Modernizing Clinical Trial Conduct

The Modernizing Clinical Trial Conduct (MCTC) Initiative is focused on the evolution of clinical trials to include broad adoption of technologies and solutions, as appropriate, that enable greater patient choice and flexibility while maintaining patient safety and data reliability.

Rationale

The COVID-19 pandemic challenged the way healthcare and the pharmaceutical industry 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 decentralized methods* to accommodate the ongoing conduct of clinical trials while maintaining patient safety and data integrity. The implementation of decentralized methods to ensure clinical trial continuity has impacted all stakeholders (e.g., sponsors, investigators, regulators, and patients) involved in clinical research.

The Modernizing Clinical Trial Conduct (MCTC) Initiative seeks to create solutions that help establish these decentralized methods as integral to clinical trials to create a more inclusive, accessible and innovative clinical trial ecosystem. By embracing these solutions, TransCelerate strives to foster innovation and transform clinical trial execution to address existing barriers to bring clinical research closer to the patient, while minimizing site burden.

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

Benefits

Greater understanding of innovative clinical trial methodologies that support more effective patient engagement, when compared to traditional methods
Anticipated efficiencies from accelerating health authority acceptance of innovative clinical development methods
Potential to create additional ‘optionality’ for patients participating in clinical trials via traditional or decentralized methods
Potential improvement in patient choice, experience, and access to clinical trials

Related 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.

Participant Data Return

The Participant Data Return initiative seeks to develop pragmatic resources to enable sponsors return of meaningful individual data to clinical trial participants who opt in to receive it in order to build trust in the research enterprise by enabling access to an individual’s data for their personal care, as appropriate.