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ancillary studies, controlled clinical trials



  1. Dunbar-Jacob, Jacqueline
  2. Schron, Eleanor


Background: Randomized clinical trials offer unique opportunities for testing questions of relevance to nursing through the mechanism of ancillary studies.


Approach: A review of the strategies to prepare and negotiate an ancillary study through a randomized clinical trial structure is offered.


Results: Several steps are required that are unique to the ancillary studies arena. These steps involve (a) accessing the main trial; (b) obtaining approval; (c) funding; and (d) publication. There are hurdles and strategies to address them.


Discussion: Collaboration and compromise are the keys to success in the conduct of an ancillary study of scientific merit. The cost-effectiveness, excellent collaboration, and the opportunity to further develop one's research skills and research program in a highly scientific interdisciplinary environment are well worth the effort.