When the COVID-19 pandemic made in-person clinical research visits difficult, if not impossible, CROs and technology companies were able to keep active clinical trials up and running, often by using remote technologies – telemedicine, remote sensors, wearable devices – to allow patients to continue to get the care and evaluation that are part of a clinical trial. Decentralized trials (DCTs) have been a valuable resource during the pandemic, and DCTs will continue to be an important, patient-centric trial design.
The DCT Toolkit
ACRO’s Decentralized Clinical Trials Working Party has created a Toolkit that lays out a vision for the planning and execution of DCTs. The toolkit consists of four resources:
Bringing the Trial to the Patient: A Quality-by-Design Manual for Decentralized Clinical Trials
The Quality-by-Design Manual for DCTs is a comprehensive framework focused on the construction of decentralized clinical trials – from early design and planning to close and archiving. Many of the beginning-to-end steps in the clinical trial process are addressed in the same way under both a “conventional” and a “decentralized” trial model. However, there are some steps in the clinical trial process where a decentralized model raises new and unique questions. The Manual applies a QbD framework to those clinical trial steps where new issues emerge when a DCT model is adopted.
QbD Manual for Decentralized Clinical Trials: The Quick Reference Guide
The QbD Manual Quick Reference Guide was created to provide a more readily accessible version of the full-length ACRO DCT QbD Manual.
Decentralized Clinical Trials Risk Assessment Considerations
The DCT Risk Assessment Considerations is a template designed to systematically generate questions that facilitate cross-functional discussion in order to identify and mitigate potential risk in decentralizing trial functions. This worksheet is intended to complement (and be used in conjunction with) a company’s existing risk tools.
Decentralized Clinical Trials Data Flow Maps
Data integrity and data quality are key pillars of clinical research. The ACRO DCT Data Flow Maps are designed to build confidence and trust in decentralized clinical trials by providing transparency and visibility into data flow, data controls, and data traceability within a DCT to illustrate how a decentralized model guards data quality and integrity.
ACRO members are invited to download these tools and encourage colleagues, customers, and other stakeholders to do the same.
Sample Social Media
[Twitter] Decentralized Trials have been a valuable resource during the pandemic and will continue to be moving forward. Check out ACRO’s latest DCT Toolkit to see how such Decentralized #ClinicalTrials can be planned and executed now and in the future: https://www.acrohealth.org/dctoolkit/
[LinkedIn] The ACRO DCT Toolkit lays out a vision for how Decentralized #ClinicalTrials can be planned and executed now and in the future. Dive into the four resources designed by ACRO and use the tools to navigate #DCT design: https://www.acrohealth.org/dctoolkit/
[Facebook] When the COVID-19 pandemic made in-person clinical research visits difficult, if not impossible, Decentralized Trials became a valuable resource. The ACRO DCT Toolkit lays out a vision for how such Decentralized #ClinicalTrials can be planned and executed now and in the future: https://www.acrohealth.org/dctoolkit/
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