At the onset of the COVID-19 pandemic, our industry led by global regulatory agency direction looked to establish and implement a continuity plan to allow for the ongoing conduct of clinical trials, as well as to maintain patient safety monitoring. Below is an excerpt from the FDA guidance:
“Since trial participants may not be able to come to the investigational site for protocol specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants.”
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19
Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards
March 2020 Updated on May 14, 2020
In support of our pharma/biotech research partners, Bioclinica’s cardiac safety services have been able to implement solutions to allow for the continued centralized monitoring of ECG, blood pressure and temperature.
“As part of our study team’s response to the COVID-19 pandemic, the collaboration with the study team at Bioclinica has provided proactive, flexible and creative solutions allowing us to assure the well-being and safety of patients participating in the study. The solution proposed by Bioclinica of providing home BP devices to the study sites for deployment to the patients home and phone follow-up by site staff provided an effective solution and shows the level of engagement that Bioclinica has with their clients,” comments Jose Carlos Alba, Clinical Operations Manager, Idorsia Pharmaceuticals Ltd.
Bioclinica’s solutions include:
12-Lead and Single-Lead ECG Solutions:
- Adaptation of our existing 12-lead ECG solution, which includes the use of a 12-lead ECG device and study specific laptop to allow for home visit study assessments
- Evaluation of a unique and validated self-applied full 12-lead ECG device for the capture and transmission by the patient at home, with the ECG tracing being automatically uploaded to a cloud environment for management and centralized overread
- Extended ECG and rhythm monitoring through advanced single-lead patch technology
Blood Pressure Monitoring Solutions:
- Modification of ambulatory blood pressure monitoring (ABPM) procedures, which in coordination with study site personnel allows for the ABPM device to be shipped to the participant’s home for application and initiation of the monitoring period, as well as the conclusion of the ABPM and return shipment of the device to the study site.
- For studies which already had Bioclinica’s telemonitored self-measured home blood pressure service (T-SMBP), adaptation of the use of the device and procedures to provide an alternative approach to completing scheduled office BP visits when a study participant is unable to get to the study site.
- For ongoing studies where blood pressure monitoring is a primary endpoint, deployment of advanced automated home blood pressure monitors which are similar in design and algorithm as the existing automated office/clinic-based office blood pressure monitor being used in the study.
Continuous Temperature Monitoring:
- Integrated VivaLnk remotely monitored continuous body temperature patch technology.
“Partnering with our pharma/biotech, CRO, clinical sites and technology manufacturer partners, Bioclinica identifies and implements solutions to support clinical trial endpoints and patient safety, meeting the needs of the unique challenges we are facing with studies in the COVID-19 environment,” says Jeff Heilbraun, MS, VP Scientific and Medical Affairs Cardiovascular Safety Services, Bioclinica.