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March 11, 2021

Key changes needed for transition to decentralised clinical trials by company role: Survey

The pharmaceutical industry anticipates significant changes while transitioning to decentralised clinical trials (DCTs) amid the pandemic.

The pharmaceutical industry anticipates significant changes while transitioning to decentralised clinical trials (DCTs) amid the pandemic.

GlobalData conducted a survey on different organisations associated with the industry to identify the key aspects of studies that will be required to change while switching to DCTs.

Key changes needed for transition to decentralised clinical trials by company roleBiggest Changes Needed to Pivot to Decentralised Clinical Trials by Company Role

An analysis of the survey found that systems integrations and alignment, and process changes and alignment are the top two changes that the respondents feel are required to transition from conventional trials to DCTs.

Around 19% of CROs and clinical/ investigator sites each opined that systems integrations and alignment will be the biggest change. The figure stands at 17% for other contract service providers, 16% for pharma/ biotech and government/ academic institutes.

The percentage of respondents who voted for process changes and alignment are 18% for other contract service providers, 18% for government/ academic institutes, 16% for CROs, 15% for pharma/ biotech and 14% for clinical/ investigator sites.

Approximately 18% of CROs highlighted changes in training will be needed to pivot to DCTs. The percentage stands at 16% for pharma/ biotech, 14% for other contract service providers, 14% for clinical/ investigator sites and 11% for government/ academic institutes.

Similarly, around 18% of pharma/ biotech and government/ academic institutes opined that changes in regulatory/ operational risk assessments will be needed for transition, a view shared by 16% of clinical/ investigator site respondents and 13% of respondents in other two groups.

The percentage of respondents who felt changes in upfront planning and coordination for study execution will be the key stand at 16% for clinical/ investigator sites, 14% for CROs and 13% for other three groups.

Around 16% of government/ academic institutes believe that adjustments in study design will be required. The figure drops to 14% for pharma/ biotech, 12% for clinical/ investigator sites and 13% for the two other groups.

Changes in organisation structure was the least voted among all, with 12% of other contract service providers aligning with the view. The figure further declines to 10% for clinical/ investigator sites and pharma/ biotech, 8% for government/ academic institutes and 7% for CROs.

The analysis is based on responses received for the Coronavirus Survey – COVID-19 and Decentralised Clinical Trials conducted by GlobalData between 04 June and 22 June 2020.

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