Digital clinical trials could lead to new, more effective therapies

As the world waits for the approval and release of a COVID-19 vaccine, many are learning about the historically lengthy and arduous procedures required to conduct clinical trials.

For decades, the clinical trial process has remained largely untouched by new digital technologies, limiting the researchers and patients who could participate and slowing the development of new and effective therapies. However, as the digital revolution touches nearly every aspect of society, leveraging technology for clinical trials offers the opportunity to change the way we approach the development of new vaccines and therapies.

In a world of social distancing and remote work, a new digital solution is seeking to revolutionize clinical trials as it continues to add researchers, providers and global pharmaceutical companies at an exponential rate. The Cognizant Shared Investigator Platform (SIP), launched in 2016 by the IT services giant together with the world’s largest pharmaceutical companies, offers a solution to the hurdles of legacy clinical trials at no cost to medical investigators.

Speed and efficiency

Using the latest digital technologies, automation and remote access services to connect investigators with clinical trial sponsors such as research universities and biopharmaceutical companies, this platform offers a new digital approach to improving the speed and efficiency of bringing new vaccines and therapies to the public.

Until the development of digital solutions like SIP, the clinical trial process, developed in the 1940s, had been an administrative burden that led to more than half of all clinical investigators never participating in more than one clinical trial. Investigators cite the time required to implement clinical trials as an overwhelming challenge, and few independent investigators from small medical practices would even attempt a clinical trial.

Today, much of that burden can be avoided through digital streamlining, eliminating redundant paperwork, reducing manual errors and expediting the rate at which clinical trials can get up and running on this SIP solution. In one example, a global biopharmaceutical company saw the time required for their regulatory submission process fall from 65 days to nine, allowing them to expedite their study by two months.

Diverse patient populations

As a result of digital clinical trial platforms like SIP, investigators are demonstrating a willingness to run multiple clinical trials, even outside of the United States — increasing the diversity of clinical trial participants. In fact, SIP has more than 110,000 users across 84 countries, of which thousands represent small clinical practices — an unprecedented number, and the number of users is doubling annually. It also allows investigators to adjust therapeutic protocols in real-time to reflect local conditions.

Srinivas Shankar, Cognizant’s Global Head of Life Sciences who is in charge of SIP, said, “Providing access to a greater range of clinical practices increases the opportunity for more diverse patient populations to participate in clinical trials. Such increased diversity helps ensure that those populations most likely to take a specific medication are appropriately represented in studies prior to the drug’s launch.”

Looking to the future and the need for speedy and safe therapies, sometimes in socially distant environments, “digital” appears to be the answer. In the case of the SIP solution, participating investigators found that their research was not disrupted by the pandemic — indeed, its use skyrocketed.

Since the platform is entirely digital, allowing for greater remote collaboration, between April and August 2020 the platform saw a doubling in the number of active studies to nearly 1,200, and a 30% increase in the number of users over the same period. That means that despite the global impact of the pandemic, research has continued into a range of diseases, including cancers and chronic conditions.

“The future may have uncertainty, but the opportunities provided to us through digital technology ensure our race toward cures will continue,” noted Shankar. “Our Shared Investigator Platform has an important role to play in the development of new vaccines and therapies. As we look to technology to both connect the world and improve the efficiency with which we work together, digital clinical trials open the door to global partnerships that could yield important developments in life sciences.”

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