Researchers are facing great challenges in keeping cancer patients and other immunocompromised individuals safe as they strive to continue their important, life-saving clinical trials during the pandemic. According to the Centers for Disease Control and Prevention (CDC) cancer patients are potentially at a higher risk of severe illness from COVID-19, so many are advised to avoid leaving their homes unless it is absolutely essential and to limit their contact with others.
This presents a problem for clinical trial sponsors, who traditionally rely on patients physically attending investigative site appointments for routine aspects of their clinical trials, including recruitment, check-ups, dosing, and safety and efficacy data capture. If patients are advised to limit contact with others, how can clinical trial sponsors ask them to continue traveling, sitting in crowded waiting rooms, and exposing themselves to more individuals that could increase their risk from COVID-19 or other infections?
In an earlier blog, we addressed how technology is helping oncology researchers accelerate the development of new cancer treatments. Here we present how virtual trial technologies are going a step further in ensuring clinical trial patient safety during the pandemic and beyond.
The Impact of Virtual Trial Technologies on Oncology
Some aspects of oncology clinical trials will continue to require patients to visit investigative sites or will need to be conducted remotely (via a home health visit or at a remote site). For instance, dosing visits that require injections and infusions, as well as certain tests (such as medical imaging) still need to be conducted by a medical professional with the proper training and equipment. But sponsors can minimize cancer patients’ exposure risk by reducing the time spent at face-to-face visits. It also is important to reduce the need for additional non-treatment visits by implementing proven virtual trial technologies, including:
- Virtual Visits: Consultations between patients and investigators via a simple, secure app or web interface offers a convenient and simple way for patients to ‘see’ their clinicians from the comfort of their own homes, reducing the need for face-to-face site visits (Figure 1).
- Digital data collection: Clinical trial data can be submitted directly by the patient using devices provided to them or via their own smartphone, tablet, or computer. Many safety, efficacy, and quality of life endpoints can be collected in this way, greatly reducing the time required in the clinic, including:
- ePROs (Electronic Patient Reported Outcome Assessments)
- Cardiac measurements: blood pressure via ambulatory blood pressure monitors and ECG readings using a 6 lead ECG device integrated with a patient’s own mobile phone
- Activity level data tracked using fitness monitors, integrated with a patient’s mobile phone
- Photographs or videos taken at home
- Remote visits: Trained site personnel can transport portable devices with all required consumables to the patient’s home or alternative location and then follow data collection protocols as they would in-clinic. These options include:
- 12 lead ECG data collected by provisioned Cardiac Safety device options
- Respiratory testing using portable spirometry systems; Additional devices can be integrated to capture additional endpoints such as ECG, FeNO and Forced Oscillometry data
- Simple imaging procedures, such as skin photography or ultrasound imaging using portable devices with trained staff to collect the images
- Test sample collection such as blood/urine and physical exams that requiring trained personnel
Figure 1: Virtual Visits enable patients to ‘see’ their clinicians from the safety of their own homes
Virtual trial technologies are being swiftly adopted by the pharmaceutical industry, and for good reason. With many trials being halted as a result of COVID-19 stay home mandates, clinical trial sponsors need proven solutions that enable their important trials to continue. These same technologies may continue to be used after the COVID-19 pandemic is contained, as they provide additional convenience and safety benefits for many patients.
Proven virtual trial technologies, such as those presented here, offer a solution to the many challenges pharmaceutical companies are facing. These tools are especially valuable in oncology trials, where patient safety is of utmost concern, and limiting patients’ exposure to COVID-19 has become an important objective in the current era of clinical development.
Kenneth G. Faulkner Ph.D. is the Vice President of Scientific Services at ERT