European Trials Lag Behind U.S. in Decentralization, Survey Finds
European pharma/biotech and medical device companies have not moved as rapidly to adopt decentralized and virtual trial approaches as their U.S. counterparts, but they recognize the potential of such methods and plan widespread use of them over the next three years, a new survey shows.
The just released survey, conducted by trial advisory firms Climedo Health and Curedatis, paints a stark picture of decentralized and virtual trial use by European pharma/biotech and medtech firms since the technology was brought to the forefront by COVID-19: a strong majority (79 percent) of the 60 respondents said that they still haven’t conducted any decentralized or virtual trials.
By contrast, WCG Avoca’s June 2021 state of the industry report, which includes a survey of sponsor and provider respondents mainly based in the U.S., found that around half reported using decentralized trial activities and 40 percent or more reported adopting decentralized approaches during the pandemic. Nearly all said that they would continue using pandemic-era innovations they had incorporated, at least under some circumstances (CenterWatch Weekly, June 21).
The gap between U.S. and European trials’ use of decentralized methods may narrow in the coming years, as the Climedo/Curedatis survey reports more than two-thirds of the surveyed European companies indicated they intend to move toward decentralization in the next three years.
Almost three-quarters (74 percent) of respondents, which ranged from small- to large-scale manufacturers, consulting firms and CROs/service providers, cited digital technologies as something they need to simplify the clinical trial process. A similar percentage said they need better communication with study centers to make their trials simpler, while approximately 60 percent said regulators need to be clearer about clinical trial requirements.
Pharma/biotech companies responding to the survey appeared more hopeful and enthusiastic about the potential of adopting digital technologies that will enable decentralization than the medtech firms surveyed.
Those European companies that did implement decentralized methods reported serious benefits: 75 percent said they saw cost savings, 70 percent saw their studies move faster and half said patient recruitment was made easier.
Asked what they thought would be the most defining trial trends over the next three years, 89 percent of respondents named minimal on-site monitoring through integration of electronic case report forms (eCRF) into the electronic patient record. Coming in second, a little more than half named decentralized/virtual trials, while around 45 percent predicted a high use of wearables in trials.
The survey also questioned companies on the biggest challenges they face throughout each stage of their trials (planning, implementation and closeout) and how they thought they could overcome them. Notably, digital technologies were named at every phase.
“The challenges in clinical studies are manifold and, depending on the phase, they range from a lack of personnel, high costs, patient recruitment and time requirements, to more difficult data analysis and publication,” said Veronika Schweighart, cofounder and chief operating officer of Climedo Health. “But when asked about a potential solution to overcome these hurdles, we see one recurrent theme: digital technologies. These were cited as an opportunity by the majority of respondents in every phase.”
Respondents also ranked various aspects of trial management by level of digitalization potential. In the trial planning phase, feasibility analysis, communicating with authorities and patient recruitment were all ranked similarly as having moderate potential, while site identification and study design appeared lower on the scale.
For trial implementation, companies felt data capture, patient communications and monitoring held great potential. Patient compliance, retention and motivation and patient recruitment were also ranked as having fairly high prospects.
In the trial closeout phase, data management was named as the area with the greatest promise for digitalization, followed by data export, statistical analysis and database freeze, all of which were ranked fairly high. Final reporting and publication were scored noticeably lower.
Access the full report here: https://bit.ly/38yeu42.