Modernizing Clinical Trial Conduct Solutions

The COVID-19 pandemic required swift implementation of innovative and modern solutions to protect participant safety and enable clinical trial continuity. The pandemic catalyzed the expansion and acceleration of solutions as well as the establishment of new ones. Extending the use of these solutions beyond the pandemic may benefit patients by lessening the burden of participating in clinical trials and allowing more patient choice and flexibility in clinical trial conduct. The Beyond COVID-19 catalyst paper described the broad categories of continuity solutions utilized, the challenges related to their use, and the factors that made implementation successful.

To better understand the collective experience of TransCelerate members deploying these modern solutions a maturity survey was conducted. This document presents the aggregated findings from this survey. The aggregated maturity level data revealed a mix of maturity levels with most respondents indicating modern solution use as Limited or Exploring.  This finding suggested that resources to support solution implementation would be particularly useful.

TransCelerate leveraged the key findings of the Beyond COVID-19 catalyst paper and the maturity survey to inform the creation of new solutions, tools and processes to help facilitate the implementation of modern clinical trial solutions within the healthcare ecosystem. Modern solutions or methodologies, for the purposes of these tools, refer to employing technology solutions that enable additional patient-centric options alongside on-site trial operations, where appropriate. The Operational Complexity Assessment Tool (O-CAT) and Process Frameworks are complementary solutions. While they can be used on their own, they provide the most value when used together.

These two solutions encompass seven modern solutions:

Digital Data Collection ToolsLocal Community-Based Facilities
Inclusive of patient service/support centers
Direct-to-Patient ShippingRemote Site Monitoring
Electronic Informed ConsentTelemedicine
Home Health Visits

Are you looking for a tool to help assess operational complexity before implementing a particular modern solution in a clinical trial?

Has your organization already decided to implement one or more modern solutions but is looking for considerations when applying it in a clinical trial? 

If yes, click below on the solutions to learn more.

Operational Complexity Assessment Tool (O-CAT)

Are you looking for a tool to help assess operational complexity before implementing a particular modern solution in a clinical trial?

The Operational Complexity Assessment Tool 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.

Assessing operational complexity before implementing a solution will help a sponsor to identify areas that may increase the complexity of implementation and give the sponsor some ability to develop strategies to reduce or mitigate the complexity. This ability to mitigate can prove invaluable, especially in situations in which the circumstances or patient welfare dictate that the sponsor implements the solution, such as during the pandemic. Organizations may use the tool to help assess operational complexity before implementing a particular solution. A need exists for the O-CAT because clinical trial sponsors frequently decide to use highly complex solutions because they may be the best approaches for patients.

This tool focuses only on one factor, operational complexity. A user is free to add additional columns to the tool to address other factors that may contribute to or help resolve implementation challenges, e.g., budget considerations. The user will need to decide not only how the degree of complexity (as indicated by O-CAT) could affect a company’s implementation, but how other factors might also impact implementation.

Download the Operational Complexity Assessment Tool (O-CAT).

Process Frameworks

Has your organization already decided to implement one or more modern solutions but is looking for considerations when applying it in a clinical trial? 

The Process Frameworks outline various considerations, from trial planning to study closeout, that sponsors may wish to think about when implementing selected modern solutions. It is important to note that whether and to what extent a solution may be deemed patient-centric will vary depending on the particular circumstances. Only by considering patient needs, preferences, and other factors, can a sponsor decide what the right approach is for a particular trial.

MODERN SOLUTIONSOLUTION DOWNLOAD
Digital Data Collection ToolsDigital Data Collection Tools Process Framework
Direct-to-Patient ShippingDirect-to-Patient Shipping Process Framework
Electronic Informed ConsentElectronic Informed Consent Process Framework
Home Health VisitsHome Health Visits Process Framework
Local Community-Based FacilitiesLocal Community-Based Facilities Process Framework
Remote Site MonitoringRemote Site Monitoring Process Framework
TelemedicineTelemedicine Process Framework