The Society for Clinical Trials supports United States legislation mandating trials registration. Position paper.
The official position of the Society for Clinical Trials is to support legislation in the United States and internationally that mandates registration of all controlled clinicals trials at or before enrollment of the first participant. The major trial sponsor would be responsible for ensuring contribution of trial information. The mechanism for registering trials would be through research ethics review boards, and registration would be required for ethics approval and before trial initiation. Standardized data and a unique identification number would be available for each registered trial.
Dickersin
Kay
K
Department of Community Health, Brown University, Providence, RI 02912, USA. kay_dickersin@brown.edu
Davis
Barry R
BR
Dixon
Dennis O
DO
George
Stephen L
SL
Hawkinse
Barbara S
BS
Lachin
John
J
Peduzzi
Peter
P
Pocock
Stuart
S
D018849:Controlled Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000379:methods; D028744:Ethics Committees, Research; D033161:Government Regulation; D006801:Humans; D012042:Registries; D012955:Societies, Medical; D014481:United States