Making the Move to Virtual Visits: Regulatory Considerations

Kenneth G. Faulkner PhD | |

Virtual telehealth visits have been around for many years, but they have become increasingly accepted as a result of the COVID-19 pandemic. In the clinical research community, a shift to virtual visits has become a necessity as clinical research sponsors scramble to provide alternate approaches to monitoring patient safety and study integrity in a world where clinic visits are difficult or even impossible.  

In fact, a recent industry survey showed that 82% of clinical trial sponsors are making changes to existing trial models because of the pandemic; of those, nearly three quarters are implementing telehealth systems that enable patients to ‘meet’ with investigative site personnel via video chats (Figure 1). 

Before moving from traditional to virtual visits, sponsors should keep in mind important regulatory, technological, and patient consent-related considerations, which we review here.

Virtual Clinical Trial

Figure 1:  Patient devices and telehealth systems are primary data capture tools in virtual trials (Source: ERT Survey, May 2020).

Virtual Visits 101

During a virtual visit, the people involved are physically separated and are only able to communicate using telephone, video, internet, or some other mode of distance communication. The main feature of a virtual visit is the complete physical separation between research staff and the patient.

When migrating to virtual visits, there are several important considerations regarding use of communication technology, regulatory reporting of alternate data collection methods, and keeping patients informed of any changes to the protocol and procedures. FDA guidance (1) has indicated several areas which need to be addressed to ensure patient safety and study integrity are maintained.

Virtual Communication

The simplest form of a virtual visit is the use of a telephone for voice only communication.  However, most virtual visits can be greatly enhanced by adding visual interaction through many different and widely available video conferencing tools.  

While the FDA does not specifically recommend any technology platform, they have required that any communication tool be evaluated for the ability to maintain patient privacy (1).  Patients and site staff should be in a location that prevents inadvertent sharing of any information to others who may be in the area. Furthermore, investigators and study personnel should be properly trained on the best practices for video conferencing and telemedicine visits. This includes how to perform interviews to avoid introducing bias through improper presentation of questions.

Before starting the virtual visit assessments, both the investigator and the patient are required to confirm their respective identities according to the plan developed by the study sponsor (Figure 2). This might include verifying photo identification documents through the video conference, or exchange of photo identification documents through mail or email. The date and time of the virtual visit should be documented, as well as the location of the patient and investigator/site staff (1).

Figure 2: Investigators and patients are required to confirm their respective identities before beginning a virtual visit.

Protocol Changes and Deviations

The FDA understands that there will be required changes to the protocol and procedures as the result of the move to virtual visits. The basic guidance is to keep in communication with the FDA or other regulatory authorities regarding any changes, as well as the IRB overseeing study conduct.  Documentation is essential, including information on why a change was made and how the changes may impact patient safety and study integrity.  

It may be necessary to re-consent patients as a result of any changes. This should be discussed with the IRB.  If updated consent is required, the FDA has provided for alternate consent procedures such as e-consent tools, email or mail exchange of documents, and verbal consent with appropriate documentation and witnesses. Recently, the FDA provided open access to the electronic consent tools available through the FDA MyStudies App as a way to facilitate the informed consent process (2). 

Potential Impacts on Study Power and Statistical Analysis

As with any change to a planned investigation, there may be an impact on the statistical analysis of the data. Most notably, missing data and alteration of the data collection methods could introduce additional variability into the study.  It is important to limit variability as much as possible when changing to virtual visits. For example, FDA guidance recommends limiting the variety of methods used for virtual communication (1). Specifically, using both telephone and video conferencing in the same study may increase variability and should be avoided.

The potential impacts associated with any protocol changes should be considered and adjustments made to the statistical analysis plan before final database lock. This may include:

  • A comparison of results obtained through virtual visits compared to face-to-face visits, investigating differences in compliance by mode of data collection, and use of methods to adjust for missing data. 
  • The need to exclude data  from evaluation if evidence indicates an issue with the results. 
  • The recruitment of additional patients and study sites to compensate for any additional variability caused by either missing data or protocol changes.  

Conclusions

With proper planning, virtual visits can be successfully used for clinical trials while maintaining patient safety and study integrity. The advantages for patient safety and convenience assure us that virtual visits will be a major part of clinical research going forward.

Kenneth G. Faulkner, PhD is the Vice President of eCOA Science at ERT

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