May 2006

Caution Regarding the Use of Pilot Studies to Guide Power Calculations for Study Proposals

Author Affiliations

Author Affiliations: Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford (Drs Kraemer, Tinklenberg, and Yesavage and Mr Noda), Department of Psychiatry, University of California, Los Angeles (Dr Mintz), and Veterans Affairs Palo Alto Health Care System, Palo Alto (Drs Tinklenberg and Yesavage), Calif.


Copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2006

Arch Gen Psychiatry. 2006;63(5):484-489. doi:10.1001/archpsyc.63.5.484

Clinical researchers often propose (or review committees demand) pilot studies to determine whether a study is worth performing and to guide power calculations. The most likely outcomes are that (1) studies worth performing are aborted and (2) studies that are not aborted are underpowered. There are many excellent reasons for performing pilot studies. The argument herein is not meant to discourage clinical researchers from performing pilot studies (or review committees from requiring them) but simply to caution against their use for the objective of guiding power calculations.