NcXHF

WILLIAM M. SIKOV
gational treatment is on trial, such as in the adjuvant trastuzumab
studies. Would it not be easier if consent forms were not
20 or more pages long, with interminable lists of potential (if
rare) side effects? Do we really expect our patients to read and
comprehend such a lengthy document, even if (supposedly)
written at an eighth-grade level?
So what can or should we do about the direction of the U.S.
clinical trials system? I agree with those who have spoken in
favor of a publicly funded clinical trials system, 3,8 and I do not
expect or want the NCI leadership to reverse direction on the
value of precision medicine trials. Although that initiative is
important, I would like to believe that we can walk and chew
gum at the same time; that is, conduct those smaller-focused
studies without relinquishing the ability to pose pertinent
questions that require much larger trials to answer. So we
should lobby our congresspeople and senators to increase
funding to the National Institutes of Health that is earmarked
to the cancer clinical trials program, perhaps even specifıed
to go toward larger trials, some of which may be designed to
determine if we can reduce the toxicity and cost of treatment
without reducing its effıcacy. We could make the argument
that a relatively small investment in such studies could potentially
save the system a great deal more. As an alternative
to government spending, we should encourage philanthropies
like the Conquer Cancer Foundation to consider trying
to enlarge their donor base by offering individuals and foundations
the opportunity to step into this gap and help fund
large, simple trials that address important questions. Such
trials could be run on, relatively speaking, a shoestring budget,
with sites making up for low per-case funding with
higher accrual, and reducing costs by collecting only key outcomes
and toxicity data and minimizing costs by holding
study group meetings via the Web.
We could even explore creating a virtual tissue bank, where
samples are held at the treating institutions and sent to a designated
research facility only when requested.
It boils down to understanding the importance of your role
as the patient’s physician and advocate, even if it is the fırst
time you have met. If you truly believe that participating in the
study could be her best option, you can also acknowledge that
an important reason why you take the time to do this is so that
when you, or another physician, perhaps even that resident, sit
down with a patient like her in 5, 10, or 20 years you will be
able to say whether treatment A is better, equivalent to, inferior
to, or less or more toxic, than treatment B. In the end,
when the results of this study have been presented and published,
you can both be proud to have been part of the process.
That is, assuming you still have suffıcient access to trials to
offer to her and your other patients.
Disclosures of Potential Conflicts of Interest
Relationships are considered self-held and compensated unless otherwise noted. Relationships marked “L” indicate leadership positions. Relationships marked “I” are those held by an immediate
family member; those marked “B” are held by the author and an immediate family member. Institutional relationships are marked “Inst.” Relationships marked “U” are uncompensated.
Employment: None. Leadership Position: None. Stock or Other Ownership Interests: None. Honoraria: William Sikov, Bristol-Myers Squibb. Consulting
or Advisory Role: William Sikov, Celgene, AbbVie. Speakers’ Bureau: None. Research Funding: None. Patents, Royalties, or Other Intellectual
Property: None. Expert Testimony: None. Travel, Accommodations, Expenses: None. Other Relationships: None.
References
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on patients’ decision making on participation in clinical trials.
J Clin Oncol. 2008;26:2666-2673.
2. Comis RL, Miller JD, Aldigé C, et al. Public attitudes toward participation
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3. Schilsky RL. Wither the cooperative groups? J Clin Oncol. 2014;32:251-
254.
4. National Research Council. A National Cancer Clinical Trials System for
the 21st Century: Reinvigorating the NCI Cooperative Group Program.
Washington, DC: The National Academies Press; 2010.
5. Meropol NJ, Buzaglo JS, Millard J, et al. Barriers to clinical trial participation
as perceived by oncologists and patients. J Natl Compr Canc
Netw. 2007;5:655-664.
6. Abrams J, Kramer B, Doroshow JH, et al. National Cancer Institutesupported
clinical trials networks. J Clin Oncol. Epub 2014 Dec 1.
7. Greenwood A. Taking action to diversify clinical cancer research. NCI
Cancer Bulletin. 2010;7(10). http://www.cancer.gov/ncicancerbulletin/
051810/page7. Accessed April 7, 2015.
8. Tempero M. A publicly funded clinical trials network: Do we need it?
J Natl Compr Canc Netw. 2014;12:953.
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