Decentralized clinical trials open drug development pipeline


There is no doubt that the Covid-19 pandemic has had a major impact on the life sciences. Not only has this pushed the boundaries of modern medicine, it has also created a significant backlog for clinical trials. More than 1,000 clinical trials have been suspended since the start of the pandemic, with almost all clinical research sites in the United States reporting one or more clinical trial delays.

The main reason for the backlog is the possibility of the virus spreading among clinical trial participants, nearby patients and healthcare workers. Staff shortages, supply chain issues and other restrictions only added to that. In response, clinical research organizations (CROs), life science companies, and technology providers have teamed up to develop remote processes for conducting clinical trials. The result being a major move towards decentralized clinical trials.

“The pandemic has created more urgency around the digital transformation of life science organizations,” said Anupam Nandwana, CEO of P360. “This has resulted in greater adoption of innovative new technologies and created a boom for tools that enable things like remote collaboration, remote monitoring, automated data collection and analysis, and more. These systems in turn transform the traditional approach to clinical trials.

Decentralized clinical trials gain momentum
With the emergence of these new technologies, CROs and life science organizations are able to more easily perform decentralized virtual clinical trials. And industry leaders are on a mission to make the practice of decentralized clinical trial administration the norm. The Decentralized trials and research alliance (DTRA) strives to unite industry stakeholders with a unique mission to make clinical trial participation widely accessible by advancing research policies, practices and new technologies in decentralized clinical research. With over 50 organizations engaged in this effort, it’s safe to assume that decentralized clinical trials are more than just a fad.

In addition to platforms like IQVIA Virtual Trials, smart devices are also helping researchers and pharmaceutical organizations get clinical trials back on track. Some healthcare professionals also believe that devices like Swittons can revolutionize the entire clinical trial process.

According to Dr. Kenyatta Cosby, “IoT-powered smart devices are great for clinical trials because they enable multi-point and omnichannel workflows. This new approach provides a consistent and reliable flow of data from patient to researcher. Given the current business environment for COVID-19, such an innovation has improved communication with patients within clinical trials. “

Technology puts the patient first
Patient centric is a priority for research organizations, clinics and hospitals, and more and more patients expect researchers to conduct clinical trials in a virtual environment. That’s why CROs and pharmaceutical organizations are taking steps to make their operations sustainable by meeting the needs of a diverse and tech-savvy clinical trial participant. Technologies such as the Internet of Things (IoT) hold promise for the future of clinical trials and meet the needs of patients.

With the proper implementation of remote patient-oriented technologies, virtual trials will bring improved treatments to patients in less time, at lower cost. They will also offer much needed help in the effort to retain participants, better monitor them and move the process forward. One of the things that gets in the way of many clinical trials, especially during a pandemic, is the recruitment of participants. It often has to do with location.

The location of the clinical trial may make it difficult for volunteer and qualified patients to participate. The location of the clinical trial also presents serious challenges in terms of the diversity of trial participants. For this reason, the FDA now requires organizations to make participation in trials less heavy, and recommends the implementation of advanced mobile tools instead of a site visit. Smart devices are responding to this call by enabling remote push-button participation of key populations wherever they are.

Technology is needed to get the most out of research data When the drug Gleevac was first approved by the Food and Drug Administration (FDA) in the early 2000s, some felt that a new era of precision medicine was born. With this, the life science industry has seen a significant increase in the amount of research data needed for clinical trials.

“The volume of data required for regulatory submissions from genomics-based studies has facilitated a new way of managing data acquisition, analysis and sharing,” added Dr. Kenyatta Cosby. “For this reason, an even greater amount of data is required today for the drug approval process. The good news, however, is that new clinical trial technologies are alleviating the problem of data overload. “

With smart devices and other related technologies now part of the virtual clinical research mix, researchers have the power to collect data like never before. A clinical study is nothing without data. However, in the past, it took a lot of work to find the value of this data. With today’s virtual testing technologies, research data can be collected and sent for analysis much more easily.

Beyond clinical trials
The systems that enable decentralized clinical trials are still evolving and will one day provide benefits far beyond clinical research.

“Smart devices will one day be able to automatically monitor patients while instantly transmitting results to researchers, without the patient having to do anything,” said futurist Brian FitzGerald. “Critical data will flow from patient to researcher in a simple and streamlined way. This will create significant efficiency gains and improve the development of advanced therapies. “

Technology is creating a new world for clinical research. Systems that enable decentralized testing are working to free the development pipeline from the backlog created by the Covid-19 pandemic, and future technologies will build on this to do even more. As technology companies, researchers, scientists, and government work together to further refine and improve the clinical trial process, the possibilities for improving patient outcomes become more exciting.

Photo: Warchi, Getty Images

Source link

Leave A Reply

Your email address will not be published.