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.

Remote Monitoring

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.

Home Visits

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.

Careful Coordination

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.

The Critical Issues You Need to Track During a Clinical Trial

Congratulations! You have gone through all the necessary steps to launch a clinical trial. Now it’s time to move on to the next one, right? Wrong! A successfully managed clinical trial requires ongoing tracking throughout its duration. Careful monitoring ensures your research institution remains compliant and that your site is compensated properly for the study.

Follow our series on the key critical issues you need to track throughout a clinical trial.

Part Two — Budgeting and Maximizing Revenue

Research sites that have a clear process for clinical trial budgeting as well as billing and collections can ensure their research efforts are feasible and sustainable.

An initial process that thoroughly accounts for every expense related to the clinical trial will result in a thoughtful budget that supports site resources. In addition to completing a Coverage Analysis to determine research procedures from standard of care procedures, research coordinators should consider costs that may be “hidden” or less obvious such as protocol specific training, or time needed for site initiation and monitoring visits. A detailed budgeting process up front will make tracking study activity and expenses much easier. Besides the expenses related to patient visits, budgets should include line items that cover time and effort of the investigator, the coordinator, and other research personnel for the various administrative tasks necessary to effectively carryout the requirements of the study. These administrative tasks can include:

  • Screening for eligible participants
  • Responding to sponsor queries
  • Reviewing safety reports
  • Preparation of regulatory documents or maintaining the regulatory binder

Throughout the study, it is important to track not only visits and procedures, but also items for which you need to invoice the study sponsor or CRO. Invoiceable fees can include procedures done outside the study visits, such additional scans, lab tests, or unscheduled visits. If patients are reimbursed for travel or other expenses, these should also be tracked.

To ensure research billing and collections are maximized it is essential to have strong systems in place to track all study visits and procedures completed throughout the study and record all the activity in comprehensive invoices. It is also important to track study payments and accounts receivables. Reconciling payments received from the sponsor/CRO to the study budget and to the actual study activities completed is critical. If you do not receive payment for all study activity your cash flow and profitability are impacted.

Careful tracking of all study activity, billable expenses, and sponsor/CRO payments help ensure that your site will have positive cash flow and cover its costs related to operating clinical trials.