After a year of disruption, Covid-19 has accelerated the uptake of decentralised clinical trials (DCTs).
At last week’s OCT West Coast virtual conference, GlobalData’s global director for databases and analytics Revati Tatake presented the results of a GlobalData survey with 150 respondents holding a variety of industry roles to discover what they thought was in the future for DCTs.
Respondents came from contract research organisations (CROs), contract manufacturing organisations (CMOs), clinical investigators, pharma and biotech companies as well academic and government organisations.
The trend towards DCTs
57% of the survey’s respondents predicted that DCTs will be more frequently used in the next two years, while 26% believed it will take three to four years for DCTs to become more commonplace. One third of the survey respondents have already been using DCT methods.
The majority of organisations believed that DCTs would be more frequently used in the next two years. Importantly among the most likely respondents to hold this view were government and academic institutions, CROs and other contract service providers.
The graph below shows what respondents who had not used DCTs previously saw as the top perceived benefits.
The top advantage was greater accrual of patients for trials, followed by increased participation of sites. These top two benefits suggest that the future move to DCTs will be due to the need to improve enrolment numbers rather than the specific threat of Covid-19 impacting trials.
Challenges of moving to DCT models
Looking at the challenges involved in moving towards DCTs, the number one challenge reported by survey respondents were changes to required procedures and processes, as well as systems integration. Finding and validating technology vendors to start without causing delays to trial initiation may also be a potential challenge.
The next most common concern is unclear regulatory acceptance or guidance. Revati noted that tracking changing regulatory guidance will be key to adapting trials in the post-pandemic environment.
“The regulators are listening now more than ever,” said Tatake. “The FDA in the US is being very flexible, but the policies on new ways to collect data vary by country. In the EU some countries allow centralised monitoring of clinical trials as long as patient confidentiality is maintained.”
GlobalData analysed responses for the changes needed to pivot to decentralised clinical trials. The top required changes reported by respondents were in system integrations and alignment.
This is followed closely by process changes and alignment, as well as training.
The fact that all of the responses ranked so closely indicates that there are many perceived changes that are need to make a convincing transition to DCTs.
Emerging tech in clinical trials
Finally, GlobalData analysed the uptake of emerging technologies as a result of Covid-19. As shown in the chart below, most respondents believed that remote patient monitoring (RPM) via telemedicine will become the most common technology even after the pandemic.
“RPM can enable healthcare providers to get data-driven insights, help deliver patient-centric treatment and disease management approaches,” said Tatake. “From a clinical trials perspective it can provide remote monitoring options or outcome measures in DCTs.”
The chart also shows that a shift to DCTs was deemed the second most emerging change post-pandemic by the respondents across multiple regions globally.
Click here to find out more about Covid-19’s impact on clinical trials from Revati Tatake’s presentation at OCT West Coast.