The Decentralized Trials and Research Alliance (DTRA) recently launched to accelerate the broad adoption of patient-focused decentralized clinical trials and research.
It plans to unite stakeholders across the health spectrum to further policies, research practices and technology innovation for decentralized clinical trials.
The alliance is currently made up of more than 50 life sciences and healthcare organizations, including AstraZeneca, the U.S. Food and Drug Administration, Pfizer and others.
DTRA member organizations will help identify gaps in the space and provide expertise to advance best practices through education and communication. The alliance is currently accepting organizations on its website.
WHY THIS MATTERS
As a result of the travel restrictions and social distancing recommendations of the COVID-19 pandemic, clinical trials across the world were forced to suspend operations. In fact, as many as 905 trials in the U.S. were postponed as a direct result of the pandemic, according to a paper from the Wolters Kluwer Public Health Emergency Collection.
Decentralized clinical trials have emerged as an answer to that problem.
“The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate,” said Amir Kalali, M.D., a co-convenor of DTRA, in a statement. “The COVID-19 pandemic has forced organizations to adopt decentralized methodologies, which have the potential to broadly accelerate drug development.”
This form of research offers opportunities for remote data collection using wearables and broader participant recruitment, according to a paper published in Nature. However, the paper also noted that much of the data used in digital clinical trials are collected using consumer-grade products, which would need to be upgraded to medical-grade to be useful in a clinical trial.
THE LARGER TREND
Digital clinical trials have already established a foothold in the space, as about 76% of respondents from a Pharma Intelligence survey said the pandemic increased the use of remote trials. Additionally, more than 90% said they expect these increases to be maintained in the long term.
Labcorp recently upgraded its clinical trial processes with a new technology platform. It seeks to more easily connect patients to trials, decrease administrative tasks, improve trial resiliency and enhance studies through the use of data and technology.
The cloud-based clinical trial platform Castor raised $12 million in a Series A funding round earlier this year to help facilitate COVID-19 research.
Other innovators in the clinical trial space include Unlearn, a startup creating digital twins used in the control arm of research. A digital twin is a virtual replica of a person that can, in the case of Unlearn, be used to describe what would happen if the participant had been given the placebo in the trial. The company raised $15 million in its recent Series A funding round.
ON THE RECORD
“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives,” said Craig Lipset, a DTRA co-convener, in a statement. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders we can remove remaining barriers to adopting new policies and practices that can impact patients today.”