Observational studies are critical in evaluating the long-term safety and effectiveness of new therapies on patients’ lives. However, two major shifts are significantly changing the research ...

• Observational studies can be powerful tools for generalizing the results of randomized controlled trials (RCTs), but only if they are well designed to answer specific clinical questions. • To ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. A test-negative observational study design may be best ...

Observational studies are emerging as fundamental sources of information about vaccine effectiveness outside the controlled environment of randomized trials, and they are being used to generate ...

A new study published in Therapeutic Innovation & Regulatory Science provides crucial insights into the design and implementation of multi-national observational studies for post-marketing drug safety ...

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission. The draft ...