U.S. patients with lower education and annual household income are less interested in and familiar with participation in clinical trials, according to a new study that recommends examining such socioeconomic factors when planning trials.
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The FDA has expanded the scope of its guidance on conducting clinical trials during the COVID-19 pandemic to apply to public health emergencies (PHE) and other disasters, issuing a rare direct-to-final guidance for immediate implementation.
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The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance with considerations for deciding whether a single trial plus confirmatory evidence will suffice for a development program.
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This week’s Pipeline features approval of an IDE for a study of an atrioventricular interval modulation therapy, two cancer drug approvals from the European Commission and initiation of a phase 1 trial for an HIV vaccine.
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