randomized controlled trials Archives - Medical Design Sourcing

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A method for comparing multiple therapies within a single analysis, a Network Meta-Analysis (NMA), makes use of direct and indirect evidence within a network of randomized controlled studies.

While randomized controlled trials (RCTs) generally provide higher-quality evidence than NMAs, head-to-head RCTs are often slow and expensive.

Payers worldwide have turned to NMAs in recent years to assess the value of various treatment options, according to Dr. Philip J. Mease, a rheumatologist affiliated with the Swedish Medical Center/Providence St. Joseph Health and the University of Washington in Seattle.

In the United States, insurance companies wanting to ascertain the value of various medications for a single indication have turned to NMAs.

“In the absence of head-to-head trials, NMAs are needed for insurers and payers to figure out a drug’s value proposition,” Mease…

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Few of the COVID-19 therapies in use in the U.S. have won full FDA approval. The widespread use of emergency use authorization may accelerate the distribution of disease-modifying agents and vaccines to patients, but it also could cause regulatory complications.

“I’m nervous about the prospect of there never being a COVID vaccine that meets the FDA’s approval standard,” said Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland.

The FDA’s decision to grant emergency use authorization to investigational vaccines could lead to the development of a “marketplace” where vaccines are deemed “good enough to be authorized, but never approved,” Doshi opined in the public comment period of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Johnson & Johnson’s vaccine.

Further compl…