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The Clinical Trials Industry’s Weekly News Update

Coalition calls for cancer trials to embrace digital tech

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Companies running cancer drug trials should embrace telemedicine, advanced diagnostics and remote monitoring according to a new group.

The Bloomberg New Economy International Coalition – whose members include experts from academia, industry and regulatory agencies – called for change in a paper in Nature Medicine, citing the pandemic as the catalyst.

“The COVID-19 pandemic upended the infrastructure and delivery of oncology clinical trials worldwide. In an effort to allow potentially lifesaving experimental therapies for patients to continue during the pandemic, government regulators, medical centres and clinical trial sponsors implemented unprecedented flexibilities in the conduct of clinical trials.”

These flexibilities included the use of remote monitoring which “illuminated how digital technology and collaboration may improve access, alleviate patient burden, and increase the diversity of participants [in trials],” according to the group.

Coalition member Richard Pazdur, director of the US FDA’s oncology centre, said, “With a coordinated, global multi-stakeholder effort, we absolutely can convert these improvements to a permanent paradigm change in cancer patient medicine post-pandemic.

“Achieving broader diversity across clinical trials is a key priority for the FDA and finding ways to lower barriers for patients to benefit from trials is necessary both here and abroad” he said.

The Coalition will explore ways to drive better access and international collaboration to clinical trials, and encourage regulatory harmonization that would accelerate the development of novel cancer treatments, screening, and prevention.

For example, in the U.S 74% of patients receive treatment in their communities. To take part in cancer studies, patients need to be referred by their local oncologist whose knowledge of ongoing trials may be limited. This is a particular problem, because most cancer trials only take place at academic medical centres.

To address this the Coalition argues that technology should be used to build an interactive international database in which patients with cancer may elect to enter at diagnosis and data may be added over time, including digital pathology and molecular profile.

“Once patients are matched to trials, enrollment could be managed by a hub-and-spoke network where academic or large community cancer centers serve as a hub for distributed clinical research sites in the wider community.”

Image: Stock Photo Secrets

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