Clinical Trial Practitioners Grapple with Challenges from Pandemic

Susan Alderman

Susan Alderman, PhD, MSN Ed, RN, Clinical Research Director, UTHSC-Houston, Institute for Stroke and Cerebrovascular Disease

Clinical trial professionals from far and wide are sharing their stories of perseverance and inspiration as the industry comes together to try and conduct clinical trials in the wake of the coronavirus global pandemic.

“It’s currently the calm before the storm” in Paris, says Hubert Lesur, QA-GCP Au, CCRC, with HL Health Support in France. As of March 17, he reported that “all my protocols have been assessed internally with [the principal investigators] as non-vitals (mostly working on rare genetic disease in adults and pediatrics), meaning patients are not called at the hospital, shall respect the full confinement, and everything is to be organized remotely.” Lesur likens the current situation to a “war medicine” mode.

Lesur and team adopted a patient-centric approach, meaning that all non-essential administrative tasks related to research and not directly in liaison with patient management is postponed until further notice. However, “Our trial documentation is still paper based, and it would be too risky with data anonymization and too heavy now to go into remote [source data verification]. [That] can wait,” he says. “Sorry/not sorry for sponsors and” contract research organizations (CROs), he adds. “They will be left with all the time needed  to come and visit after the storm.”

In Texas, the situation is different, yet similar, as the pandemic has still not hit the United States as strongly as France and elsewhere, notes Susan Alderman, PhD, MSN Ed, RN, clinical research director at UTHSC-Houston, Institute for Stroke and Cerebrovascular Disease, a large academic site performing hospital-based research.

“Our partner hospitals have closed for research enrollments. We contacted our sponsors and will do only phone or video follow-up visits until we re-open,” Alderman says. “Safety labs can be done by the PCP [and] imaging tests/biomarkers will be skipped or done later as out of window—per sponsor preference. Our [institutional review board] pushed through emergency amendments allowing [a] temporary alteration to our follow-up visit routine,” she adds.

In addition, all monitor visits are on hold. “I regret that, because we will be inundated when we get back, but [it’s] necessary,” Alderman says.

Research staff, for the most part, are working from home on administrative projects or study-related projects. “We are all capable of remote accessing our work computers and doing WebEx chats. Some query resolutions can be done, as staff have electronic access to hospital records via remote access to office computers,” Alderman says.

She instructed her team to either scan everything to their work desktop that they would need at home or take home anything they could safely take out of office. Manuals and other materials are now sent electronically.

“My newest staff took home reference and training material and my older staff already had it on their office computers,” Alderman says. “We evacuate/work from home during hurricanes, so this is not our first rodeo.”

“In time of crisis, you will face exceptional behaviors and big disappointments: sponsors so far have been understanding, supportive, and flexible,” Lesur says. “It’s much more variable with third parties (CROs, vendors, etc.) and facing some companies who consider their business continuation more important than primary patient safety is tough,” he adds.

Author: Michael Causey