The COVID-19 pandemic has triggered several changes in the pharmaceutical sector across the world with several companies adopting decentralised clinical trials (DCTs) to minimise disruptions.

GlobalData conducted a survey to identify the biggest challenges of decentralised/ virtual trials.

Biggest challenges with decentralised clinical trialsBiggest Challenges Facing Decentralised Clinical Trials

The survey found that the changes required to procedures, processes, and/or systems while conducting DCTs emerged as the biggest challenge for the industry.

A total of 21% of the respondents expect that the implementation of such changes will be the number one challenge while transitioning to DCTs.

Unclear regulatory acceptance was the second biggest concern with 16% of the respondents highlighting the challenges of tracking the changes in regulatory guidance while conducting decentralised trials.

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It was followed by the concerns regarding the ability of the investigators to perform their regulatory duty (11%) and overall quality of the study data (9%).

Around 8% of the respondents highlighted lack of data integration, while another 8% opined additional complexities to be a user of study related systems was the biggest challenge for DCTs.

Change of management, more complexities to be a study site and investigators performing system validation was viewed as the biggest challenge by 6%, 5% and 5% of the respondents, respectively.

Risks of cost increase (4%), safety of patients (4%) and the need for additional study site personnel to conduct a study (2%) also concerned the industry.

The remaining 1% of the respondents highlighted other challenges.

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.