• 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 ...

The US Food and Drug Administration (FDA) this week issued new draft guidance on study design and analysis for non-interventional studies being included as part of a regulatory submission.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

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 ...

Medical research is essential for advancing the understanding of health, diseases, and treatments. There are many types of studies that serve different purposes. Medical research, or health research, ...

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 ...

RCTs are considered the best way to determine whether a treatment is effective, and the reason is simple: researchers can hold all other variables constant across groups and study what happens when ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. A test-negative observational study design may be best ...

Clinical research is changing, although perhaps not fast enough to meet the challenges and seize the opportunities presented. The constantly increasing diversity and sophistication of health care ...