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. To support TransCelerate’s strategic priority to improve patient experience, a team within TransCelerate’s Modernizing Clinical Trial Conduct (MCTC) Initiative was tasked with exploring what a more patient-centric clinical trial could look like in 2031 and identifying potential areas where TransCelerate could play a role to enable this vision.

*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

Initiative Solutions

The following assets are now available:

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.