Industry group ACRO says regulators still have concerns about data quality in centralized trials despite backing the approach.
The number of decentralized trials being run by CROs has increased markedly over the past year according to ACRO, which cited the coronavirus pandemic as a major factor in the increased popularity of such studies.
“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,” the US-based industry group said.
And – ACRO said – in general, drug regulators have welcomed the approach, albeit with some reservations.
“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.”
To try and address these concerns ACRO has developed a decentralized trials toolkit for contractors and study sponsors.
The idea is to provide CRO with quality-by-design based trial design advice as well as explaining how they should risk assess decentralized studies to prevent potential disruption or problems with data.
Data flow
The toolkit also provides what ACRO calls “data flow maps” that cover data integrity issues.
Jackie Kent, Chief Customer Officer at Medidata and Vice-Chair of the ACRO Board of Directors, said “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.”
This was echoed by Jim Streeter, Global Vice President of Product Strategy at Oracle Life Sciences and member of the ACRO DCT Working Party, who emphasized the clarity of the approach.
“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.”
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