ACRO adds to DCT toolkit to help drug firms prep for remote studies

ACRO has added a “change management resource” to its recently launched decentralized study toolkit for drug makers considering remote studies.

The industry group announced the expansion in October, explaining the change management tool takes a question-and-answer approach to potential sources of stakeholder hesitance regarding DCTs to facilitate greater adoption.

The idea - according to ACRO member Jim Streeter, who is global vice president of life science customer success at Oracle - is to ensure drug makers are comfortable when switching from traditional models to the decentralized approach.

“The industry has evolved to offer increasingly sophisticated tools and controls to help protect patient safety and safeguard data integrity in decentralized trials. Yet, expanded adoption of DCTs is impossible if stakeholders are not ready and comfortable in embracing this paradigm shift in clinical research.

“It has been a pleasure to be part of the ACRO committee that developed this new tool. We hope it will help enable the kind of change management that is needed for stakeholders to embrace the use of DCTs.”

This view is shared by Allyson Small, chief operating officer of the Society for Clinical Research Sites (SCRS), who said “change management is not easy, and the work required for stakeholders to feel comfortable with change is just beginning.

“We congratulate ACRO on creating this new tool for stakeholders, and we look forward to continued conversation with ACRO on change management and other efforts to advance DCTs.”

ACRO launched its decentralized trial toolkit last year, initially framing it as a set of tools and ideas that drug developers can use to secure data generated during non-site based drug research programs.

Expansion of the toolkit is timely. In September, analysis by the Tufts Center for the Study of Drug Development (Tufts CSDD) suggested decentralized trials increase the value of drug candidates.

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