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Modernizing Clinical Trial Conduct

The Modernizing Clinical Trial Conduct (MCTC) initiative focuses on helping sponsors and other stakeholders evolve how trials are designed and conducted, supporting efforts to blend patient-friendly decentralized methods with traditional methods to make participation more accessible and flexible.

By helping to reduce logistical barriers and expanding patient options, MCTC seeks to enable an environment that can deliver more inclusive research experiences while preserving the integrity of trial data and participant safety.

Overview

The COVID-19 pandemic challenged the clinical research ecosystem in far-reaching ways. During that period, decentralized methods, such as telemedicine, electronic informed consent and home medication delivery, emerged as practical solutions to maintain trial continuity. These approaches also highlighted new opportunities to improve how trials are designed and experienced.

The MCTC initiative was developed to support broader adoption of these methods where appropriate. It provided tools that help sponsors explore trial complexity, plan for flexible delivery models and gather input from patients and sites. When thoughtfully applied, these resources may help reduce site burden, enhance participant engagement and offer additional options for how patients take part in research.

By supporting efforts to embed these modern methods into the fabric of clinical research, MCTC helps bring trials closer to patients—and brings us closer to a future where studies are more inclusive, efficient and responsive to real-world needs.

Solutions and Resources

Explore a suite of resources designed to support more flexible, patient-centered clinical trials, from early planning through closeout. These tools and frameworks help sponsors evaluate complexity, plan decentralized elements and incorporate feedback from patients and sites.

Toolkit

Decentralized Clinical Trial (DCT) Considerations, Patient Protocol Engagement Toolkit (P-PET) Resource Guide Addendum

An addendum to the P-PET with additional consideration for engaging patients and caregivers in decentralized clinical trials. All materials related to the P-PET, including the DCT Considerations Addendum, can be found on the Patient Experience webpage.

7.94 MB

Digital Tool

Operational Complexity Assessment Tool (O-CAT)

An interactive tool to help sponsors assess potential challenges in implementing modern solutions and identify ways to reduce complexity.

0.29 MB

Framework

Process Frameworks

Proposed considerations for planning and executing decentralized trial components, including: Digital Data Collection Tools, Direct-to-Patient Shipping, Electronic Informed Consent, Home Health Visits, Local Community-Based Facilities, Remote Site Monitoring, Telemedicine

44.96 MB

Framework

Points to Consider for DCT Capability Support

Points to consider (based on site and service provider engagements) are designed to support sponsors in their efforts to collaborate with service providers and improve the overall experience and engagement of site staff and patients with decentralized clinical trial elements.

0.34 MB

Toolkit

Decentralized Clinical Trial (DCT) Considerations, Study Participant Feedback Questionnaire (SPFQ) Question Bank Addendum

An addendum to the SPFQ to support the efforts of trial sponsors to gather patient feedback during clinical studies with the implementation of decentralized clinical trial elements. All material related to the SPFQ, including the DCT Considerations Addendum, can be found on the Patient Experience webpage.

0.09 MB

Survey Result

Sponsor Experience Implementing Decentralized Clinical Trial (DCT) Elements: DCT Implementation Survey Results

A summary of insights from TransCelerate member companies on their experiences implementing decentralized clinical trial elements post-pandemic, including challenges, success factors and lessons learned.

0.41 MB

Survey Result

Maturity Survey Detailed Report

Aggregated and blinded findings from a member survey on the adoption and deployment of modern trial solutions.

1.05 MB

Case Study

Continuity Solution Case Studies

Five examples of continuity solutions used during the COVID-19 pandemic, highlighting key challenges, adaptations and takeaways.

0.46 MB

White Paper

Beyond COVID-19: Modernizing Clinical Trial Conduct

A paper exploring how pandemic-era adaptations can inform long-term transformation of trial models.

0.41 MB

Guide

Sponsor Considerations for Obtaining Site Feedback

A set of considerations to support sponsors obtaining site feedback, including DCT experience. It proposes a selection of potential feedback mechanisms and a sample question bank.

0.55 MB

White Paper

Clinical Trials 2031 and Beyond Report

A scenario planning exercise that outlines potential drivers that could influence the future of clinical trials and how varying these drivers could shape the landscape.

1.36 MB

Guide

Pre-COVID-19 RBM SDV/SDR Pandemic Practices

A summary of key findings from a TransCelerate member company survey regarding practical experiences with various risk-based monitoring practices related to source data verification and source data review.

1.66 MB

Workshop Finding

MCTC Workshop Findings

Key takeaways from stakeholder workshops focused on identifying barriers to adopting modern clinical trial elements and strategies for scalable implementation.

0.22 MB

Media and Webinars

Members of the MCTC workstream have shared perspectives on decentralized trial implementation in various industry forums. This includes participation in Applied Clinical Trials and appearances such as DTRA’s TGIF podcast.

'Fit-for-Purpose' Considerations for Remote Trials

Article

The Decentralized Trials & Research Podcast

Podcast

Implementation Experiences

O-CAT Helps Study Team Package Key Endpoints to Reduce Patient Burden

2 min read

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