Glossary

Medical Subject Headings (MeSH)

The MeSH thesaurus is a comprehensive, controlled and hierarchically-organized vocabulary produced by the National Library of Medicine. It is used for indexing, cataloging, and searching of biomedical and health-related information.

Open Payments Data

Database containing records of payments made by drug and medical device companies to physicians and teaching hospitals in the US.

Physician Payments Sunshine Act

US healthcare law that requires manufacturers of drugs, devices, biologicals, or medical supplies to report certain payments or other transfers of value to physicians and teaching hospitals annually.

Precision Medicine

An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person

Principal Investigator

Principal investigator (PI) is the researcher responsible for the management, conduct, and reporting of a research project. This includes responsibility for all aspects of the project, e.g. financial, compliance, personnel matters as well as coordination with internal stakeholders and external partners and collaborators.

Real-world data/Real-world evidence

The FDA defines real-world data (RWD) as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources”. Real-world evidence (RWE) is defined as “clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. ”

Surrogate Endpoint

A surrogate endpoint is a biomarker intended to substitute for a clinical endpoint.