- Making sure sites are well prepared will be paramount to success
Site readiness is a factor that will drive the successful implementation of decentralized components. Despite the time savings that may result from the reduction in on-site visits, additional complexities are generated by the new technologies, the training requirements, and the evolution of site infrastructure.
Improving training material, site support, and technical infrastructure will be necessary for site staff to fully adopt clinical trial digitalization that is embedded within decentralization.
- Being aware of regulatory evolution is necessary to implement decentralized clinical trials globally
Until recently, there was little regulation to help the implementation of remote components to clinical trials. As not all regulatory agencies evolve in the same way or at the same pace, launching DCTs in a wide range of countries will be complex. Teams will have to adapt their DCT strategy according to the national laws of the countries where the trial is planned, and will necessarily proceed through close monitoring of regulatory developments.
Data security and privacy concerns will also have to be discussed with study teams and safeguards must be in place.
- Using a single platform will simplify data aggregation and increase user-friendliness
Decentralizing clinical trials means enhancing the ability of participants to access a trial, regardless of their physical proximity to the trial center. Many, although not all, aspects of decentralization will include significant integration of different digital systems. Proposing open platforms that allow the integration of technologies is key to broadening the spectrum of digital trials to several data sources while maintaining easy-to-use solutions for sites and participants.
— When planning trials, it will become increasingly important to integrate up-to-date understanding of technology. The decision whether to use specific digital tools such as eCOA, telemedicine or eConsent can influence aspects of the trial, including timelines, recruitment strategies, types of data collected, and training that may be required for research teams and participants.
— When it comes to building the systems, layering technical components risks complicating data aggregation and system utilization. As patients and sites log into the system, having multiple devices, apps and credentials to access different services would be counterproductive, and would have an adverse impact on their experience of digital clinical trials. Inversely, creating open platforms that are flexible for the integration of different systems will simplify data analysis and at the same time, using a single sign on to access several services, immediately have a positive impact on the user’s experience. It will also make the clinical trial more attractive to patient populations that are less technology-aware and as such help to expand diversity in clinical trials.
As not all systems can be built, product developers should consider both developing in-house expertise and integrating partner technologies. In this way, specialized areas of relevant experience and expertise will be brought together, and additionally systems will become sufficiently integrated into a single platform for the benefit of all clinical trials stakeholders.