Clinical trial registration and reporting: a survey of academic organizations in the United States.

ABSTRACT:

Background

Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations.

Methods

We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA.

SUBMITTER: Mayo-Wilson E 

PROVIDER: S-EPMC5930804 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature