The U.S. Food and Drug Administration (FDA) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, ...

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA ...

The International Council on Harmonisation (ICH) announced on Friday the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies ...

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, ...

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 ...

Objective The aims of this study, which uses a trial within a cohort design, were to determine the efficacy of a web-based intervention to increase moderate-to-vigorous intensity physical activity ...