1. Current
trial designs provide insight into how research leaders interpret
available research data on evolving treatment strategies.
The control arms of these studies are a commentary on what is
considered "standard," and the experimental arms provide
clues as to what might be expected in the future.
2. Understanding
the research questions being addressed prepares clinicians for
the next generation of clinical trial results.
The evolution of independent external data monitoring committees
sometimes leads to the seemingly precipitous dissemination of
early trial results, which can be challenging to implement into
clinical care unless there is prior familiarity with trial designs
and objectives.
A good example
was the sudden release in 1998 of initial data from NSABP P-1,
the "Tamoxifen Prevention Trial." Clinicians and researchers
who were unfamiliar with the entry criteria and objectives for
this study suddenly had to integrate a somewhat complex data set
into clinical practice, but physicians who had participated in
this trial were already well-positioned to understand its clinical
implications.
3. All
cancer patients deserve the opportunity to participate in clinical
research.
A disappointing three percent of breast cancer patients are enrolled
in clinical trials, although about half are interested in participation
when asked. As noted by SWOG, enrollment of elderly women is particularly
problematic.
Participation
in clinical trials offers patients and physicians many well-documented
advantages, including assurance that treatment and follow-up are
state-of-the-art, and the gratification that comes with helping
move the field forward.
Peto's estimate
of 10,000 lives saved annually means that everyday, in the United
States alone, about 25 women will be alive and well, who would
have died without the seemingly modest but humanly important advances
that have been made in diagnosis and treatment of breast cancer
in the last two decades.
A closer look
at the core of this encouraging trend is the emergence of large-scale
randomized clinical trials that demonstrated the benefits of screening
mammography and adjuvant systemic therapy. In essence, thousands
of patients and healthcare professionals have together woven a
new set of lifesaving standards through clinical research.
A decade
or two from now, attendees at this meeting will likely be reading
about the results of the current trials listed in this book and
in the educational exhibit, and hopefully a new generation of
patients will be alive and well as a result.
-Neil
Love, MD
