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Ancillary studies in clinical trials
Jacqueline Dunbar-Jacob1, Eleanor Schron
1University of Pittsburgh, School of Nursing, PA 15261-0001, USA. dunbar@pitt.edu
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.