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 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.

TransCelerate strives to foster innovation and transform clinical trial execution to ensure patients in clinical trials have the best possible experience, while also helping the R&D ecosystem speed up the time to market for new products and medicines.

An example of this innovative work was TransCelerate’s response to the novel COVID-19 pandemic. By creating a forum where member companies could share knowledge on how to ensure trial continuity in a stay-at-home environment, TransCelerate not only helped member companies keep their clinical trials active, but they also enabled discoveries about how alternative trial approaches could offer better patient experiences in clinical trials moving forward.

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.

The work entailed the team engaging in discussion with stakeholders from across the R&D ecosystem and made it clear that transforming the patient experience for clinical trials is dependent on factors both internal and external to the healthcare ecosystem. This further reinforces the need for the ecosystem to continue transparent and open collaboration with different stakeholder groups. This Clinical Trials in 2031 and Beyond report can help the ecosystem understand some of the diverse drivers that influence the future of clinical trials. With that, it enables stakeholders in the ecosystem to prepare for potential scenarios to ensure patient-centric clinical trials in the future.

Furthermore, the drivers identified in the Clinical Trials in 2031 and Beyond report helped to reinforce areas of opportunity for TransCelerate to lead the transformation of clinical trials to be more patient-centric. TransCelerate acknowledges major drivers influencing the future of clinical trials including the ecosystem’s attitude and behavior towards data sharing and the willingness, trust, and ability for individuals to participate in trials. TransCelerate is committed to the positive evolution of major drivers like these through strategic initiatives working to improve participant data return, the enrollment of diverse populations, clinical trial accessibility and personalized participation experiences.

Thought Leadership
Resource NameDescription
Clinical Trials in 2031 and BeyondReport that utilizes a scenario planning exercise to explore the potential drivers influencing the future of clinical trials. Building on input from diverse thought leaders in the healthcare ecosystem, it further organizes the identified drivers into a matrix, which can be utilized to explore how combinations of the drivers might impact clinical trials in the future. To aid the thought process, the MCTC team has identified four potential future scenarios of clinical trials and outlined the characteristics of each scenario.
MCTC Beyond COVID-19A paper highlighting the continuity solutions implemented during the pandemic.
Participant Data Return
Resource NameDescription
Participant Data Return Resource PackA document that provides access to a consolidated set of resources from within the clinical research ecosystem that can assist with returning individual data globally.
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
Additional Resources
Resource NameDescription
Continuity Solution Case StudiesPresentation of five case studies of continuity solutions implemented during the COVID-19 pandemic.  Case study information includes a description of the continuity solution, different to traditional models, challenges and success factors.
MCTC Workshop FindingsWrite up of workshop findings from sessions held in 2020 to further understand the root cause of why industry hasn’t already moved towards modernized clinical trial conduct, define the successful use of modernized clinical trials solutions and associated requirements, and explore how to transition to using these solutions at-scale and the scenarios where they are most appropriate.
Pre-COVID-19 RBM SDV/SDR Pandemic PracticesA summary of key findings from a voluntary 2020 survey conducted in TransCelerate Member companies pre-COVID, regarding their Risk Based Monitoring (RBM) practices related to Source Data Verification (SDV) and Source Data Review (SDR).