Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Jan 10;28(2):215-21.
doi: 10.1200/JCO.2008.21.3652. Epub 2009 Nov 23.

Differences in clinical trial patient attributes and outcomes according to enrollment setting

Elizabeth B Lamont  1 , Mary Beth Landrum, Nancy L Keating, Laura Archer, Lan Lan, Gary M Strauss, Rogerio Lilenbaum, Harvey B Niell, L Herbert Maurer, Michael P Kosty, Antonius A Miller, Gerald H Clamon, Anthony D Elias, Edward F McClay, Everett E Vokes, Barbara J McNeil
Affiliations

Differences in clinical trial patient attributes and outcomes according to enrollment setting

Elizabeth B Lamont et al. J Clin Oncol. .

Abstract

Purpose: During the last 25 years, National Cancer Institute (NCI) cooperative trial groups have extended trial networks from academic centers to include certain community and Veterans Health Administration (VHA) centers. We compared trial patients' attributes and outcomes by these enrollment settings.

Patients and methods: Studying 2,708 patients on one of 10 cooperative group, randomized lung trials at 272 institutions, we compared patient attributes by enrollment setting (ie, academic, community, and VHA affiliates). We used adjusted Cox regression to evaluate for survival differences by setting.

Results: Main member institutions enrolled 44% of patients; community affiliates enrolled 44%; and VHAs enrolled 12%. Patient attributes (ie, case-mix) of age, ethnicity, sex, and performance status varied by enrollment setting. After analysis was adjusted for patient case-mix, no mortality differences by enrollment setting were noted.

Conclusion: Although trial patients with primarily advanced-stage lung cancer from nonacademic centers were older and had worse performance statuses than those from academic centers, survival did not differ by enrollment setting after analysis accounted for patient heterogeneity. An answer for whether long-term outcomes for patients at community and VHA centers affiliated with cooperative trial groups are equivalent to those at academic centers when care is delivered through NCI trials requires additional research among patients with longer survival horizons.

PubMed Disclaimer

Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Comment in

References

    1. Elting LS, Cooksley C, Bekele BN, et al. Generalizability of cancer clinical trial results: Prognostic differences between participants and nonparticipants. Cancer. 2006;106:2452–2458. - PubMed
    1. Verheggen FW, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: Why patients enter a clinical trial. Patient Educ Couns. 1998;35:111–125. - PubMed
    1. Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20:2109–2117. - PubMed
    1. Hutchins LF, Unger JM, Crowley JJ, et al. Underrepresentatation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061–2067. - PubMed
    1. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA. 2004;291:2720–2726. - PubMed

Publication types