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September 1, 2020

ACRO releases report on risk-based framework approach within decentralised trials

Activities of clinical studies have been traditionally cantered around trial sites where participants travel for enrolment.

Activities of clinical studies have been traditionally centred around trial sites where participants travel for enrolment.

This approach is either time-consuming or can place a cost burden on patients, creating an inconvenience. This further leads to a limit in enrolment speed and trial completion.

In order to ‘transcend’ these limitations, clinical researchers are in the process of exploring new ways to identify emerging mobile technologies, as well as increased connectivity within decentralised clinical trials.

Realising the importance of mitigating uncertainty around creating and implementing decentralised clinical trials (DCTs), the Association of Clinical Research Organizations (ACRO) and its member company Decentralized Clinical Trials Working Party have released tools that outline the best practices of the industry.

ACRO Global Regulatory Policy senior vice-president said Karen Noonan said: “We are very pleased to issue ACRO’s white paper ‘Decentralizing Clinical Trials: A New Quality-by-Design, Risk-Based Framework’.

“The paper and the accompanying toolkit provide a set of operational best practices for the implementation of decentralised clinical trials that will be helpful to sponsors and research organisations as we increasingly see technology-enabled trials that reduce burdens on patients and research sites alike.”

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The toolkit comprises a ‘Quality-by-Design Manual’ for bringing the trial to the patient and a DCT risk assessment considerations spreadsheet to complement organisations’ current risk assessment tools.

ACRO Board Chair Alistair Macdonald said: “Decentralised trials have provided the pathway, where appropriate, to continue to service patients and to keep trials up and running despite site access limitations during the pandemic.

“ACRO members were able to quickly adapt by using innovative DCT tools to collect patient data during this time, including remote monitoring techniques, telemedicine and the use of remote and wearable devices”.

In May last year, ACRO in the US called for the adoption of risk-based monitoring (RBM) of clinical trials to ensure safer, efficient and quality studies.

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