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.

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.