Even before the crisis hit, there had been a push towards the digitization of clinical research, but this epidemic brings with it a greater urgency. The implementation of digital technologies such as remote monitoring of patients and eSource for collecting and verifying data from hospital records could be crucial, not only to overcome the current crisis but above all to avoid similar problems in the future and contribute to respect for the environment.

The coronavirus epidemic has triggered a strong call for action across the international biopharmaceutical community to treat, diagnose and prevent the spread of the virus, but it has also revealed some infrastructure weaknesses that have disrupted traditional clinical trial processes with hitherto unpredictable consequences.

For pharmaceutical companies, one of the most significant operational impacts of the virus spread will be on clinical trials. Healthcare resources are being diverted to deal with the epidemic, and patient visits to hospitals are limited to prevent the spread of the disease.

In the areas most affected by the epidemic, CROs are reporting interruptions of normal clinical trials, difficulties with starting new projects, and the recruitment of new patients into ongoing trials. In some cases, enlisted patients are facing problems in carrying out the study visits and, therefore, also in the continuation of their treatment.

For reasons of health precaution, monitoring visits to the clinical center are regularly canceled and postponed until a date to be set, thus increasing the risk of losing control over the management of the study and especially over the quality and accuracy of the data.

Full digitization in Clinical Trials is no longer deferrable

Thanks to a connected digital economy – and the many actors that enable business within and through the ecosystems that support it – businesses, workers, and consumers can continue to interact and do business, even if the virus continues to spread.

Everywhere – not just in the areas most affected by the virus – social networks allow people to stay in touch with their loved ones. With smartphones, people can talk and see each other without having to meet physically.

Elderly people, for whom the virus can be more debilitating, do not have to leave their homes to get food or medicine thanks to e-commerce. Through telemedicine applications, they can stay in constant contact with their doctor without having to make inconvenient and unnecessary trips to hospitals or doctor’s surgeries.

Of course, digitization is not the perfect solution, but in the absence of the digital economy, things could be much worse.

Unfortunately, in clinical research, digital solutions are not very widespread, and those used are sometimes fragmentary and partial.

People continue to prefer to move to verify data and collect documents rather than using more modern, efficient, cheap, and secure means of transfer. It is preferable to ask patients and their families to take the discomfort of a trip, sometimes even a long one, to go regularly to the clinical center to check clinical parameters that could be easily measured at home with appropriate devices and whose values are transmitted in real-time to the doctor and then collected in the database of the study.

The causes of this phenomenon are not the lack of adequate technological solutions or their noncompetitive cost, but rather a certain mindset that resists to changes and the erroneous belief that the digital management of a clinical trial poses problems from a regulatory point of view.

Exom Group’s digital solutions

Since its establishment Exom Group has put the digitization of clinical trial processes at the heart of its mission, becoming the first true “Full-service Digital CRO” in Europe.

Among the various modules of our Genius SUITE Digital Ecosystem, we would like to focus on the application for the direct collection or remote verification of source data  (Genius eSource) and the platform for remote monitoring and tele-visit of the patient (Genius Rosa), which significantly reduce the need to move both study staff and patients.

Genius eSource in the FIRE version (Fast Interoperability for Research Efficiency) eliminates the need for verification of source data because, directly from the electronic hospital record (HER), a copy is created and automatically uploaded into the database (eCRF) of the clinical trial.

If a direct connection between the EHR and the eCRF is not feasible, the alternative is to use  Genius eSource in the eCRF version, in which the investigator uploads a “certified electronic copy” of the original source data and the site monitor remotely verifies this data (SDV) against those of the eCRF.

Genius ROSA, is a multichannel communication platform between doctor and patient integrated with over 50 medical devices that:

  • ensures regular patient monitoring at home
  • measures patient-centric clinical outcomes through home devices
  • breaks down geographical barriers
  • increases compliance and patient retention in the study
  • uses existing and common digital communication solutions
  • reduces overall study costs and patient discomfort for repeated visits to the clinical center

Conclusion

The crisis we are experiencing should ultimately push pharmaceutical and biotech companies, stakeholders and regulators to accelerate the adoption of digital solutions for the conduct and monitoring of clinical trials, not only to make processes more efficient and improve data quality but also to prevent that similar epidemics in the future could seriously disrupt the execution of clinical trials.

Such a scenario would mean not only the loss of substantial economic investments and also the futility of the contribution of patients who voluntarily decided to participate in a clinical trial in the interest of medical progress for the development of better treatments.

We are confident that the impacts of the “Covid-19 Black Swan” will be a stimulus to address and solve the problems of clinical research with a view to innovation, efficiency, transparency, and security.

Finally, we should not forget the positive contribution that the reduction of travel and relocation of people, replaced by digital contacts, has on the respect for the environment and therefore on the general health of the population, as well as on costs.

 

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