Genius ROSA (Remote Omnichannel Study Assistance) is a multi-channel application designed for direct communication between doctor and patient and for remote monitoring of their clinical conditions during a clinical trial.
An important part of the progress of medical research and drug development is to make patient participation in clinical trials easier and more inclusive. To develop treatments that work on men, women and children of all ages and different ethnicities, and in the actual conditions of future use of the therapy, we need both to have clinical
data that represent the diversity of the population, and to measure the various parameters of treatment effectiveness and tolerability when the patient is in the environment in which he normally lives.
Telemedicine, the importance of reliable data
The lack of diversity in clinical trials has widespread implications. Most of the cancer drugs used today are developed on the basis of clinical data that are representative of less than 5% of cancer patients. In both Europe and the United States, ethnic or racial minorities are very widespread and represented, but patients participating in clinical trials for new drugs are in some cases strongly white, from 80 to 90 percent.
Clinical conditions such as heart disease, cancer, and diabetes, as well as therapeutic responses, vary by ethnicity, as well as between the sexes. If different groups of patients are not part of these studies, we cannot be sure if the treatment will work in all populations or what side effects might emerge in one group or another.
Technological solutions such as telemedicine, which reduce the obstacles and burden of participation in clinical trials, together with the availability of devices that allow various clinical parameters to be measured at the patient’s home, promote the diversity of the study population and allow the evaluation of therapeutic efficacy in the real world and thus to record completely new and patient-centred endpoints in areas of need not yet satisfied.
Already in June 2017, the CTTI (Clinical Trial Transformation Initiative), an organization that includes representatives of the FDA, pharmaceutical and biotech companies, CRO, ethics committees, academic institutions and patient groups, published a document entitled “Developing novel endpoints generated by mobile technology for use in clinical trials”, which contains recommendations for conducting studies focused on the patient through the use of mobile digital technologies, also providing concrete suggestions on how to organize this type of studies in certain diseases.
Genius Rosa, the telemedicine solution from Exom Group
Exom Group offers a sophisticated telemedicine platform, called Genius ROSA, configured for use in clinical trials. Genius Rosa is a multichannel, private, encrypted application, specific for clinical trials, for direct communication between doctor and patient and for remote monitoring of the patient’s clinical condition. Both the investigator and the patient use their own device (BYOD), a PC or a smartphone through an app, and the system operates through standard and familiar digital communication solutions, such as audio-video calls, chats, and text messages.
The system can send reminders (e.g. text messages, e-mails) to the patient or use automatic alerts when a specific study activity is to be performed (e.g. when a dose of medication is to be taken, or a remote visit is planned or measurements and exercises are to be performed). The patient can respond to electronic questionnaires (ePRO) from home and the data are automatically saved in the study database. Obviously, both the automatic alerts and the content of the information to be shared with the patient can be defined and adapted according to the characteristics of the study and the required language.
Genius ROSA can collect measured data from different devices at the patient’s home and send them directly to the study database through a secure and encrypted transmission. So far, more than 50 different devices are integrated into the Genius ROSA, from glucometers to spirometers, and many more.
The integration of Genius ROSA with the study’s eCRF and Genius ENGAGE application, for electronic informed consent, avoids the risk of collecting patient data both at the center and remotely, before the patient has signed the consent for participation in the study.
In conclusion, Genius ROSA is the ideal solution both to facilitate the enrolment of patients while respecting the ethnic-biological diversity of the population and to put the patient himself at the center of the clinical study. Its use is therefore very much indicated in rare diseases, oncology, pediatrics, chronic diseases, and elderly patients.
Ultimately, Genius ROSA reduces the overall costs of the study as well as the discomfort of the patient for repeated visits to the study center and ensures evaluation of the effectiveness of the treatment in the real-life conditions of the patient.