Exom implements a digital application in every clinical trial. This is a virtual assistant that shows the investigator all the activities planned by the trial protocol that he must carry out.
Digital assistants are identified by many names: chatbot, virtual assistant, conversation tool, to name a few. They are found in different devices (mobile phones, smart speakers), platforms (applications, web) and environments (cars, homes). These are conversation-based interfaces that people use by typing, speaking or both. Regardless of what we call them or how we interact with them, digital assistants are becoming increasingly common in our lives.
As a human assistant, the purpose of a digital assistant is to make life easier and more enjoyable. How’s that? Efficiently completing the tasks of everyday life and freeing up time for more efficient work or more enjoyable activities.
Complexity and timing of a clinical study
The Tufts Centre for the study of drug development (Csdd) recently conducted a study that examined the impact of protocol design on the clinical trial complexity. The results indicate that, in recent years, the median number of procedures per clinical trial has increased by 49%, while the total effort required to complete these procedures has increased by 54%.
The success or failure of multi-centers clinical trials depends largely on the commitment of the individual investigators involved, who unfortunately have to manage multiple activities ranging from identifying patients, discussing their participation in the trials, screening, conducting specific study visits and entering data in the eCRF, participating in monitoring visits, and finally in notifying and following-up adverse events.
Investigators are also regularly held responsible for recruitment challenges, although they did not play an active role in the development of the study protocol. These experiences can be exacerbated by the stress that they feels linked to the pressure for the respect of the various timelines.
Digital Assistants, The Genius EVA Case by Exom Group
With the aim of helping the team responsible for managing the study, Exom Group, the global digital CRO, implements a digital application in every clinical trial. It is called Genius EVA (Exom Virtual Assistant) that, with a real time update, through an interface accessible either from the study portal or directly from the mobile phone, highlights to the investigator all the activities planned by the trial protocol that must perform in relation to the patients of his center.
Genius EVA also calculates the days of delay with respect to the scheduled date for completion of the specific activity, highlighting in orange and then in red those whose delay has exceeded a range considered physiological (orange) or worrying (red).
Without having to exit the application, the investigator, with a simple click, can reach that section, form or file where he has to do the operation still pending. There are several quality and performance parameters that are monitored by Genius EVA and that can be defined and monitored according to the type of study.
Also through the application, the doctor can follow the progress of the recruitment of the study, in general, by country and its center, check the dates of future visits of patients of which he is then informed by email, sent a few days before.
Obviously the digital assistant does not intend to replace the direct interaction between the doctor of the center and the clinical monitor of the CRO, but on the contrary, it facilitates the connection, providing the possibility for the investigator to send to the monitor directly from the application, a communication or to make a video call.
Digital assistants, the advantages of Genius EVA
The implementation of Genius EVA in some multicenter clinical studies, including international ones, has had a highly positive impact both on the quality of the data and on the performance of the centers.
For example, the median delay between the date of the visit and the data entry in eCRF has been reduced from about 28 days to less than 10 days thanks to the activation of Genius EVA. Equally significant reductions in execution times have been recorded in many other activities, including those carried out by the center’s monitor, with a general improvement and speeding up of monitoring and data management processes.
Currently, the incentives for an investigator to invest time and effort in participating in a clinical trial (beyond the desire to participate in a scientific project) are relatively limited, despite the fact that such participation gives him access to new technologies, devices and drugs that can improve and promote local clinical practice.
In order to be able to cope with an ever-increasing procedural complexity and with the stringent regulatory obligations, he needs a constantly updated and available assistance that simplifies his work as an investigator, showing him what to do and making available to him all the information available.
With Genius EVA, the digital assistant who is now present in our mobile phones, in our homes and in our cars also enters clinical research. Once again, the digital revolution is making a further contribution to the process of improving and modernising clinical trials.