Modernizing Clinical Trial Conduct

The Modernizing Clinical Trial Conduct Initiative will use data and experience to develop practical guidance and solutions to enable the successes of continuity solutions implemented during COVID-19 while collaboratively engaging with major stakeholders including regulators, patients, sites, and industry groups.

Rationale

The COVID-19 pandemic challenged the way healthcare and the pharmaceutical industries delivered care to patients. Traditional methods for conducting clinical trials were disrupted in ways never seen before. This disruption forced both regulators and the industry to think progressively about how to enable and execute new or non-traditional methods for delivering care to patients. Innovative thinking and progressive regulatory policy 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 modern* solutions to ensure clinical trial continuity 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 is using data and experience to develop practical guidance and solutions that enable additional patient-centric options alongside on-site trial operations, where appropriate. The initiative will also look to engage other major stakeholders including regulators, patients, sites, and industry groups to further enable the modernization of clinical trial conduct.

*Modern solutions or methodologies, for the purposes of this initiative, refers to employing technology solutions or services that enable additional patient-centric options alongside on-site trial operations, where appropriate.

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 Solutions

Maturity Survey Results: Blinded and aggregated findings from voluntary survey to understand collective experience of TransCelerate members deploying eight solutions of focus. The eight solutions in scope included: Direct-to-Patient Shipping, Telemedicine, Home Health Visits, Remote Site Monitoring, eConsent, Digital Data Collection Tools, Electronic Health Record (eHR) to Electronic Data Capture (EDC), and Local Community-Based Facilities.

Operational Complexity Assessment Tool: The Operational Complexity Assessment Tool (O-CAT) is an interactive tool that assesses the complexity or lack of complexity of implementing selected modern solutions in a clinical trial, based on several trial aspects that could potentially impact the circumstances of implementation. The O-CAT tool can help companies identify potential areas of focus during implementation planning and develop mitigation strategies to help lessen or avoid complex circumstances.

Process Frameworks: The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected solutions.

Beyond COVID-19: A catalyst paper formally assessing some of the lessons learned from continuity solutions implemented during the COVID-19 pandemic to identify interventions that the industry may want to further consider.

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.

MCTC Workshop Findings: TransCelerate and the Association for Clinical Research Organizations’ (ACRO) CRO Forum conducted a collaborative workshop to explore root cause challenges and enablers of success for the use of modern methodologies in clinical research; topics include telemedicine, direct-to-patient shipping, home health visits, and local lab usage.

Pre-COVID-19 RBM SDV/SDR Pandemic Practices: A report that organizations can use to help benchmark their Risk Based Monitoring activities pre-COVID-19.

Similar Initiatives

Patient Experience

The Patient Experience (PE) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.

Patient Technology

The Patient Technology (PT) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce patient burden in clinical trials.

Diversity of Participants in Clinical Trials

The Clinical Trial Diversification Initiative has achieved its goal of developing better practice materials for site and sponsors to improve engagement and recruitment of minority patient populations.