240 17 JANUARY 2020 • VOL 367 ISSUE 6475 sciencemag.org SCIENCE

ILLUSTRATION: DAVIDE BONAZZI/SALZMAN ART

FEATURES

F

or 20 years, the U.S. government

has urged companies, universities,

and other institutions that conduct

clinical trials to record their results

in a federal database, so doctors

and patients can see whether new

treatments are safe and effective.

Few trial sponsors have consis-

tently done so, even after a 2007

law made posting mandatory for many tri-

als registered in the database. In 2017, the

National Institutes of Health (NIH) and

the Food and Drug Administration (FDA)

tried again, enacting a long-awaited “final

rule” to clarify the law’s expectations and

penalties for failing to disclose trial results.

The rule took full effect 2 years ago, on

18 January 2018, giving trial sponsors am-

ple time to comply. But a Science investi-

gation shows that many still ignore the

requirement, while federal officials do little

or nothing to enforce the law.

Science examined more than 4700 tri-

als whose results should have been posted

on the NIH website ClinicalTrials.gov

under the 2017 rule. Reporting rates by

most large pharmaceutical companies and

some universities have improved sharply,

but performance by many other trial

sponsors—including, ironically, NIH itself—

was lackluster. Those sponsors, typically

either the institution conducting a trial or

its funder, must deposit results and other

data within 1 year of completing a trial. But

of 184 sponsor organizations with at least

five trials due as of 25 September 2019,

30 companies, universities, or medical cen-

ters never met a single deadline (see https://

scim.ag/ctgov). As of that date, these habit-

ual violators had failed to report any results

for 67% of their trials and averaged 268 days

late for those and all trials that missed their

deadlines. They included such eminent

Many clinical trial results aren’t posted publicly, as U.S. law requires—

and a promised crackdown has fizzled

By Charles Piller

TRANSPARENCY ON TRIAL

Published by AAAS