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Decentralized Clinical Trials Are Opening the Development Pipeline

TAGS: Software
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With the emergence of new technologies during the COVID-19 era, decentralized, virtual clinical trials are gaining steam among life sciences organizations.

There is no doubt that the COVID-19 pandemic has had a major impact on life sciences. Not only has it pushed the limits of modern medicine, but it has also created a significant backlog for clinical trials as well. More than 1,000 clinical trials have been put on hold since the pandemic began, with nearly every clinical research site in the United States reporting one or more clinical trial delays.

The primary reason for this backlog is the possibility of virus spread among clinical trial participants, nearby patients and healthcare workers. Staffing shortages, supply chain issues and other restrictions have only added to this. In response, Clinical research organizations (CROs), life sciences companies, and technology providers have teamed up to develop remote processes for operating clinical trials. The result being, a major shift towards decentralized clinical trials.

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

Decentralized clinical trials are gaining steam

With the emergence of these new technologies, CROs and life sciences organizations are able to more easily perform decentralized, virtual clinical trials. And industry leaders are on a mission to make the practice of administering decentralized clinical trials the norm. The Decentralized Trials & Research Alliance (DTRA) is working to unite industry stakeholders with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research. With over 50 organizations committed to this effort, it is safe to assume that decentralized clinical trials are more than just a fad.

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

According to Kenyatta Cosby, MD, “IoT-powered smart devices are perfect for clinical trials in that they enable multi-point, omnichannel workflows. This new approach delivers a consistent, reliable data flow from the patient to the researcher. Given the current COVID-19 business environment, such innovation has improved patient communication within clinical trials.”

Technology puts the patient first

Patient-centricity 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 future-proof their operations by meeting the needs of a diverse, tech-savvy clinical trial participant. Technologies like the Internet of Things (IoT) hold promise for the future of clinical trials and meeting the needs of patients.

With the appropriate implementation of remote patient-facing technologies, virtual trials will bring improved treatments to patients in less time, at a 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 hinder many clinical trials, especially during a pandemic, is the recruitment of participants. This often has to do with location.

The clinical trial location can make it difficult for willing and qualified patients to participate. The location of the clinical trial also presents serious challenges when it comes to the diversity of trial participants. Because of this, FDA now requires organizations to make trial participation less burdensome, and recommends the implementation of advanced mobile tools in lieu of a site visit. Smart devices answer this call by enabling remote, push-button participation by key populations no matter where they might be.

Technology is needed to make the most out of research data

When FDA approved the drug Gleevac in the early 2000s, some felt a new era of precision medicine was born. With this, the life sciences industry experienced a major increase in the amount of research data needed for clinical trials.

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

With smart devices and other related technologies becoming part of the virtual clinical research mix, researchers have the ability to collect data like never before. A clinical study is nothing without data. However, in the past, a lot of heavy lifting was needed to find the value of that data. With today’s virtual trial technologies, research data can be collected and sent for analysis much more easily.

Beyond clinical trials

Systems that enable decentralized clinical trials are still evolving, and one day will offer benefits well beyond clinical research.

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

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

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