The COVID-19 pandemic created numerous challenges for companies involved in clinical trials. At the same time, the pandemic has created an urgent need for remote monitoring by both companies wishing to keep their trials moving forward and for companies initiating new trials on schedule.
The traditional onsite monitoring visits, where monitors are required to check the data entered in the case report form (CRFs) against source, to ensure that the protocol is executed correctly, are obviously less practical during COVID-19 period.
Regulators (FDA, ICH and Iso) accept and encourage sponsors to explore more effective monitoring strategies. There is now an acceptance of moving away from the practice of 100% SDV of patient data. The regulatory bodies understand that sponsors need to look to improve the efficiency of cost and safety in conducting clinical trials, especially during COVID-19, when monitors cannot enter clinics and traveling is difficult and restricted.
What should you consider when implementing remote monitoring?
- For the remote monitoring plan, a risk monitoring assessment should be implemented as it is an important component of any remote monitoring plan. Risk based monitoring evaluation is a systematic process put in place to identify, assess, review, communicate and control the risks associated throughout the clinical trial path.
- The remote monitoring plan should be adjusted when there is a need to consider on-site monitoring visits. Note: high number of protocol deviations/violations, poor data quality, high rates of AEs may require additional visits to:
- Re-train and mentor study personnel.
- Data verification
- Choosing the platform for collecting patient’s data wisely. An advanced technology tool (EDC) with superior modules can support an effective remote monitoring, while enabling a fast data entry.
We recommend considering:
- e-ICF; Electronic informed consent forms enable patients to review and electronically sign the form online
- e-Source; Electronic source documents enable near real time monitoring, reduce source data verification and number of monitoring visits.
- e-Pro; Electronic patient-reported outcome combines multiple sources in one central platform, ensuring high quality data.
- Documentation Center; Highly recommended tool that allows the sponsor to preserve and track essential related documents while maintaining user Login by role.
- Video visits (WebEx, Zoom, TCs, etc.)
- Local laboratory results should be considered for safety decisions, as there may be a need for critical laboratory tests (imaging, diagnostic etc.) to be performed while trail participants cannot reach the site.
- Changes in study visit schedules, missed visits, or patient discontinuations may lead to missing information. It is important to capture this information in the case report form (CRF), explaining the rationale of the missing data, including the connection to COVID-19. This information, summarized in the clinical study report, will be helpful to the sponsor and FDA.
The industry moves forward, promoting a more risk-based approach. Remote monitoring can be a beneficial progressive process. Advanced technologies can support remote monitoring.