TY - JOUR AU - Zou, Constance X. AU - Becker, Jessica E. AU - Phillips, Adam T. AU - Garritano, James M. AU - Krumholz, Harlan M. AU - Miller, Jennifer E. AU - Ross, Joseph S. PY - 2018 DA - 2018/10/23 TI - Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study JO - Trials SP - 581 VL - 19 IS - 1 AB - Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA-regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied. SN - 1745-6215 UR - https://doi.org/10.1186/s13063-018-2957-0 DO - 10.1186/s13063-018-2957-0 ID - Zou2018 ER -