Rationale

The COVID-19 pandemic has challenged the way that healthcare and pharmaceutical industries deliver care to patients. Traditional methods for conducting clinical trials have been disrupted in ways never before seen. This disruption has forced both regulators and industry to think progressively about how to enable and execute new methods for delivering care to patients. Innovative thinking and modified regulatory policy have allowed for the implementation of continuity solutions to accommodate the ongoing conduct of clinical trials while maintaining subject safety and data integrity.

The implementation of continuity solutions has impacted all stakeholders (e.g., sponsors, investigators, patients) involved in clinical research. As a result, there is a rich opportunity to understand the numerous lessons learned including both challenges and successes. These learnings can be used to inform future ways of working for industry as well as future policy by regulators. The Modernizing Clinical Trial Conduct (MCTC) Initiative will use data and experience to develop practical guidance and solutions to further enable the successes of continuity solutions implemented during COVID-19. The initiative will also look to collaboratively engage other major stakeholders including regulators, patients, sites, and industry groups.

Benefits

• Acceleration of patient-centric approaches to clinical development
• Greater understanding of innovative clinical trial methodologies that support more effective patient engagement, when compared to traditional methods
• Potential to create efficiencies from accelerating health authority acceptance of innovative clinical development methods

Available Assets

Beyond COVID-19: A catalyst paper formally assessing the lessons learned from continuity solutions implemented during the COVID-19 pandemic to identify interventions that warrant further consideration by industry.

Continuity Solutions Case Study: Selected case studies describing real-world examples of COVID-19 clinical trial continuity solution deployment by sponsors. Includes case studies for Remote Site Selection, Initiation, Monitoring, Closeout, Remote Source Data Verification & Review, Direct to Patient Shipping, Home Health Visits, and Telemedicine.

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