Universities call out NIH for classifying basic research as clinical trials

Four leading US university associations have written to the National Institutes of Health expressing concern over the agency’s apparent change in the definition of clinical trial.

In a letter addressed to Michael Lauer, NIH deputy director for extramural relations, the associations query why the agency has chosen to expand its definition of clinical trials to include basic research.

According to an updated definition, several examples of fundamental health-related research studies seem to fall in the category of clinical trial, the associations said. Clinical trials must comply with stricter regulations than other types of research.