Creation and implementation of a historical controls database from randomized clinical trials.
Ethical concerns about randomly assigning patients to suboptimal or placebo arms and the paucity of willing participants for randomization into control and experimental groups have renewed focus on the use of historical controls in clinical trials. Although databases of historical controls have been advocated, no published reports have described the technical and informatics issues involved in their creation.
Author(s): Desai, Jigar R, Bowen, Edward A, Danielson, Mark M, Allam, Rajasekhar R, Cantor, Michael N
DOI: 10.1136/amiajnl-2012-001257