Technology has enabled clinical medicine to adapt remarkably during the COVID-19 pandemic. Through virtual clinic visits, telehealth has allowed clinicians to evaluate and treat patients while minimizing exposure risk.¹ At the same time, technological advances have supported tremendous shifts in non–patient-facing activities, including clinical research oversight. For decades, the landscape and model for clinical trials necessitated on-site, in-person monitoring and auditing. Information on study participants and events were recorded on paper case report forms. Medical records were documented on paper. The only way that representatives of study sponsors, contract research organizations (CROs), and regulatory authorities could review such data was by traveling to study sites and manually combing through these records.

Recent years have seen a remarkable technological shift. Many clinical trial case report forms—the documents detailing patient characteristics, medications, laboratory and radiology results, and adverse events—are now fully digitized. Most medical institutions have migrated medical records into electronic platforms.² At the same time, regulatory authorities have encouraged a more streamlined approach to clinical trial oversight. In 2013, the US Food and Drug Administration (FDA) released guidance to industry, indicating that 100% source data verification was not an economical use of resources. Instead, the FDA recommended a risk-based approach focusing on critical study parameters.³

Despite these advances and recommendations, clinical trial monitoring and auditing have remained largely on-site activities. For many clinical trials, any remote evaluation is limited to automated, system-generated queries driven by missing, incomplete, or inconsistent data. Potentially driven by a perceived need to verify all source data, study sponsors have continued to send monitors to enrolling sites on a regular basis. Depending on a center's enrollment activity, these visits may last days and may recur every few weeks. Considering the need for travel, lodging, and orientation to a site's documentation, on-site monitoring may be costly and inefficient, often requiring continuous attendance by study staff who would otherwise be engaged in clinical trial conduct.

The COVID-19 pandemic appears to have provided the impetus to revisit the feasibility and utility of remote monitoring. Travel restrictions, quarantines, and safety concerns have prevented on-site monitoring activities at most sites. Along with other adjustments such as remote consent, telehealth visits, off-site diagnostic studies, and shipping of oral study therapy directly to patients' homes, the FDA, the National Institutes of Health Central Institutional Review Board, and the National Cancer Institute have also encouraged remote monitoring.^4,5

In March 2020, following the announcement of the COVID-19 public health emergency, our center immediately suspended all onsite monitoring and auditing until further notice with only rare exceptions. According to an ASCO survey reported in JCO Oncology Practice in May 2020, this change was consistent among the majority of centers surveyed.⁶ At our site, planned, routine audits and monitoring visits were immediately converted to remote format. Sponsors and auditors signed institutional agreements for access to the electronic medical record (EMR), allowing remote source data verification between electronic data capture contents and information in the EMR—including recently implemented electronic research notes. With goals of improving oversight, limiting discrepancies, and avoiding redundancies, the office had completed converting most paper source documentation to electronic format before the COVID-19 pandemic. This fortuitous transition helped to more efficiently manage these operational changes.

Specific comments from sponsors and auditors performing remote monitoring at our center included increased responsiveness of clinical research personnel, ease of following clinical documentation through use of the EMR, and more availability of study teams for exit interviews. In-person interactions between trial sponsors, CROs, and study sites extend beyond monitoring and auditing. Presite selection visits allow sponsor representatives to tour investigational drug pharmacies and other relevant facilities. Site initiation visits allow them to meet face-to-face with the investigators and staff they are entrusting with trial activities. At our site, we are establishing ways to conduct virtual tours through slide shows and video platforms and using video conferencing for group meetings. Table 1 displays these and other strategies.

TABLE 1. Sponsor Visit Types and Tools for Remote Completion

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To what extent will this paradigm shift continue beyond the current pandemic? Thus far, COVID-related guidance from regulatory authorities is planned to expire at the conclusion of the COVID-19 public health emergency. As we and others have shown, there is strong support among clinical research professionals for extending some of these practices, in particular remote consent, telehealth visits, shipment of oral therapy, and remote study monitoring.^6-8 However, rendering these changes permanent features of clinical trial operations also requires buy-in from sponsors, sites, and CROs.

To achieve the acceptance of remote monitoring, it will be critical to document and convey its benefits, which we summarize in Table 2. Also, essential will be continued institutional and industry support for electronic research documentation, improved systems for managing electronic documentation (eg, eRegulatory and other similar data-sharing platforms), establishing more consistent practice around and use of electronic Consent, and electronic Signature. Sites will require investment in infrastructure to implement and maintain secure document management systems described; Sponsors and CROs will need to pivot from their established processes with onsite visits. They can support broader use of virtual platforms to conduct assessments such as prestudy visits and study training. This will also require new standards to meet site expectations for issues such as secure access to EMR and other data-sharing platforms.

TABLE 2. Potential Benefits of Remote Monitoring

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Over the years, clinical trial operations have become bloated. This has led to delays in trial activation, increased burden to research staff, and higher costs. COVID-19 has provided an opportunity for those who plan and design clinical trials to work with those responsible for their implementation and oversight to re-evaluate these entrenched practices. COVID-19–related changes have shown us that remote or virtual methods can allow completion of some study visits in a manner that is quicker, cheaper, and less burdensome, without sacrificing quality. We agree with the conclusions of the ASCO survey. Let us embrace these and other clinical research adaptations to the pandemic and overhaul a process long in need of such attention.