Clinical Trial Publication Policy

Summary of BD's Policy on Clinical Trial Registration, Results Disclosure and Publication

BD follows local regulatory requirements relating to clinical trial registration and disclosure of results. In the United States, BD complies with requirements of the FDA Amendments Act of 2007 (FDAAA) to both register and to post results of our applicable clinical trials (as defined in FDAAA), on www.clinicaltrials.gov.

BD commits to seek publication of results of its completed applicable clinical trials on any marketed product in the peer-reviewed scientific literature, regardless of trial outcome. BD supports recognized standards concerning authorship and publication, including those of the ICMJE (International Committee of Medical Journal Editors) and CONSORT (Consolidated Standards of Reporting Trials).

BD will provide final statistical reports of protocol-derived outcomes to external authors. BD reserves the right to review and comment on draft abstracts, manuscripts, presentations and other communications by external investigators regarding BD-sponsored trials, prior to submission or public disclosure, in order to protect intellectual property and confidential information. As study sponsor, BD does not approve or veto such publications.