Margaret AWinkerMD, Deputy EditorIndividualAuthorPhil B.FontanarosaMD, Interim CoeditorIndividualAuthor
Copyright 1999 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.1999
To the Editor: The clinical trial by Rendell
et al1 designed to test whether sildenafil
is a safe and effective treatment for ED in men with diabetes used the following
inclusion, and by inference, exclusion criteria: "The patients also had to
be in a stable relationship with a female partner
for at least the previous 6 months [emphasis added]." The inclusion and exclusion
criteria of a clinical trial determine not only who has access to a clinical
trial, and therefore to a promising new therapy, but the generalizability
of the trial's results.2 Therefore, it is
essential to consider why the investigators required that the man's partner
be female, and not simply male or female.
Karlawish JHT, Casarett D. Sildenafil for Diabetic Men With Erectile Dysfunction. JAMA. 1999;282(10):939-941. doi:10-1001/pubs.JAMA-ISSN-0098-7484-282-10-jbk0908