The Association of Clinical Research Organizations (ACRO) released its DCT Toolkit, which lays out a vision for how decentralised clinical trials (DCTs) 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. DCTs have been an innovative resource during the pandemic, which ACRO believe will continue to be an important, patient-centric clinical trial design.
The DCT Toolkit is now available to download on ACRO’s website and contains four resources:
1. Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralised Clinical Trials
2. QbD Manual for Decentralised Clinical Trials: The Quick Reference Guide
3. Decentralised Clinical Trials Risk Assessment Considerations
4. Decentralised Clinical Trials Data Flow Maps
“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.”