Shortcomings of randomized trials have long been recognized by medical researchers
[
1
,
2
]. These shortcomings include a reduced range of risk factors for the outcome among
patients enrolled in preapproval trials. The reduced range enhances the validity of
the trials, but the patient populations are highly selected compared with the broad
range of risk factors represented among patients who are eventually treated with the
drug. This restriction may reduce the generalizability of the findings from those
studied to those with different baseline risks.To read this article in full you will need to make a payment
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Article info
Publication history
Published online: January 07, 2008
Accepted:
July 12,
2007
Identification
Copyright
© 2008 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
