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Clinical Trial Information As a Measure of Quality Cancer Care

Authors:
Wei Chua at NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors
Wei Chua
Stephen J Clarke at Northern Sydney Local Health District, Sydney, Australia
Stephen J Clarke
  • Northern Sydney Local Health District, Sydney, Australia
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Abstract

Participation in clinical trials enables patients to access new treatment options. Evidence shows improved outcomes in participants compared with nonparticipants in non-small-cell, lung, breast, colorectal, and testicular cancers.
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Clinical Trial Information As a Measure of Quality
Cancer Care
By Wei Chua, MBBS, and Stephen J. Clarke, MBBS, PhD
Department of Medical Oncology, Sydney Cancer Centre, Concord Repatriation General Hospital, Sydney, New South
Wales, Australia
There is an increasing need to develop and improve quality
indicators in oncology. Recent initiatives to improve the quality
of care of patients with cancer have included the National Ini-
tiative on Cancer Care Quality promoted by ASCO and the
Quality Oncology Practice Initiative, a practice-based system of
quality self-assessment sponsored by the participants and
ASCO, the results of which have been presented in Journal of
Oncology Practice.
1-3
In colorectal cancer (CRC), the Duke Ev-
idence-Based Practice Center (Duke University School of Med-
icine, Durham, NC) prepared a comprehensive report to
identify measures currently available to assess the quality of care
provided to patients with CRC and the extent to which these
measures had been developed and tested.
4
Examples of well-
developed measures included the percentage of patients who
underwent appropriate evaluation for a positive fecal occult
blood test and adequate lymph node retrieval at surgery. Qual-
ity measures in medical oncology were lacking, particularly
those used to assess use of palliative chemotherapy for patients
with stage IV CRC.
Clinical trial units should be an integral part of cancer cen-
ters. Participation in clinical trials enables patients to access new
treatment options; there is increasing evidence of improved
patient outcomes from participation in clinical trials compared
with noninvolved patients in non–small-cell lung, breast, colo-
rectal, and testicular cancers.
5-9
Recently, ASCO described both
minimum requirements for a site conducting quality clinical
trials and attributes of exemplary sites as a guide to oncologists
wishing to conduct high-quality research programs that comply
with the International Conference and Harmonisation Good
Clinical Practice Guidelines.
10
Consensus statements by
ASCO, the American Federation of Oncological Services, and
the European Society for Medical Oncology have listed patient
access and opportunity to participate in relevant clinical trials as
basic requirements of quality cancer care.
11,12
In Australia, the
National Health and Medical Research Council guidelines for
the prevention, early detection, and management of CRC rec-
ommend that eligible patients consider participation in appro-
priate clinical trials.
13
However, a survey on chemotherapy
management in Australia found that 46% of patients treated by
medical oncologists were not taking part in any trial, 12% were
considered to be eligible for a trial, and only 8% were partici-
pating in one.
14
High accrual activity to clinical trials has been
used as an example of a goal of an exemplary clinical research
site, with the recommendation to accrue at least 10% of patients
to clinical trials.
14
The recognition of the importance of clinical trial participa-
tion coupled with the need for appropriate quality indicators in
medical oncology makes clinical trial activity an attractive op-
tion as a performance indicator. We propose that information
from a clinical trial unit in an individual cancer center may be
used in a manner that is useful to reflect the quality of care
available. Response rates and survival are often the main efficacy
end points in cancer chemotherapy trials; however, their use as
quality indicators would be problematic because of heterogene-
ity and variability in clinical trials.
Appropriate measures that may allow for some degree of
comparison among units include the quality measure domains
of (1) number and type of clinical trials available, (2) patient
enrollment onto clinical trials, (3) initial therapeutic manage-
ment, (4) patient preference and inclusion in decision making,
and (5) management of treatment toxicity. These have been
previously identified by the National Initiative on Cancer Care
Quality.
2
As an example, the type of clinical trials available may
be categorized as biomarker, early- or late-phase drug develop-
ment, or nonpharmaceutical quality-of-life trials and subclassed
according to tumor type. It is not feasible for each cancer site to
have active clinical trials in each of these categories, and differ-
ences in practice site, patient mix, and demographics should be
taken into account. However, it would not be unreasonable to
compare the number of first-line phase III randomized clinical
trials available to patients in two cancer centers serving similar
population sizes with similar resources. Other measure do-
mains, such as the number of patients enrolled onto clinical
trials against the total number of new patients in a specified
period, may provide a crude estimate of the functioning of a
clinical trial unit. However, not all patients meet the strict in-
clusion criteria of clinical trials, and more sophisticated mea-
sures may be necessary. As an example, the number of patients
enrolled onto clinical trials (numerator) against those eligible
for participation in one (denominator) may provide a better
indicator of the activity of a clinical trial unit. In addition,
documentation of toxicity management for patients enrolled
onto clinical trials, including grade 3 or 4 severe toxicities, and
number and length of hospitalizations secondary to toxicity for
similar phase III trials may be other examples.
In summary, we propose use of clinical trial information and
suggest aspects of this that may serve as quality indicators in
medical oncology. The quality measures proposed are not ex-
haustive and require refinement; some of them may be inappro-
priate depending on local practices and health service delivery.
Perspective
170 JOURNAL OF ONCOLOGY PRACTICE •VOL.6,ISSUE 3Copyright © 2010 by American Society of Clinical Oncology
However, the concept presented is hypothesis generating. We
are optimistic that this novel concept may stimulate healthy and
open debate toward using clinical trial information for standard
comparisons among cancer units to improve cancer care deliv-
ery. There is an increasing need for greater accountability and
improvement of care in medical oncology, and development of
such quality indicators is necessary. More controversially, it
may be argued that public reporting of such performance indi-
cators will be of even greater importance in the future as both
public and private payment systems continue to develop.
Accepted for publication on March 24, 2010.
Authors’ Disclosures of Potential Conflicts of Interest
The authors indicated no potential conflicts of interest.
Author Contributions
Conception and design: Wei Chua, Stephen J. Clarke
Collection and assembly of data: Wei Chua, Stephen J. Clarke
Data analysis and interpretation: Wei Chua, Stephen J. Clarke
Manuscript writing: Wei Chua, Stephen J. Clarke
Final approval of manuscript: Wei Chua, Stephen J. Clarke
DOI: 10.1200/JOP.091099
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MAY 2010 • jop.ascopubs.org 171Copyright © 2010 by American Society of Clinical Oncology
... Cancer Care. Trial participation is increasingly seen as part of routine care for cancer patients, with many health systems seeking to increase participation and with some using it as a measure of the quality of care (11). While there are schemes in some health systems to allow patients special access (e.g., Therapeutic Goods Administration, 2015) (12), patients may see enrolment in a trial as a way to gain early access to new treatments. ...
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