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Supplement: Section 1
RESEARCH
LEADER COMMENTS ON BREAST CANCER CLINICAL TRIALS
Arguably
one of the most important advances during the last 50 years has
been the introduction of prospectively randomized controlled trials
to clinical medicine. Such trials provide information about the
natural history of a disease and evaluate the worth of a particular
therapy. Moreover, they allow for testing of biological hypotheses
and, thus, provide a mechanism whereby the scientific method can
be applied to clinical problem solving. ... By replacing anecdotal
information (which has influenced therapeutic decision-making in
the past) with more credible and substantive data, clinical trials
play a major role in transforming the practice of medicine from
an art to a science.
... As a
vital component of the "research chain" clinical trials
are an essential link between the laboratory and the clinic, providing
means for determining whether the use of laboratory findings in
the treatment of patients is justified. ...Without trials, much
of the scientific information currently being reported could not
be evaluated for its therapeutic worth. When properly employed,
clinical trials supply definitive information about the value of
therapies before their widespread use. ...
Appropriately
conducted trials require participation by investigators, clinicians
and statisticians who adhere to standards that are just as exact
as those used in laboratory experiments or in complex surgical procedures.
... Unfortunately, every study contains unknown factors that can
also affect the findings, and to minimize their effect, every effort
must be made to ensure that these putative factors are equally distributed
among the groups of patients being compared. In clinical trials,
this goal is accomplished through the process of randomizing large
numbers of patients to eliminate any biases, overt or covert, that
might influence the study findings.
-
Bernard Fisher, MD
News from the Commission on Cancer
of the American College of Surgeons 1991;2(2).
The randomised
controlled trial has become the gold standard for evidence-based
medicine; through the unbiased comparison of competing treatments
it is possible to accurately quantify the cost-benefits and harm
of individual treatments. This allows clinicians to offer patients
an informed choice and provides the data on which purchasing authorities
can make financial decisions.
We, of course,
subscribe to this view but also recognize this as a gross oversimplification
of the power of the randomised controlled trial. The randomised
controlled trial is the expression of deductive science in clinical
medicine. Not only is it the most powerful tool we have for subjecting
therapeutic hypotheses to the hazard of refutation but also the
biological fallout from such trials should allow clinical scientists
to refine biological hypotheses.
Trials of
treatments for breast cancer have, at least twice, contributed substantially
to a paradigm shift in our understanding of the disease.
-
Michael Baum, ChM, FRCS; Joan Houghton, BSc
Br Med J 1999;319:568-571.
There are
thousands of randomized trials in the world, which will lead to
"zigs and zags" in the data. And, the "zags"
are probably the ones that are going to be the most noteworthy and
the most emphasized in meetings, because they look odd. They look
surprising. Why are you going to present your trial at a meeting?
What, another tamoxifen trial? We've had about 50 or 60 of them
already. Why present it? Because the results look unusual.
So if you
take lots of trials and then pick out the ones where the results
look out of line with the other ones, then you're quite likely to
have something that is misleading. And if you split the patients
up in various ways and looked at each little subgroup of patients,
you're going to get something even more freaky in some subgroup
or other. And then that will get picked up and emphasized, and everyone
can write press releases and circulate them around, and you can
finish up in the newspapers with your results. It's not a good way
to obtain reliable answers.
You've got
to systematically bring together all the evidence in the world -
look at it irrespective of what the individual study shows - see
what the grand total looks like, and then you've got something reliable.
We've seen too many trial results that are odd things, that prove
to be evanescent. It happens again and again, and then the next
trial that comes out points you in the opposite direction, and then
you say, "Now what?" But if you put all of the trials
together, then you get reliable knowledge. If you don't, you don't.
-
Richard Peto, FRS
NCI
LAUNCHES RESTRUCTURING OF DEVELOPMENT, REVIEW, CONDUCT AND
SUPPORT OF CLINICAL TRIALS
In 1997,
the NCI's Clinical Trials Program Review Group, chaired by
Dr James Armitage, released recommendations to revamp the
clinical trials system. These recommendations were translated
into a working plan in 1998 by co-chairs of the Clinical Trials
Implementation Committee, Dr John Glick and Dr Michaele Christian.
The primary
goal of this new system is to rapidly accelerate the pace
of clinical cancer research by enabling all US oncologists
to offer patients NCI-sponsored clinical trials and by simplifying
and standardizing paperwork and procedures related to these
trials. New features of the NCI clinical trials program include
standardization of data collection and online data reporting,
simplified informed consent and a centralized IRB process.
To make open access to trials feasible, the NCI will establish
clinical trial support units (CTSUs) to implement a uniform
system of patient registration and data collection for all
trials in the Network. To facilitate all aspects of protocol
generation and trials conduct, a modernized informatics system
for clinical trials will also be developed.
Cancer
Clinical Trials: A New National System Web
link
Cancer
Trials Support Unit Web
link
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