Although industry 4.0 has so far been the most advanced of all industrial revolutions, it is in no way the last frontier. Industry 5.0 is already on the horizon. Below you will see how it will impact clinical research.

The risk of infection and the difficulties in transport have led many patients not to go to hospitals for follow-up visits under study protocols. In addition, even the CRO monitors who should verify the regular conduct of the studies can no longer carry out their work at the clinical sites.

Recent estimates indicate that several thousand ongoing clinical trials worldwide have been discontinued, and those planned to start have been suspended. This situation involves thousands of hospitals, and hundreds of thousands of patients, with a substantial negative impact on the development of medical knowledge and, thus, on patients’ health. Besides, we should consider the economic damage due to the loss of billions of dollars invested in clinical trials that will, most likely, either not be regularly concluded or will end with a serious impairment of data completeness and quality and, therefore, be scientifically invalidated.

Apart from the possible measures that have been designed and implemented to minimize the devastating impact of the pandemic, what is happening today forces all decision-makers in the medical-pharmaceutical sector to seriously rethink the management of both health care and clinical research. The path of digitization is no longer an option. Still, a fundamental condition not only to ensure operational continuity in any trial but also to improve the efficiency of processes and reduce overhead costs.

Paradoxically, the pandemic has objectively and universally demonstrated that thanks to the widespread use of already existing digital technologies, communications, information and goods transactions, medical assistance, and many work activities have been maintained, even in the almost complete paralysis of all physical human mobility. We have all understood that it is possible to interact and exchange data, documents, information without necessarily moving people with a related waste of time, and increased costs.

Even clinical studies must inevitably become digital in all their processes, from the initial feasibility to the final report and analysis.

  • Why must patients go to the hospital or clinic to check or collect clinical information that can be simply and conveniently obtained through a telemedicine application?
  • Why limit the physician-patient interaction only during hospital visits at rigid and predefined time intervals, with a gap in communication and information between one visit and the next?
  • Why conduct expensive on-site monitoring visits to check data, documents, and experimental drug accountability that can otherwise be verified remotely with the same accuracy?
  • Why delay the verification and reconciliation of source data already available for days or weeks, to combine the availability of the investigator with that of the study monitor? Which will also delay the activity of data cleaning and database closing at the end of the study.

The answer to all these questions is always and only one: there are no valid and justified reasons to continue conducting clinical trials as in the past. It is also interesting to note that the regulatory authorities have also aligned themselves with this new vision.

Which technologies are more functional for remote and virtual clinical trials?

The essential components of any clinical trial are patient participation and the control that the procedures described in the study protocol and the regulations in place are fulfilled correctly and that the data entered in the study database are accurate and consistent with the original hospital records.

The use of telemedicine and virtualization of study visits (Genius Rosa), is a technological solution that facilitates patient participation and retention in the study as it reduces the burden of travel to reach the clinical site for follow-up visits repeatedly.

 

Genius ROSA
Remote Omnichannel Study Assistant

Dual ways (Doctor-Patient) private, study specific, encrypted

multichannel application

for remote patient visit & monitoring

This patient-centered approach is also an effective way to make the work of the study team faster and more flexible.

The use of electronic informed consent obtained remotely (Genius Engage) in appropriate clinical situations also contributes to patient recruitment, which is known to be one of the main reasons for the extension of deadlines in more than 80% of ongoing clinical trials.

The typical activities carried out by the monitor during the on-site monitoring visit (i.e., source data verification, control of the study file, and study drug accountability) can be safely and efficiently performed remotely (Virtual Site Monitoring). This goal can be achieved through validated solutions that comply with regulatory (GCPs) and privacy (GDPR) requirements, such as remote SDV (Genius rSDV), eTMF (Genius eTMF/eISF), and drug supply management (Genius eDSM).

In no case and for no reason whatsoever, any technological solution implemented in a clinical trial may not respect GCPs and, in particular, those essential principles concerning the protection of patient safety and data quality.

Finally, one should not forget that through Advanced Analytics that integrate and analyze data from different databases used in the clinical trial, one can gain information unimaginable with a traditional approach. They not only allow the real-time visualization of the metrics and study data for a Data-Driven Study Management.  With the Machine Learning capability, adequately trained, they can identify trends, outliers, deviations, changes of any parameter within the study, and over time, possible risks even if not known and defined a priori. As a result, this means that we can move from a risk-based to a risk-detection approach.

However, when considering and evaluating the hundreds of digital solutions currently offered on the market, it’s essential to verify the companies proposing them.

One should check if those solutions have been just recently developed during the pandemic, or if the companies have a proven track record of the digital innovation in clinical research, with the solutions having already been successfully used in previous studies.

Exom Group is a human digital CRO, founded in 2014, has the mission to combine the human expertise with the efficiency of digital technologies and advanced analytics to provide our customers with value-added services and exceptional study experience.

Exom Group for years has acquired a documented and successful experience in implementing a comprehensive, integrated platform purpose-built (Genius SUITE) to support the management, workflows, and processes of virtual trials.

The figure shows the various digital applications of Exom Group for a Clinical Trial 5.0 experience or also called Virtual Trial.

Conclusion

In conclusion, after the negative experience of the COVID-19 pandemic, we are confident that all stakeholders are fully aware that the digital transformation of clinical research is no longer postponable. All future studies should consider this new organizational approach for the benefit of patients, researchers, and also promoters.

Exom Group, the unique and first European full-service Digital CRO, is happy to discuss each new clinical study plan and to evaluate the most appropriate and efficient digital organizational solution for free.

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