By Robert E. Winkler MD – COVID-19 vaccines were developed extremely fast, approximately nine months from pandemic emergence to FDA approval in the U.S. This is, by a landslide, a record for one of the fastest development (and approval) of a vaccine, and significantly faster than traditional R&D timelines.
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By Adam Samson – In order to understand the nuances of virtual (i.e. remote-based) and traditional (i.e. brick-and-mortar) trial sites, we need to first understand decentralized clinical trials (DCTs). The exact definition of decentralized clinical trials varies, but essentially boils down to this…
By Marie E. Lamont – Hospitals are still overwhelmed with COVID-19 cases. Patients have postponed diagnostic tests and screenings. Researchers are still focusing their attention on combatting the virus. It’s no surprise that clinical trials have plunged.
By Dr. Tandy Tipps – Patients and doctors missed or cancelled an estimated 22 million cancer screenings in the first four months of the coronavirus pandemic, resulting in an estimated 80,000 missed diagnoses, according to research published last year. Another study found that diagnoses for six major cancer types dropped by almost half.
By Daniel Cidon – Our public health crisis is a sobering example of just how desperately seamless information sharing capabilities are needed. While EHRs have become commonplace, the disjointed, competitive nature of IT systems contributes to a proliferation of duplicate and incomplete patient records.
The National Institute of Allergy and Infectious Diseases established new clinical trials network aiming to enroll thousands of volunteers in large-scale clinical trials testing vaccines and monoclonal antibodies intended to protect people from COVID-19.
By Owen Faris & Jeffrey Shuren – At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.