|
|
|
|
|
|
|
|
|
|
open access - article
To the Editor:
Most phase III randomized clinical trials
(RCT) in oncology are designed to change clinical practice by
convincingly demonstrating
whether a new (often toxic) treatment provides
meaningful improvement in outcome relative to an active standard
treatment
or best supportive care. To protect patients and
resources, RCTs should use formal interim monitoring so that trials can
be
stopped early once the study question has been
answered. Accordingly, in addition to stopping for convincing evidence
of new
treatment benefit, futility/inefficacy (lack of
benefit) interim monitoring should be included to allow an RCT to be
stopped
if it becomes clear that the new treatment is
unlikely to provide tangible improvement. In particular, to demonstrate
lack
of benefit, there is no need to establish that a
new treatment is significantly worse than the control treatment;
instead,
ruling out meaningful benefit is sufficient to
address the study goal while maintaining a proper balance between
patient interests
and the need to acquire scientific evidence.1,2
Vergote et al3 report an RCT in patients with ovarian carcinoma and no progression after first-line chemotherapy; the study evaluated the
addition of 2 years of erlotinib maintenance treatment versus observation.......open access - response
0 comments :
Post a Comment
Your comments?
Note: Only a member of this blog may post a comment.