The transition to decentralised clinical trials (DCTs) due to COVID-19 outbreak has triggered several challenges for all organisations.

GlobalData conducted a survey to identify the biggest concerns of the industry as they switch to decentralised/ virtual trials due to restrictions amid the pandemic.

Changes in processes emerge as biggest concern for conducting decentralised clinical trialsBiggest Challenges Facing Decentralised Clinical Trials by Company Role

An analysis of the survey results show that changes required to procedures, processes, and/or systems has emerged as the biggest concern for nearly all organisational groups.

Around 24% of other contract service providers opined that such changes are the biggest challenge for them. Approximately 23% of contract research organisations (CROs), 21% of pharma/ biotech, 18% of clinical/ investigator site and 7% of government/ academic institute shared the same concern.

Unclear regulatory practice is another top concern for the industry with 20% of pharma/ biotech, 16% of CROs, 13% of other contract service providers, 9% of clinical/ investigator site and 7% of government/ academic institute voting for it.

Ability of the investigators to perform their regulatory duty is the biggest concern for clinical/ investigator sites (18%). It is followed by other contract service providers (12%), CROs (10%), pharma/ biotech (9%) and government/ academic institute (7%).

The group of government/ academic institutes (14%) leads in the concern for overall quality of the study data. It is followed by pharma/ biotech (12%), clinical/ investigator sites (9%), other contract service providers (7%) and CROs (6%).

The government/ academic institutes also lead in the concern for investigators performing system validation and in the anticipation that more study site personnel will be needed to conduct a study.

Around 14% of the respondents from both the groups of clinical/ investigator sites and government/ academic institutes feel that lack of data integration will be the biggest challenge.

Similarly, around 12% of other contract service providers opined that it will be more complex to be a user of study related systems.

Change of management, risks of funding and cost increase, complexities to be a study site and safety of the patients were other key concerns expressed by the organisational groups.

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.