Virtual Clinical Trials

Terminology for Modern Clinical Trials

New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow for clinical trial teams to collect data remotely where possible, removing the need for participants to travel to the trial sites for in-person assessments. Trial staff can meet with participants through telehealth tools, perform the consenting process, and collect trial data without the participant ever having to set foot in the trial site.

Virtual data collection offers many benefits, so the use of these strategies has increased over time, as has acceptance of participant-reported data as reliable. The need to maintain clinical research momentum in the face of restrictions due to the COVID-19 pandemic has accelerated the adoption of these strategies. We will explore the benefits and limitations of these methods in this blog series, but first, let’s clarify some of the buzzwords that you may be hearing.

Electronic data collection (EDC) refers to a system of electronic case report forms (CRFs) on which to record trial data. The EDC system contains the trial’s database, but provides a simple interface for trial staff to enter data from participants’ records or procedures. EDC replaces paper CRFs, which would have to be scanned or transcribed into the trial database, adding extra steps to the process and a higher likelihood for errors to be introduced. EDC systems are used for traditional trials as well as virtual trials.

Virtual clinical trials are trials where all of the trial data can be collected from participants remotely, without requiring visits to a trial site. Data may be collected through tools like telehealth appointments, smartphone apps, web portals, wearable sensors, or home visits by nurses.

Obviously many clinical trials require exams or procedures that can only be done in a clinical setting (e.g., a device implant procedure). A trial can still benefit from the use of remote data collection where appropriate while decreasing the burden on participants and caregivers. Trials that are designed with a mixture of in-person visits and remote data collection are known as hybrid clinical trials.

Remote data collection strategies are collectively known as electronic clinical outcomes assessment (eCOA), and may include:

• Patient/Participant reported outcomes (ePRO): any information provided to the clinical trial team directly by the participants. This typically includes diaries and questionnaires that are completed by the patient on a website or mobile app. Depending on the data collection tools being used, the information can be mapped directly into the trial database.
• Clinician reported outcomes (eClinRO): trial site staff assess patients and record the results directly into a data collection application or web portal, as opposed to gathering information from the participants’ medical records and transcribing it into the study database.
• Observation reported outcomes (eObsRO): similar to ePRO, participants’ caregivers in the home setting provide information about the participants’ experiences via web portal or mobile app, based on their observations and interactions with the participants.
• Performance related outcomes (ePerfO): trial data that stem from activities performed by the participant. These can be submitted directly to the data collection application via a tracking device like a wearable sensor or a mobile device worn on the person.

The need for virtual and hybrid clinical trials is quickly evolving and necessary during this time. Our next post in this series will discuss how eCOA tools can help simplify data collection and achieve clinical trial objectives for sponsors.

Contact us to learn more about how to design and carry out efficient clinical trials in the era of social distancing 855.463.1633/medinstitute.com/askmed@medinstitute.com.