Today, ACRO released its DCT Toolkit, which lays out a vision for how decentralized clinical trials can be planned and executed now and in the future.
When COVID-19 hit in March 2020, clinical trial participants were cut off from in-person clinical research visits. CROs and technology companies were often able to keep active clinical trials up and running by using remote technologies – telemedicine, remote sensors, wearable devices. This allowed patients to continue to get the clinical care and medical evaluation that are part of a clinical trial. Decentralized clinical trials (DCTs) have been an innovative resource during the pandemic, and DCTs will continue to be an important, patient-centric clinical trial design.
The DCT Toolkit is now available on ACRO’s website and contains four resources:
- 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
Regulators around the world have shown real flexibility on encouraging the use of remote technologies that help to bring the clinical trial closer to the patient. At the same time, they understandably express concern about the quality and integrity of the data as trials are decentralized.
“With the DCT Data Flow Maps project, ACRO’s Decentralized Clinical Trials Working Party aims to provide transparency and clarity on the processes for keeping data secure, confidential, and accurate,” said Jackie Kent, Chief Customer Officer at Medidata and Vice-Chair of the ACRO Board of Directors.
Jim Streeter, Global Vice President of Product Strategy at Oracle Life Sciences and member of the ACRO DCT Working Party commented: “The Data Flow Maps take a highly visual approach to explaining the ways in which the DCT model guards data integrity and quality. We hope this map-like illustration of data flow will be particularly useful to regulators, customers, and stakeholders.”
For further comment or press inquiries, please contact Karen Noonan, ACRO Senior Vice President of Global Regulatory Policy, at [email protected].
About ACRO
The Association of Clinical Research Organizations (ACRO) represents clinical research and technology companies that provide a variety of specialized services to support the development of new pharmaceuticals, biologics, and medical devices. Through its member companies, ACRO helps improve the quality, efficiency, and safety of biomedical research. ACRO member companies operate in more than 100 countries across the globe and conduct or support the conduct of the majority of clinical trials worldwide.