How COVID-19 Has Impact Clinical Trial Budgeting
As COVID-19 swept across the United States earlier this year, many research centers found themselves pausing or stopping clinical trials and shifting their work from an office or clinic to their homes. Clinical research staff pivoted their focus to support the COVID-19 response, or to launch critical studies focusing on COVID-19.
As some research staff return to campus, research sites are reviewing their study budgets and making important adjustments. We have outlined some of the key areas that may have clinical trial budget impacts.
Without the ability to visit campuses in person, sponsors must conduct monitoring visits virtually and remotely. It may seem like this is less time consuming and convenient. In fact, it may take more time and coordination to prepare medical records to review remotely from the research site perspective.
Study coordinators must collaborate with their institution’s IT teams to develop HIPAA-compliant remote access for sponsor or CRO study monitors. Within each institution, there may be many security steps that must be achieved prior to granting access to external parties. It can even be more complicated when there is a lot of staff turnover; monitors can change frequently during the research study lifecycle. In some cases, research staff might not have the proper equipment at home to access and/or transmit records. Research staff may have to print or scan medical records, then redact them and send them securely to the monitor.
Research sites should have their staff carefully track time spent on the extra steps and be sure to account for added time and effort in their budgets. Under pre-COVID circumstances, sponsors often provided arguments for not covering monitoring visits as it was considered a part of doing business. However, in the case of remote monitoring, coordinators and/or analysts should have a conversation about including the extra staff time and effort in the budget. This should include the time and effort of the IT department.
Telemedicine and Its Limits
For the sake of patient safety and whenever possible, office visits have shifted to virtual visits over the phone or videoconferencing. For patients in clinical trials, it could include engaging with the attending investigator, or a consultation with a nurse or coordinator. It is important to keep track of who participated in the virtual visit and to consider negotiating virtual visits as an item to be invoiced to the sponsor if the visit is not already covered as part of the sponsor’s budget. Keep in mind the time and effort of IT, or cost of HIPAA-compliant telecommunications technology to establish secure communication pathways among the patient, the investigator and research staff, for the purpose of the research study. If you are using online meeting platforms, such as Zoom or Microsoft Teams, there are costs associated with these applications as well.
In some cases, the protocol may call for a specific procedure such as IV drug administration. In this case, a visiting nurse or a contracted home health service may have to visit the patient’s home. The need for such a service should be identified and the logistics should be discussed with the sponsor. Budgets should include these visits as well as any costs for contracting and coordinating home health services.
COVID-19 Safety Measures
In some institutions, on-site staff are undergoing frequent COVID testing, sometimes twice a week. They also have had to stock up on personal protective equipment (PPE). As sites return to meeting study participants in person the use of PPE may increase. Consider including costs for some PPE supplies in your study budget when in person visits are required.
Many research coordinators shifted their focus to COVID-19-related projects. Many of them are now turning their attention back to research that had been put on hold, or on emerging new research projects.
Institutions have a mix of staff working at home and working in clinical environments. Administrators are encouraging more virtual meetings and contactless interfaces. This leads to a higher reliance on IT’s involvement in research to provide secure networks and communication. This, also, may mean a higher level of coordination with pharmacies, radiologists, and other clinical staff.
The return to campus and the restart of many trials requires a close look at budget to evaluate if there are any anticipated COVID-19 impacts, even if the study is not specific to the pandemic.