Cooperative groups and community hospitals. Measurement of impact in the community hospitals

Begg, Colin B.; Zelen, Marvin; Carbone, Paul P.; McFadden, Eleanor; Brodovsky, Harvey; Engstrom, P.; Hatfield, Alan K.; Ingle, James N.; Schwartz, Burton; Stolbach, Leo L.

doi:10.1002/1097-0142(19831101)52:9<1760::aid-cncr2820520934>3.0.co;2-r

Cited by 42 publications

(21 citation statements)

References 3 publications

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“…13 Together, these and earlier studies consistently show that once a patient has access to cancer care, the absence of an available clinical trial precludes participation for about half of all patients. 14,21,22 …”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

“…Studies have found that a common reason for patient ineligibility to available protocols is narrow eligibility criteria. 3,14,21,22,23,24 Trial eligibility attempt to satisfy two opposing criteria. On the one hand, eligibility must be sufficiently narrow to produce a treatment effect that is approximately consistent across the cohort.…”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

“…13,14,20,21,22,27 The dominant reason for ineligibility exclusions is likely exclusions due to comorbid conditions. One recent paper comprehensively catalogued the trial eligibility criteria for a set of 21 trials in diverse cancer settings.…”

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

See 2 more Smart Citations

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Unger

Cook²,

Tai

et al. 2016

American Society of Clinical Oncology Educational Book

297

298

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OVERVIEW Fewer than 1 in 20 adult cancer patients enroll in cancer clinical trials. But although barriers to trial participation have been the subject of frequent study, the rate of trial participation has not changed substantially over time. Barriers to trial participation are structural, clinical, and attitudinal, and differ according to demographic and socioeconomic factors. In this paper, we characterize the nature of cancer clinical trial barriers, and we consider global and local strategies for reducing barriers. We also consider the specific case of adolescents with cancer, and show that the low rate of trial enrollment in this age group strongly correlates with limited improvements in cancer population outcomes compared to other age groups. Our analysis suggests that a clinical trial system that enrolls patients at higher rates produces treatment advances at a faster rate and corresponding improvements in cancer population outcomes. Viewed in this light, the issue of clinical trial enrollment is foundational, lying at the heart of the cancer clinical trial endeavor. Fewer barriers to trial participation would allow trials to be completed more quickly and would improve the generalizability of trial results. Moreover, increased accrual to trials is important to patients, since trials provide patients the opportunity to receive the newest treatments. In an era of increasing emphasis on a treatment decision-making process that incorporates the patient perspective, the opportunity for patients to choose trial participation for their care is vital.

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Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

Section: Understanding Barriers To Clinical Trial Participationmentioning

confidence: 99%

See 1 more Smart Citation

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

Unger

Cook²,

Tai

et al. 2016

American Society of Clinical Oncology Educational Book

297

298

View full text Add to dashboard Cite

show abstract

“…54 Although this may lead to the assumption that the treatment center has an influence on the treatment outcome, it has also been shown that within oncology trials, small community hospitals are able to generate treatment outcomes similar to the results obtained within large university hospitals. 53,[55][56][57][58] It is therefore more plausible that a difference in experience has influenced the relative favorable survival within specific hospitals, as it has been recognized that only a selection of hospitals participate in clinical trials. 1,59 Some older evidence exists on the capability of specialist centers to produce better treatment outcomes.…”

Section: Discussionmentioning

confidence: 99%

A review of recruitment criteria, patient characteristics and results of CHOP chemotherapy in prospective randomized phase III clinical trials for aggressive non-Hodgkin's lymphoma

Agthoven¹,

Sonneveld²,

Hagenbeek³

et al. 2003

Hematol J

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It has frequently been questioned whether results of trials can be generalized to routine clinical practice. Results obtained with standard cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy for aggressive non-Hodgkin's lymphoma in the control arm of prospective randomized phase III clinical trials during the past 25 years appear to be comparable. As the possibility to generalize trial results is favored by such consistency, we tested this hypothesis and tried to indicate explanatory 'moderator variables' (inclusion and exclusion criteria, therapy characteristics, sample sizes, inequalities in the distribution of patients over prognostic categories across different trials) in the case of divergent trial results. Trial results on conventional CHOP chemotherapy were obtained from literature research. Overall response (OR), complete response (CR) and two-year overall survival (2YS) were considered as outcome measures. Although OR rates and 2YS rates were within acceptable limits of comparability, the absolute differences within the results were remarkably wide, particularly with regard to CR and 2YS. Divergent rates could not be properly explained by differences in the moderator variables. We conclude that absolute results obtained with CHOP in the control arm of trials appeared to be poorly generalizable to routine clinical practice, particularly in the case of elderly patients. This analysis underlines the need for the strict application of internationally agreed response criteria and the WHO classification system, large sample sizes and stratifying patients on the basis of prognostic factors, preferably in intergroup clinical trials. We expect those factors to lead to a better consistency of results in future trials and improved possibilities to generalize the results.

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“…The referral base for this tertiary referral center comes from a five-state region of approximately 7 million persons. At this site, 17 Women eligible for this study were those diagnosed with breast cancer within the last 6 months and were selected from tumor registry data at each institution. Samples of trial-eligible and ineligible women from each site were identified.…”

Section: Subjectsmentioning

confidence: 99%

Participation in Clinical Treatment Trials: Factors Affecting Participation for Women with Breast Cancer

Paskett¹,

Muss²,

Case³

et al. 1996

Journal of Women's Health

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A retrospective descriptive study was conducted to investigate reasons for participation or nonparticipation in clinical treatment trials among women with breast cancer. Eighty-two breast cancer patients from a university-based medical center (h = 40) and a rural community hospital (« = 42) were selected from hospital tumor registry records. Thirty-minute face-to-face interviews were conducted to identify reasons for participation or nonparticipation in clinical treatment trials. Those who were not asked initially to participate in a trial (either because of trial unavailability or ineligibility or because they simply were not asked) were also asked if they would have participated had they been invited. Thirty-four (41%) were eligible for participation in one or more of the currently ongoing clinical trials. Only 20 (59%) of these women were invited to participate in a treatment trial by their physician. Of those asked, 14 (70%) agreed to participate. The majority of women who were not invited or not eligible stated that they would have participated if invited (50% of those not invited and 70% of those not eligible). Reasons for participation included personal benefit, altruism, doctor's recommendation, desire to foster the progress of medical research, and previous experience with cancer or medical research. Reasons women gave for not wanting to participate included negative beliefs about clinical trial research, lack of knowledge about clinical trial research, personal issues, and requirements of the protocol. Among eligible women, those who were not offered trial participation were older than those offered participation (average age 63 years vs. 54 years; p = 0.025). Logistic regression analysis identified two areas that predicted participation: knowledge about research studies (OR = 3.98; p = 0.05) and attitudes about research studies (OR = 3.6; p = 0.03). Working status, cancer detected by a physician, and knowledge of signs and symptoms of cancer were modestly associated with participation. Three areas of intervention were identified that would foster clinical trial participation for breast cancer: (1) protocols need to be designed with broader eligibility criteria or more protocols need to be written, (2) physicians should be encouraged to invite all eligible patients to participate, and (3) knowledge and attitudes of patients regarding clinical trials need to be improved.

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Cooperative groups and community hospitals. Measurement of impact in the community hospitals

Cited by 42 publications

References 3 publications

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

A review of recruitment criteria, patient characteristics and results of CHOP chemotherapy in prospective randomized phase III clinical trials for aggressive non-Hodgkin's lymphoma

Participation in Clinical Treatment Trials: Factors Affecting Participation for Women with Breast Cancer

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