Clinical trial accrual in older cancer patients: The most important steps are the first ones

6041 Background: Most cancer patients are diagnosed and treated in the community but clinical trial accrual rate is low. Published data on trial accrual from community-based cancer centers throughout the U.S. are limited. The Association of Community Cancer Centers (ACCC) is a national multidisciplinary education and advocacy organization that maintains a membership caring for over 60% of all patients with cancer in the U.S. In order to determine the clinical trial accrual patterns in the community across various geographic regions in the U.S., we performed a retrospective study utilizing the data from ACCC membership maintained at their web site. Methods: Data available from the most recent year (2003–2005) were obtained from 621 centers throughout the U.S., representing 49 states (no data for WY) and the DC. We investigated the number of patients (new and old) accrued into trials per year relative to the number of new analytical patients seen in the same year, a value we termed accrual ratio (AR). In addition, we studied the effects of geographic location, size of the cancer program, number of affiliations with National Cancer Institute sponsored cancer cooperative groups, and the number of medical/support/data management staffs on trial accrual. Results: A total of 670,215 new patients were seen across the ACCC membership with 43,743 patients accrued into trials for a median AR of 6.5% (range, 0.3–16.9). The top and bottom 5 accruing states were VT, MD, SD, LA, ID and KS, ND, VA, NH, AR, respectively. Regionally, the AR for Midwest, Middle Atlantic, West, South, Southwest, and New England were as follows: 7.4%, 7.0%, 6.2%, 6.0%, 5.7%, and 5.4% (p < 0.001). One hundred (16.1%) centers representing 11.8% of all new patients were not affiliated with any of the cooperative groups. This group had the lowest AR (3.1%). AR increased when centers were affiliated with more cooperative groups (p < 0.001) or cared for more new patients (p < 0.001). The number of medical, support, and data management staffs did not influence accrual. Conclusions: Overall, clinical trial accrual in the U.S. community cancer centers is low. Accrual patterns differed significantly among various geographic locations. Better access to trials is needed in order to improve participation of cancer patients. No significant financial relationships to disclose.

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Clinical trial accrual among new cancer patients at a community-based cancer center

Cancer ◽

10.1002/cncr.21597 ◽

2006 ◽

Vol 106 (2) ◽

pp. 426-433 ◽

Cited By ~ 78

Author(s):

Ronald S. Go ◽

Kathleen A. Frisby ◽

Jennifer A. Lee ◽

Michelle A. Mathiason ◽

Christine M. Meyer ◽

...

Keyword(s):

Clinical Trial ◽

Cancer Patients ◽

Cancer Center ◽

Community Based ◽

Clinical Trial Accrual

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03 / UNDER REPORTING OF CLINICAL TRIAL DATA FOR OLDER CANCER PATIENTS: A SYSTEMATIC REVIEW

10.26226/morressier.5afadd8af314ac000849b020 ◽

2018 ◽

Author(s):

Karlynn BrintzenhofeSzoc

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Cancer Patients ◽

Clinical Trial Data ◽

Trial Data ◽

Older Cancer Patients

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Perceptions of clinical trial participation between community practitioners and older cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2004.22.14_suppl.8260 ◽

2004 ◽

Vol 22 (14_suppl) ◽

pp. 8260-8260 ◽

Cited By ~ 1

Author(s):

J. T. Tam ◽

J. Payne ◽

B. Teplitzky ◽

W. Ershler ◽

L. Balducci

Keyword(s):

Clinical Trial ◽

Cancer Patients ◽

Trial Participation ◽

Clinical Trial Participation ◽

Older Cancer Patients

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Clinical Trial Design for Older Cancer Patients

Encyclopedia of Gerontology and Population Aging ◽

10.1007/978-3-319-69892-2_763-1 ◽

2020 ◽

pp. 1-7

Author(s):

Roman Dubianski ◽

Hans Wildiers

Keyword(s):

Clinical Trial ◽

Cancer Patients ◽

Trial Design ◽

Clinical Trial Design ◽

Older Cancer Patients

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Perceptions of clinical trial participation between community practitioners and older cancer patients

Journal of Clinical Oncology ◽

10.1200/jco.2004.22.90140.8260 ◽

2004 ◽

Vol 22 (14_suppl) ◽

pp. 8260-8260

Author(s):

J. T. Tam ◽

J. Payne ◽

B. Teplitzky ◽

W. Ershler ◽

L. Balducci

Keyword(s):

Clinical Trial ◽

Cancer Patients ◽

Trial Participation ◽

Clinical Trial Participation ◽

Older Cancer Patients

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Reporting of clinical trial data: Are we fully utilizing the current clinical trial data to help manage the older adult cancer population?

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19546 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19546-19546

Author(s):

J. T. Tam-McDevitt ◽

W. Tew ◽

S. Klapper ◽

R. Hauser ◽

S. Lichtman

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Treatment Options ◽

Clinical Trial Data ◽

Trial Data ◽

Discussion Section ◽

Age Related ◽

Number Of Patients ◽

Older Cancer Patients

19546 Background: The number of older cancer patients will continue to increase as the population ages. Thus the demand for information on how to manage this population will continue to increase in importance. Clinical trials provide pertinent information to clinicians on treatment options, however, are the current available results matching the needs for the older cancer population? Methods: An evaluation was performed of published clinical trials to determine whether the data was analyzed, reported and discussed using age related criteria. Prospective studies involving 50 or more patients published from 01/2005–12/2006 in the Journal of Clinical Oncology (JCO), Cancer, and the Journal of the National Cancer Institute (JNCI) were reviewed. Results: There were 258 JCO, 58 Cancer, and 17 JNCI articles with the prespecified criteria. The median number of patients enrolled per trial is 212 (JCO), 77.5 (Cancer), and 954 (JNCI). The mean age of patients enrolled for all studies was 59.4 years (range 16 to 93 years). The number (%) of studies which stratified for age is 54 (20.9%) for JCO, 17 (29.3%) for Cancer, and 7 (41%) for JNCI. The number (%) of studies which included age in their analyses is 75 (29%) for JCO, 14 (24%) for Cancer, and 6 (35.3%) for JNCI. Age was mentioned in the discussion section in 40 (15.5%), 8 (13.8%), and 6 (35.3%), JCO, Cancer, and JNCI articles, respectively. Conclusions: The current clinical trials fail to provide ample data which clinicians need to best manage the older cancer population. Since there was a lack of age related analyses, valuable data may have gone unreported. ASCO and other organizations recognize the lack of data on the management of older cancer patients. The underrepresentation of this population in clinical trials certainly contributes to this lack of data. Data mining of these existing studies involving large numbers of patients may provide valuable age related information for clinicians. The continued development of trials involving the older cancer population will aid in increasing our knowledge. We would also like to put forth that journal reviewers and editors should require the incorporation and reporting of age related analyses in studies, especially those involving large number of patients. No significant financial relationships to disclose.

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Barriers to clinical trial accrual in a community cancer clinic.

Journal of Clinical Oncology ◽

10.1200/jco.2014.32.30_suppl.91 ◽

2014 ◽

Vol 32 (30_suppl) ◽

pp. 91-91

Author(s):

Cheruppolil R. Santhosh-Kumar

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Cancer Patients ◽

Community Setting ◽

Care Quality ◽

Rural Setting ◽

Trial Participation ◽

Trial Process ◽

Clinical Trial Accrual ◽

Cancer Clinic

91 Background: The availability of and enrollment in clinical trials at an institution may be considered cancer care quality measures. Nationally, most cancer patients are initially diagnosed and treated in the community setting. Data regarding clinical trial accrual of new cancer patients from community-based cancer centers and the barriers they encounter are limited. We sought to identify potential barriers to enrollment in clinical trials at a community cancer clinic. Methods: Data on new cancer patients seen at our comprehensive community cancer clinic were prospectively collected from 2007 through 2010. Factors that potentially affected patient accrual in clinical studies were tracked. Results: During the four-year study period, a total of 662 patients were diagnosed with breast, prostate, colon, lung, gynecological, melanoma and renal cell cancers. No studies were available for 42% of the patients (n=278). Of the remaining patients, 49% (190/384) met protocol eligibility. Of the eligible study patients, 45% (85/190) enrolled, for an overall accrual rate of 13% (85/662), and 55% (105/190) declined participation. Patients declined to participate due to stress of diagnosis, refusal of treatment entirely, issues with randomization and placebo, concerns with side effects of the medications, delay of treatment while awaiting the clinical trial process, patient refusal, transportation concerns and length of treatment. Conclusions: This study demonstrates that above average clinical trial participation can be achieved in community cancer clinics in the rural setting. There are modifiable barriers to clinical trial accrual including study availability, patient eligibility and other patient factors. Improvement of patients’ perceptions and perspectives regarding the clinical trial process could be achieved through patient education. Elimination of barriers to trial accrual could be studied as a quality metric.

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