Education, Income Level Influence Trial Perceptions, Study Says

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. Read More

FDA Broadens Pandemic-Era Guidance to Cover Trials During PHEs, Disasters

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. Read More

FDA Expands on Showing Effectiveness in a Single Trial with Confirmatory Data

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offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance with considerations for deciding whether a single trial plus confirmatory evidence will suffice for a development program. Read More

Drug & Device Pipeline News

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. Read More