Good experiments start with good planning. The analysis of genetic and molecular information involves increasingly sophisticated tools and methodologies, many of which are advancing at a fast pace.

The US Food and Drug Administration (FDA) recently highlighted three case studies showing how sponsors can incorporate innovative study designs in their clinical trials using the agency’s Complex ...

Observational study designs like cohort, case-control, and cross-sectional are the backbone of epidemiology, but each comes with unique strengths, limitations, and bias risks. Understanding these ...

Clinical trials are well-controlled and designed experiments that aim to prove that an Investigational Medicinal Product (IMP) is effective. Clinical trial data is submitted to the national health ...

Noninferiority clinical trials have become a major tool for the evaluation of drugs, devices, biologics, and other medical treatments. Treatment with placebo or with a no-treatment control in a study ...

As biomarker studies employ increasingly complex and expensive genomics and other correlative methods, it is increasingly important to rigorously design these studies and analyze the downstream ...

Once you have determined your research question, the next step is to decide on a research design. As random assignment tends to be challenging in SoTL, most projects tend to fall into the ...

Cohort studies are a type of research design. They are also called longitudinal studies because they follow groups of people over time. Results from cohort studies can help people understand human ...

FDA considered the planned HER-096 Phase 2a study design appropriateStudy design finalized; approximately 100 patients to be enrolledMore than 50% of Phase 2 funding secured or identifiedEspoo, ...

We study design in all its manifestations, with a focus on its implications. Do you care about design and its impact on the individual, society, and the environment? Are you interested in honing your ...