Decentralized Clinical Trials
In October 2019, ACRO established the Decentralized Clinical Trials Working Party to examine the barriers to adoption of DCTs and create quality-based principles and tools to facilitate implementation of decentralized clinical trials.
Thought Leadership on DCTs
ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. In addition to the DCT Toolkit, ACRO’s White Paper provides an overview of key issues in the decentralization of clinical trials.
ACRO Expands DCT Toolkit with a Fifth Resource
Stakeholders are experiencing a paradigm shift in the clinical trial enterprise from conventional trials to studies where at least one or more DCT components are utilized (e.g., direct-to-patient shipment and home health visits). The use of DCT components is here to stay, and stakeholders need the tools to successfully embrace this change. While the Quality-by-Design (QbD) Manual, Risk Considerations Tool, and Data Flow Maps focus on providing educational resources to build confidence and trust in DCTs, this new ACRO resource focuses on the final hurdle to greater DCT adoption – which is the change management needed to address risk aversion and the difficulty in adopting brand new ways of working. Access the latest toolkit resource here.
The Complete ACRO DCT Toolkit – Additional Resources
- Navigating Change During Rapid Transformation: A Q&A Resource for Decentralized Clinical Trials
- ACRO DCT White Paper: A New Quality-by-Design, Risk-Based Framework
- Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials
- QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide
- Decentralized Clinical Trials Risk Assessment Considerations
- Decentralized Clinical Trials Data Flow Maps
ACRO members are dedicated to helping bring quality-based principles, risk-assessment tools, and patient-centricity to the decentralized trials process.
Explore some of ACRO’s additional DCT resources: