Kathleen Tiefenwerth on Conducting Clinical Trial Operations During COVID-19

Preventing, containing, and mitigating any spread of the SARS-CoV-2 virus has consumed infectious disease clinicians as well as refocused research sites where clinical trials are carried out. Some have even paused work on other disease-related trials. Kathleen Tiefenwerth, a senior clinical research associate (CRA) in Westat’s Clinical Trials Practice, says that the challenges are the catalyst that invigorated staff to work around barriers, rethink procedures and consider new tools, and strengthen risk assessment protocols that will benefit any kind of clinical trial in the future.

Ms. Tiefenwerth has extensive experience managing and directing the activities of teams of CRAs assigned to clinical trials. She performs quality review of monitoring visit reports and works directly with sponsors to guide site management as well as clinical monitoring goals and priorities. She is currently the clinical lead for a study of a COVID-19 therapeutic. “Protecting patient safety is paramount,” she explains. “Westat’s role is to ensure that trial sites adhere to protocols for patient safety. Site monitoring is a key piece. Pre-pandemic, we would visit each site in person, talk with staff, report on required infrastructure, and collect all licensure materials. We would also provide hands-on training for the staff on how to use equipment and make sure each site is entirely ready to go, with laboratories and databases all set up. As a study moves forward,” she continues, “we visit in person to review data against source documents, like patient medical records, and make sure everything reconciles on site. There’s face-to-face interaction, which helps to develop rapport.”

Then came COVID-19.

Sites restricted access, and some sites prohibited in-person visits. “Site monitoring is very challenging to do remotely,” Ms. Tiefenwerth explains, “but we found ways to enhance the infrastructure to meet the standards.” With Institutional Review Board approval and under Food and Drug Administration recommendations, checklists were incorporated in place of direct review of informed consent documents. Questionnaires were also distributed to the sites to determine on-site capabilities. “We employed whatever strategy was needed to offer sites ideas and support,” she adds.

Many monitoring activities pivoted to virtual access. Remote access to medical records is now required, though some sites did not have the technology to accomplish this task. Westat worked through contract issues and with the IT departments at various sites to set up access as needed for sites that would allow remote access. Westat’s IT solution was to set up secure methods to allow documents to be uploaded to Westat site monitors while protecting patient confidentiality. “We examined all ways so that sites did not have to manually redact hundreds of documents,” notes Ms. Tiefenwerth. “We established proper systems, working closely with sites to upload source data. Every step of the way, we evaluated how to accommodate individual sites while meeting standards efficiently.”

Of the lessons learned during the pandemic, Ms. Tiefenwerth says it is key to carefully consider assumptions: “We’re building in risk assessment for future studies when the normal process is disrupted by factors outside our control. We’re thinking past the barriers, using new tools, making the infrastructure available through remote access, and integrating new ideas into disaster planning to ensure clinical trial operations can operate in this new normal.”