The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an ...
The European Medicines Agency (EMA) is proposing a new guideline on sponsors’ use of non-inferiority designs to assess the safety and effectiveness of new drugs in clinical trials. The proposal aims ...
Non-inferiority trials have become an essential instrument in clinical research, particularly when the goal is to demonstrate that an experimental treatment is not unacceptably worse than an ...
Protocol fidelity and transparency about changes are essential to the credibility of randomised controlled trials In recent ...
ONS-5010 shows non-inferiority to Lucentis at 12 weeks; BLA resubmission planned for Q1 2025, with $20.4M in proceeds expected. ONS-5010 demonstrated non-inferiority to ranibizumab at week 12, ...
Ultrahypofractionated radiotherapy demonstrated non-inferiority to conventional fractionation with higher 10-year failure-free survival with similar toxicity profiles in patients with intermediate- or ...
SAN ANTONIO -- Starches may be safe after all for fluid resuscitation in perioperative medicine, based on the PHOENICS non-inferiority trial addressing longstanding concerns from regulators and the ...
The NRG Oncology NRG-HN005 phase II/III clinical trial did not meet the non-inferiority criteria to proceed to the phase III portion of the study. The phase II portion of the NRG-HN005 evaluated two ...
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