptions caused by the virus, with Bristol-Myers Squibb indicating, “it had seen no impact to its clinical trials at this time,” and Merck saying, “it did 'not believe' that any of its global studies are at risk.” I have a different perspective on the matter; I run four study sites and can tell you that we already are experiencing disruptions in our clinical trials that will cause issues down the line.
Since the Coronavirus emerged, many clinics and medical centers are focusing their efforts on containing the virus. Some of my sites are in the process of separating their offices to see patients who are experiencing flu-like symptoms in one location, and those who are not, in another place. Moreover, the focus is shifting towards staff preparedness for infectious disease prevention, such as ensuring proper medical protocols are followed to avoid Coronavirus transmission (i.e., ordering masks, scrubs, and training staff on infectious disease processes). Unfortunately, these activities are taking away valuable focus and resources needed for running clinical trials.
We have already experienced subjects missing their visits because of two factors: (a) fear of the Coronavirus, and (b) travel disruptions. Patients, both younger and older, but, especially older, are canceling their study visits because of concerns around the Coronavirus. This is, subsequently, creating a strain on site staff, Sponsors, and IRBs to document and report protocol deviations.
Our recruitment campaigns have come to a complete halt, as the vast majority of our leads generated from recruitment campaigns are afraid to come to our study sites due to coronavirus concerns. Additionally, addressing protocol deviations and infectious disease preparedness have suffocated site staff resources for calling leads and prescreening patients.
We are noticing an uptick in adverse events with patients reporting flu-like symptoms. This is straining PIs’, data management’s, and study coordinators’ time, as they have to report the AEs to Sponsors, and PIs have to evaluate whether the AEs are investigational product related.
While many patients will still decline to come in for study and screening visits, offering transportation support, such as a black car service, helps with bringing patients into the study site. If you are a Sponsor, consider offering this service to sites. If you are a site, reach out to your Sponsors to obtain approval for temporary transportation reimbursement-most sponsors will approve, as data from proper protocol compliance are critical.
Once subjects stop coming in for study visits, they start to forget about the study and are more likely to drop out. Consider engagement initiatives to keep the subjects interested. At my sites, we are maintaining subject engagement by tracking all actively enrolled subjects who have not come in for visits and calling them daily to check in on them and ask them whether they have adverse effects. Site staff also continually engage subjects to reschedule missed visits, offer transportation assistance, and confirm study visits a day before, and on the same day of the visit.
At our sites, we are raising awareness with subjects by being upfront about our infectious disease initiatives. We explain how the procedures we put in place help with preventing the spread of Coronavirus. We have found it helpful to reassure subjects that they are coming into a safe environment.
The Coronavirus outbreak is causing significant disruptions that will create a ripple across the clinical trials industry. Sponsors should expect data quality issues due to missed visits and a reduction in enrollment rates. Investing in patient engagement initiatives and coordinating directives with study sites should help with mitigating risks caused by the Coronavirus disruption.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.