Technology, the key to generating clinical studies during COVID-19
by Ángel Barrera, September 2, 2020
As the COVID-19 pandemic spread around the world throughout 2020, the negative impact of the virus has become more obvious, even in the development of clinical studies of other diseases. With the travel restrictions imposed by governments and the fear of contracting the virus among both the patients participating in the studies as well as the monitors, people stopped coming to hospitals.
As a result, it has not been possible to carry out the supervision of clinical studies in hospitals or to deliver medications for research in the usual way; in addition, there has been a significant reduction of patient participation in those activities. For example, in an article on cancer network, it was shown that the recruitment of oncology patients between January and the end of May of this year was 41.8% lower than in the same period in 2019.
In consequence, and taking into account the fact that the development of clinical studies is of vital importance for the improvement of treatments and therapies for different diseases, the researchers and the companies in charge of those studies began to mobilize themselves to generate digital studies (in remote format), prioritizing the safety of the patients and the integrity of the studies.
Owing to the growth of telemedicine and other digital tools, in March of 2020 both the EMA and the FDA developed and published their guides to the correct development of clinical trials during the COVID-19 pandemic, “Guidance of the Management of Clinical Trials during the COVID-19 pandemic” and “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency”, respectively. These provide certain recommendations to ensure the safety of the participants and their data during any trials that might be underway at this time. They allow, and even recommend, the use of telemedicine, remote monitoring of patients, and other tools to encourage continuation of these trials, taking patient safety and data integrity as priorities.
With these guides, the regulatory entities have created a favorable environment for the increased use of digital tools in clinical studies, encouraging progress in studies that may have come to a standstill. At this time, these recommendations are only applicable during the pandemic, although it is hoped that this turning point will facilitate their implementation over the long term.
At Persei vivarium, we believe that digital tools will become the key to the improvement of the process and results of clinical studies, during the pandemic as well as in the future. We are already seeing how these tools are helping to accelerate their development, increasing the speed and reliability of the data collection, while respecting regulation and good practices. We are taking advantage of the situation that we are living through to make use of technology to continue improving research and the approach to diseases.