KIELTYKA GLADKOWSKI KG LEGAL is heavily involved in complex assistance to clients operating in clinical trials sector and it diligently observes the market in this respect within new technologies used in clinical trials. In 2020 there have been noted considerable challenges for the science and technology, including technologies in clinical trials. The pressure that has been placed on the healthcare systems turned out to be unprecedented. The rapid spread of coronavirus has lead to the global debate on the reassessment of the approach to clinical trial conduct. Previously, it was believed that the driving force of medicine development is technology.
In March 2020 biopharmaceutical companies managed to conduct more than 9,000 clinical trials in the U.S. However, the pandemic outburst has brought the future biopharma development into a question. Nevertheless, some researchers decided to take the advantage of the wide range of available information and communication technology devices. Combining novel tactics like mailing medications and relying on digital technologies such as transmitting photos of home-based blood pressure readings via text message has resulted in remote clinical trials. At this point, it is fundamental to stress the surprising advantages of clinical trials conducted remotely, which are:
In the era of new technologies each year more and more clinical trials are incorporating digital tools to monitor patients remotely. Particularly noteworthy are so-called wearable technologies which are electronic devices aimed to “be worn as accessories, embedded in clothing, implanted in the user’s body, or even tattooed on the skin”. Although the pace of innovation in wearable technology has never been faster, the concept itself is nothing new, like glucose monitors for diabetics, artificial cardiac pacemakers, wearable blood pressure monitors.
In recent years, the use of advanced analytical technologies, such as artificial intelligence (AI) has exploded. Taking the pandemic into consideration, we can say, with a high degree of probability, that if it was not for the Covid-19, the AI development in clinical research would not be at the same level. The rapid spread of the disease forced scientists to adjust AI to the new challenges, so it could analyse health data as quickly as possible.
Starting from the beginning, using AI in the healthcare sector has helped to reveal SARS-CoV-2 virus and analyse its genetic information. Moreover, AI was a tool used to predict early Covid-19 symptoms and as a consequence control the spread of infection. Finally, as it is anticipated by the scientists, AI may also predict the next pandemic.
Nevertheless, AI in recent years is not only about the Covid-19. For example, for pharma industry, AI is becoming a significant tool which can be used in all stages of drug development, such as dentification and validation of drug targets, designing new molecules, repurposing of old drugs, improving efficiency of clinical trial conduct, and pharmacovigilance. This seems to be even more important, taking into account the fact that clinical drug development is the field plagued by high costs and high failure rates.
With the need of conducting clinical trial activities remotely, the Covid-19 pandemic has accelerated the adoption of decentralized clinical trials (DCTs), which immediately have become a new priority for pharmaceutical industry. The term decentralized trial may bring to mind that the entire process of clinical trial will be performed remotely. This might be true, yet only partly. The concept of decentralized clinical trial combines a wide range of solutions that include digital tools for collecting consent data, the use of home health providers, direct-to-patient drug distribution, remote monitoring and diagnostics, and the use of local labs and imaging centers.
To spread the idea of DCTs even more effectively, in December 2020 over 50 biopharmaceutical organizations leaders decided to establish the Decentralized Trials and Research Alliance (DTRA). This global cross-industry coalition aims to make the participation in clinical trials more accessible, while spreading the adoption of decentralized clinical trial methods through education and research.
Dealing with the big amount of data in healthcare field requires adjusted solutions and infrastructure, especially when it comes to pooling data across studies, sponsors, and countries. There is one potential solution coming from coordinated efforts of pharmaceutical, academia and government agencies working as partners. Considering the ongoing epidemiological situation, creating a global clinical network adopted by all stakeholders with access to real-time epidemiological data employing predictive analytics and models would enable coordinated and agile execution so the trials can register patients quickly and safely despite fluctuations in infection rates. In response to dynamically changing pandemic waves, such a tool would also foster flexibility in recruitment strategy and would make site identification, initiation, and monitoring more efficient.
STAT E-Book. Oct 2021. How advances in technology are transforming clinical trials