Analysis of Maryland Cancer Patient Participation in National Cancer Institute–Supported Cancer Treatment Clinical Trials

Purpose We examined the relationship of sociodemographic factors, urban/rural residence, and county-level socioeconomic factors on accrual of Maryland patients with cancer to National Cancer Institute (NCI) –sponsored cancer treatment clinical trials. Patients and Methods Data were analyzed for the period 1999 to 2002 for 2,240 Maryland patients with cancer accrued onto NCI-sponsored treatment trials. The extent to which Maryland patients with cancer and patients residing in lower socioeconomic and/or rural areas were accrued to cancer trials and were representative of all patients with cancer in Maryland was determined. Data were obtained from several sources, including NCI's Cancer Therapy Evaluation Program for Maryland patients with cancer in Cooperative Group therapeutic trials, Maryland Cancer Registry data on cancer incidence, and United States Census and the Department of Agriculture. Results For Maryland patients with cancer accrued onto NCI-sponsored treatment trials between 1999 and 2002, subgroups accrued at a higher rate included pediatric and adolescent age groups, white patients, female patients (for sex-specific tumors), patients with private health insurance, and patients residing in the Maryland National Capitol region. Moreover, between 1999 and 2002, there was an estimated annual decline (8.9% per year; P < .05) in the percentage of black patients accrued onto cancer treatment trials. Logistic regression models uncovered different patterns of accrual for female patients and male patients on county-level socioeconomic factors. Conclusion Results highlight disparities in the accrual of Maryland patients with cancer onto NCI-sponsored treatment trials based on patient age, race/ethnicity, geography of residence, and county-level socioeconomic factors. Findings provide the basis for development of innovative tailored and targeted educational efforts to improve trial accrual, particularly for the underserved.

Download Full-text

Racial disparities in access to prostate cancer clinical trials: A county-level analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.6553 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 6553-6553

Author(s):

Aasthaa Bansal ◽

Wei-Jhih Wang ◽

Caroline Savage Bennette ◽

Scott David Ramsey

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Cancer Treatment ◽

Cancer Clinical Trials ◽

County Level ◽

Prostate Cancer Treatment ◽

Cancer Trial ◽

Treatment Trials ◽

Per Capita ◽

The Relationship

6553 Background: African American men (AAs) have a higher burden of prostate cancer compared to other populations. We sought to determine if they experience disparities in access to prostate cancer clinical trials. Methods: We created a county-level database of all U.S. counties by linking together prostate cancer clinical trial data from the Aggregate Analysis of ClincalTrials.gov (AACT) database with county-level socioeconomic, demographic and healthcare facility data derived from several external data sources. Using this data linkage, we examined two specific potential access barriers. First, we investigated the relationship between %AAs in the county and access to NCI designated cancer facilities, adjusting for county population size and other characteristics. Then, among counties with cancer facilities, we investigated the relationship between the %AAs in the county and number of available prostate cancer treatment trials per capita per year. We used logistic and negative binomial regression models, respectively, to address these questions. Results: Between 2008 and 2015, 613 prostate cancer trial sites were found among 3,145 U.S. counties. Counties with higher %AAs were less likely to have cancer facilities (adjusted odds ratio = 0.85, 95% CI (0.78, 0.92)). Among counties with cancer facilities, those with higher %AAs had significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in %AAs: 0.90, 95% CI (0.83,0.96)), after adjusting for county-level sociodemographic and healthcare system factors. Conclusions: Counties with higher proportions of AAs appear to be less likely to have access to NCI designated cancer facilities. Among counties with cancer facilities, those with higher proportions of AAs appear to have fewer available prostate cancer treatment trials per capita per year. Clinical trials in prostate cancer therapy should ensure adequate availability of enrollment sites in regions with high concentrations of AAs.

Download Full-text

Effect of 9–11 on U.S. national cancer clinical trials accrual and lack of effect of National Cancer Institute budget increases

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.6551 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 6551-6551 ◽

Cited By ~ 1

Author(s):

A. Bleyer

Keyword(s):

Clinical Trials ◽

Cancer Treatment ◽

Cancer Patients ◽

National Cancer Institute ◽

Age Groups ◽

Cooperative Groups ◽

Treatment Trials ◽

The Past ◽

Beneficial Impact ◽

The Impact

6551 Background: During the past decade, a variety of initiatives have been implemented to improve the accrual of cancer patients on clinical trials. In the U.S., these have included comprehensive reviews and recommendations by the two most recent National Cancer Institute (NCI) administrations, reorganization of the clinical trials infrastructure at the NCI, and campaigns by the NCI Cooperative Groups and their Coalition. During the past six years, additional funds were allocated to this effort as part of the doubling of the NCI budget. The impact of these efforts on national cancer treatment clinical trials was evaluated, with emphasis on age groups. Methods: Accrual data from NCI-sponsored treatment trials conducted between 1997 and 2006 were obtained from the NCI Cancer Therapy Evaluation Program. Entries were analyzed by patient age, gender, race, type of cancer treated, and calendar year of trial entry. Results: Overall, national cancer treatment trial entries declined after 9–11–2001 and in 2003 reached the lowest levels since 1997. As of 2005 accrual recovered to pre 9–11 levels only in 15–29 and >60 year-olds, with the former demonstrating the greatest gain ( Table ). Entries among <15 and 30–49 year- olds declined steadily since 1997 with no evidence for recovery as of 2005 ( Table ). Overall, the estimated proportion of the nation's cancer patients entered onto national treatment trials remains below 3%. Conclusions: Despite continued national and local efforts to increase the participation of cancer patients on clinical trials, accompanied by significant increases in the NIH and NCI budgets, there is little evidence of a beneficial impact. The effect of 9–11 has yet to be overcome, except in young and elderly adults, in whom specific, targeted initiatives appear to have been successful. The latter approaches may be useful to apply to other age groups, particularly in view of the recent cuts in the cooperative group budgets and current mandated decreases in study accruals. No significant financial relationships to disclose. [Table: see text]

Download Full-text

Factors Affecting Workload of Cancer Clinical Trials: Results of a Multicenter Study of the National Cancer Institute of Canada Clinical Trials Group

Journal of Clinical Oncology ◽

10.1200/jco.2002.20.2.545 ◽

2002 ◽

Vol 20 (2) ◽

pp. 545-556 ◽

Cited By ~ 34

Author(s):

Kathyrn Roche ◽

Nancy Paul ◽

Bobbi Smuck ◽

Marlo Whitehead ◽

Benny Zee ◽

...

Keyword(s):

Clinical Trials ◽

Data Collection ◽

Cancer Treatment ◽

Multicenter Study ◽

National Cancer Institute ◽

Phase Iii ◽

Study Phase ◽

Factors Affecting ◽

Clinical Research Associates

PURPOSE: Increasingly, cancer treatment centers need to be able to estimate specific costs and resources associated with clinical trials. Because the time requirements of trial coordination and data collection are not well known, the Clinical Research Associates (CRA) Committee of the National Cancer Institute of Canada Clinical Trials Group carried out a multicenter study to measure trials’ task times and evaluate the effects of certain factors. METHODS: A data collection instrument was designed and validated before its implementation in the study. Eighty-three CRAs from 24 cancer treatment institutions across Canada collected timing observations of 41 tasks (156 subtasks). Information from all stages of trials activity (protocol management, eligibility and entry, treatment, and follow-up and final stage) was obtained, from initial negotiations to follow-up after study closure. RESULTS: After controlling for stage, phase and sponsor were found to be significant independent factors. Analysis within the stages showed similar patterns. New drug inclusion as a factor was confounded with phase. Industry-sponsored studies had significantly higher overall mean times than did local and cooperative group studies. Early-phase studies required more time than did phase III trials. External sponsorship of any kind increased CRA time more than that necessary for locally coordinated studies, except during the protocol management stage. The burden of a phase I study increased to greater than average once underway and accruing patients. CONCLUSION: Our data demonstrated that sponsor and study phase are important factors to be taken into consideration when estimating clinical trial costs and resource use.

Download Full-text

Fatigue in patients with cancer: results with National Cancer Institute of Canada Clinical Trials Group studies employing the EORTC QLQ-C30

Supportive Care in Cancer ◽

10.1007/s005200050100 ◽

1997 ◽

Vol 5 (5) ◽

pp. 410-413 ◽

Cited By ~ 51

Author(s):

J. L. Pater ◽

Benny Zee ◽

Michael Palmer ◽

Dianne Johnston ◽

David Osoba

Keyword(s):

Clinical Trials ◽

National Cancer Institute ◽

Patients With Cancer ◽

Eortc Qlq C30 ◽

Eortc Qlq

Download Full-text

Extracting genetic alteration information for personalized cancer therapy from ClinicalTrials.gov

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocw009 ◽

2016 ◽

Vol 23 (4) ◽

pp. 750-757 ◽

Cited By ~ 10

Author(s):

Jun Xu ◽

Hee-Jin Lee ◽

Jia Zeng ◽

Yonghui Wu ◽

Yaoyun Zhang ◽

...

Keyword(s):

Clinical Trials ◽

Cancer Therapy ◽

Cancer Treatment ◽

Knowledge Base ◽

Genetic Alterations ◽

Genetic Alteration ◽

Treatment Trials ◽

Personalized Cancer Therapy ◽

Personalized Cancer ◽

Manual Review

Abstract Objective: Clinical trials investigating drugs that target specific genetic alterations in tumors are important for promoting personalized cancer therapy. The goal of this project is to create a knowledge base of cancer treatment trials with annotations about genetic alterations from ClinicalTrials.gov. Methods: We developed a semi-automatic framework that combines advanced text-processing techniques with manual review to curate genetic alteration information in cancer trials. The framework consists of a document classification system to identify cancer treatment trials from ClinicalTrials.gov and an information extraction system to extract gene and alteration pairs from the Title and Eligibility Criteria sections of clinical trials. By applying the framework to trials at ClinicalTrials.gov, we created a knowledge base of cancer treatment trials with genetic alteration annotations. We then evaluated each component of the framework against manually reviewed sets of clinical trials and generated descriptive statistics of the knowledge base. Results and Discussion: The automated cancer treatment trial identification system achieved a high precision of 0.9944. Together with the manual review process, it identified 20 193 cancer treatment trials from ClinicalTrials.gov. The automated gene-alteration extraction system achieved a precision of 0.8300 and a recall of 0.6803. After validation by manual review, we generated a knowledge base of 2024 cancer trials that are labeled with specific genetic alteration information. Analysis of the knowledge base revealed the trend of increased use of targeted therapy for cancer, as well as top frequent gene-alteration pairs of interest. We expect this knowledge base to be a valuable resource for physicians and patients who are seeking information about personalized cancer therapy.

Download Full-text

Analysis of Maryland Cancer Patient Participation in National Cancer Institute–Supported Cancer Treatment Clinical Trials

Journal of Health Care for the Poor and Underserved ◽

10.1353/hpu.0.0162 ◽

2009 ◽

Vol 20 (2A) ◽

pp. 120-134 ◽

Cited By ~ 10

Author(s):

Claudia R. Baquet ◽

Gary L. Ellison ◽

Shiraz I. Mishra

Keyword(s):

Clinical Trials ◽

Cancer Patient ◽

Cancer Treatment ◽

Patient Participation ◽

National Cancer Institute

Download Full-text

Reporting of health‐related quality of life endpoints in National Cancer Institute–supported cancer treatment trials

Cancer ◽

10.1002/cncr.32765 ◽

2020 ◽

Vol 126 (11) ◽

pp. 2687-2693 ◽

Cited By ~ 3

Author(s):

Diane St Germain ◽

Andrea Denicoff ◽

Andrea Torres ◽

Joseph Kelaghan ◽

Worta McCaskill‐Stevens ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Treatment ◽

National Cancer Institute ◽

Health Related Quality ◽

Treatment Trials ◽

Related Quality ◽

Health Related

Download Full-text

P09 Database management of national cancer institute-sponsored cancer treatment trials

Controlled Clinical Trials ◽

10.1016/0197-2456(93)90141-y ◽

1993 ◽

Vol 14 (5) ◽

pp. 430

Author(s):

Pamela H. Phillips ◽

Donald A. Vena ◽

Christine L. Carter ◽

Bruce D. Cheson

Keyword(s):

Cancer Treatment ◽

National Cancer Institute ◽

Database Management ◽

Treatment Trials

Download Full-text

Treatment profiles in patients with cancer aged 80 years or more

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.19620 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 19620-19620

Author(s):

A. M. Noonan ◽

A. M. Horgan ◽

L. Grogan ◽

O. S. Breathnach

Keyword(s):

Clinical Trials ◽

Cancer Treatment ◽

Cancer Diagnosis ◽

Treatment Plan ◽

Performance Status ◽

Poor Performance ◽

Poor Performance Status ◽

Very Elderly ◽

Patients With Cancer ◽

Oncology Clinical Trials

19620 Background: There is much criticism about the omission of very elderly patients (>80 years old) from clinical trials. The question is raised as to whether results of clinical trials performed with younger pts (usually <75 years) can be extrapolated to the very elderly population. The most recent Irish census predicts that those aged =80 yrs is set to rise dramatically from the 2001 level of 98,000 to a projected 323,000 in 2036. Accordingly oncologists will have to plan carefully to appropriately treat these pts. Methods: A retrospective review of all new pts referrals aged =80 years was performed for the period Sept. 2005 to Sept. 2006. Pts records were analysed for age, cancer diagnosis, co-morbidities, treatment plan and complications. Results: A total of 52 referrals were identified but records were available for only 49 pts. The average age was 83.7 years (80–93yrs). The M:F ratio was 1.04:1. The 4 most common cancers were Colorectal (20%), lung (18%), oesophageal (12%) and breast (10%). The mean number of co-morbidities was 5. 13 pts (26%) had a previous unrelated cancer diagnosis. 19 patients (38.8%) received cancer treatment (see table ). Three other pts were offered chemotherapy but declined citing age and fear of side effects as their reasons. 68% of patients receiving cancer treatment had a performance status (PS) of ECOG =1. The main reasons cited for not giving cancer treatment were poor PS (21), comorbidities (13), or patient preference (3). 75% of patients receiving chemotherapy were on schedule with no delays. Only 25% (2) of patients experienced delays due to toxicity. Conclusion: In this diverse group of very elderly cancer pts, those that received cancer treatment tolerated it reasonably well. However, 55% of pts were deemed unfit for cancer treatment at presentation due to poor performance status or compromising co-morbidities. This fact must be taken into account when setting recruitment targets for this age group when planning oncology clinical trials. No significant financial relationships to disclose. [Table: see text]

Download Full-text