scholarly journals Improving Cancer Outcomes Through International Collaboration in Academic Cancer Treatment Trials

2009 ◽  
Vol 27 (30) ◽  
pp. 5109-5114 ◽  
Author(s):  
Edward L. Trimble ◽  
Jeffrey S. Abrams ◽  
Ralph M. Meyer ◽  
Fabien Calvo ◽  
Eduardo Cazap ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
International Collaboration ◽  
Therapeutic Strategies ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Treatment Trials ◽  
Governmental Organizations ◽  
International Collaborations ◽  
Global Harmonization

Purpose The need for international collaboration in cancer clinical trials has grown stronger as we have made progress both in cancer treatment and screening. We sought to identify those efforts already underway which facilitate such collaboration, as well as barriers to greater collaboration. Methods We reviewed the collective experiences of many cooperative groups, governmental organizations, nongovernmental organizations, and academic investigators in their work to build international collaboration in cancer clinical trials across multiple disease sites. Results More than a decade of work has led to effective global harmonization for many of the elements critical to cancer clinical trials. Many barriers remain, but effective international collaboration in academic cancer treatment trials should become the norm, rather than the exception. Conclusion Our ability to strengthen international collaborations will result in maximization of our resources and patients, permitting us to change practice by establishing more effective therapeutic strategies. Regulatory, logistical, and financial hurdles, however, often hamper the conduct of joint trials. We must work together as a global community to overcome these barriers so that we may continue to improve cancer treatment for patients around the world.

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

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.

The European Organisation for Research and Treatment of Cancer Imaging Programme

2010 ◽  
Vol 06 (01) ◽  
pp. 92
Author(s):  
John Bean ◽  
Jocelyne Flament ◽  
Pascal Ruyskart ◽  
Françoise Meunier ◽  
◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Treatment ◽  
Cancer Imaging ◽  
Therapeutic Strategies ◽  
Cancer Clinical Trials ◽  
Imaging Technologies ◽  
European Organisation

The European Organisation for Research and Treatment of Cancer (EORTC), an international organisation under Belgian law, develops, conducts, co-ordinates and stimulates translational and clinical research in Europe aimed at improving the management of cancer and related problems by increasing survival and also improving patient quality of life. Imaging is now playing an increasingly important role in the treatment of cancer, and in order to further its mission to improve the standard of cancer treatment through the testing of more effective therapeutic strategies, the EORTC has initiated a cancer imaging programme. The objectives of this programme are to build an image exchange platform for cancer clinical trials, create an EORTC Imaging Group, network with stakeholders in cancer imaging, stimulate the integration of imaging components into EORTC studies, participate in major EU initiatives and link up with US co-operative groups. The EORTC is dedicated to improving the quality and consistency of evaluation of cancer treatment within its clinical trials through the incorporation of imaging technologies used for treatment definition for radiotherapy, staging, prediction and evaluation of response, or pathology.

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

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6551-6551 ◽  
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]

Identification of Cancer Care and Protocol Characteristics Associated With Recruitment in Breast Cancer Clinical Trials

2008 ◽  
Vol 26 (27) ◽  
pp. 4458-4465 ◽  
Author(s):  
Julie Lemieux ◽  
Pamela J. Goodwin ◽  
Kathleen I. Pritchard ◽  
Karen A. Gelmon ◽  
Louise J. Bordeleau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Care ◽  
Primary Objective ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Number Of Patients ◽  
Trial Protocols ◽  
Few Data

Purpose It is estimated that only 5% of patients with cancer participate in a clinical trial. Barriers to participation may relate to available protocols, physicians, and patients, but few data exist on barriers related to cancer care environments and protocol characteristics. Methods The primary objective was to identify characteristics of cancer care environments and clinical trial protocols associated with a low recruitment into breast cancer clinical trials. Secondary objectives were to determine yearly recruitment fraction onto clinical trials from 1997 to 2002 in Ontario, Canada, and to compare recruitment fraction among years. Questionnaires were sent to hospitals requesting characteristics of cancer care environments and to cooperative groups/pharmaceutical companies for information on protocols and the number of patients recruited per hospital/year. Poisson regression was used to estimate the recruitment fraction. Results Questionnaire completion rate varied between 69% and 100%. Recruitment fraction varied between 5.4% and 8.5% according to year. More than 30% of patients were diagnosed in hospitals with no available trials. In multivariate analysis, the following characteristics were associated with recruitment: use of placebo versus not (relative risk [RR] = 0.80; P = .05), nonmetastatic versus metastatic trial (RR = 2.80; P < .01), and for nonmetastatic trials, protocol allowing an interval of 12 weeks or longer versus less than 12 weeks (from diagnosis, surgery, or end of therapy) before enrollment (RR = 1.36; P < .01). Conclusion Allowable interval of 12 weeks or longer to randomly assign patients in clinical trials could help recruitment. In our study, absence of an available clinical trial represented the largest barrier to recruitment.

The Coalition of cancer cooperative groups GI scientific leadership council

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13522-13522
Author(s):  
R. B. Catalano ◽  
R. L. Comis ◽  
M. J. O’Connell
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Pharmaceutical Industry ◽  
Research Priorities ◽  
Science Research ◽  
The United States ◽  
Advisory Group ◽  
Cancer Clinical Trials ◽  
Cooperative Groups ◽  
Patient Advocate

13522 Background: The Coalition of Cancer Cooperative Groups convened the GI Scientific Leadership Council (GI SLC) to provide leadership in establishing and advancing national research priorities for colorectal cancer clinical trials. A key objective was to complement and enhance the scientific programs of the NCI-sponsored GI Intergroup. Methods: A multidisciplinary group of investigators representing the spectrum of diagnostic, therapeutic, and laboratory disciplines engaged in colorectal cancer clinical research was convened in December 2004 to address the most important research opportunities in colorectal cancer, and clinical trials to address those opportunities. In April 2005, the concepts evolved were discussed with representatives of the patient advocate community and the pharmaceutical industry. In December 2005 the GI SLC presented its core research recommendations to more than 100 members of the cancer community. Results: Seven principal cross-cutting themes emerged, as well as ten strategic recommendations to be addressed over the next three years. A portfolio of high priority clinical trials was identified. The GI SLC has prioritized support for three colon cancer surgical adjuvant trials; two rectal cancer surgical adjuvant trials; two colorectal cancer metastatic to the liver trials; two metastatic colorectal trials; and one colon polyp and cancer detection study trial. These will be detailed in our presentation. Conclusions:The GI Scientific Leadership Council represents a novel approach to strengthen colorectal cancer clinical trials and correlative science research in the United States by providing a platform to bring together clinical investigators and translational researchers, the patient advocate community, and the pharmaceutical industry. The GI SLC plans to convene a Cancer Prevention Advisory Group in the first quarter of 2006 and plans to initiate one or more innovative clinical trials in collaboration with industry in 2006. The GI SLC will meet throughout 2006 to develop action plans, review progress towards those plans, and facilitate adoption of the research priorities across the cancer community. No significant financial relationships to disclose.

scholarly journals Issues and Challenges With Integrating Patient-Reported Outcomes in Clinical Trials Supported by the National Cancer Institute–Sponsored Clinical Trials Networks

2007 ◽  
Vol 25 (32) ◽  
pp. 5051-5057 ◽  
Author(s):  
Deborah Watkins Bruner ◽  
Charlene J. Bryan ◽  
Neil Aaronson ◽  
C. Craig Blackmore ◽  
Michael Brundage ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Cancer Control ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Cooperative Groups ◽  
End Points ◽  
Patient Reported

Purpose The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups. Methods An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group. Results There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives. Conclusion The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.

Increasing Minority Participation in Cancer Clinical Trials: The Minority-Based Community Clinical Oncology Program Experience

2005 ◽  
Vol 23 (22) ◽  
pp. 5247-5254 ◽  
Author(s):  
Worta McCaskill-Stevens ◽  
Martha M. McKinney ◽  
Cynthia G. Whitman ◽  
Lori M. Minasian
Keyword(s):  
Clinical Trials ◽  
Temporal Trends ◽  
Cancer Clinical Trials ◽  
Cooperative Group ◽  
Factors Affecting ◽  
Treatment Trials ◽  
Minority Participation ◽  
Minority Enrollment ◽  
Community Clinical Oncology Program ◽  
Major Factors

Purpose The National Cancer Institute's (NCI) Minority-Based Community Clinical Oncology Program (MBCCOP) seeks to enhance minority participation in cancer clinical trials by building clinical trials outreach and management capacity in healthcare institutions serving large numbers of minority cancer patients. This article examines temporal trends in MBCCOP accruals to cancer prevention and control (CP/C) and cancer treatment trials and the racial distribution of study participants, along with the major factors affecting minority enrollment. Methods We used NCI databases to analyze temporal trends in overall accruals and accruals by race. We analyzed transcripts from an NCI-sponsored meeting with MBCCOP principal investigators and data from a follow-up survey to identify factors affecting minority enrollment. Results Between 1992 and 2003, annual patient accruals to treatment trials increased 39% despite little change in the number of MBCCOP grantees. During this same period, annual participant accruals to CP/C trials more than doubled. Between 1995 and 2003, minorities comprised 51% to 67% of the MBCCOP patients accrued to cooperative group treatment trials compared with ≤ 23% of the patients accrued by other cooperative group members and affiliates. Major factors affecting minority enrollment include the availability of “clinically relevant” protocols, regulatory requirements, characteristics of the patient population, and the level of support from sponsoring institutions and community physicians. Conclusion MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials. However, the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

Increasing Clinical Trials Accrual at a Comprehensive Cancer Center

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1266-1266
Author(s):  
Bayard L. Powell ◽  
Debbie Olson ◽  
Robert M. Morrell ◽  
Terry L. Hales ◽  
Kevin P High ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Critical Role ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Point System ◽  
Cancer Clinical Trials ◽  
Treatment Trials ◽  
Academic Year ◽  
Year 2013

Abstract Background: During the academic year 2013 (July 2012-June 2013) our accrual to cancer clinical trials, a critical measure of success for a Comprehensive Cancer Center (CCC), was lower than prior years and below the desired level for CCC core grant renewal. Academic physicians were faced with increasing pressures to meet clinical demands, often at the expense of academic productivity, including clinical research. Methods: Our Dean and clinical leadership committed to support our efforts to increase accrual to clinical trials by providing salary support for our Section on Hematology and Oncology for specific milestones of 5%, 10%, and 15% increases in accrual to all clinical trials and in accrual to treatment (NCI definition) trials. The goal of the faculty was to increase accrual by > 15% to all trials and to treatment trials to maximize the “pool”. To determine how to divide the pool among investigators we developed a point system recognizing clinical investigators for roles as a) PI for trials (with additional points for all accrual to their trials) and b) for entering patients on clinical trials. The point system for both roles (PI and entering patients) was weighted relative to the value of the trial to the CCC, e.g. investigator initiated > cooperative group > industry initiated, and treatment trials >> non-treatment trials. In addition, we awarded points for publications (first and senior author > co-author) and presentations (oral > poster; major national meeting > other meetings). Results: During academic year 2014 (July 2013-June 2014) accrual to all cancer clinical trials increased by 140% (276 to 663) and accrual to treatment trials increased 40% (114 to 160). These increases occurred in both hematologic malignancies (95% all; 16% treatment) where we had a strong track record for accruals, and in solid tumors (200% all; 76% treatment) where our prior record was not as strong. Discussion: Accrual to clinical trials, both treatment and non-treatment improved dramatically. Interpretation of cause and effect is complex. The baseline year (2013) included implementation of a new EMR and the recent year (2014) included recruitment of additional faculty. However, 2014 was complicated by implementation of a new practice plan heavily weighted toward individual RVU production, and a decrease in available co-operative group trials to historically low levels. However, we can conclude that attention to this critical role of clinical investigators is important and can influence behavior. We cannot determine whether financial incentives are needed or whether the funding is one of several potential methods of recognition of the importance of clinical trials. It is possible that the commitment to provide financial support for clinical research demonstrated to clinical investigators that the leadership valued clinical trials activity and this recognition was more important than the actual funds. Future efforts will also need to find ways to recognize/reward clinical trials productivity of groups of investigators for their multidisciplinary contributions to the care of patients on clinical trials, without generating internal competition within the groups. Disclosures No relevant conflicts of interest to declare.

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

2016 ◽  
Vol 23 (4) ◽  
pp. 750-757 ◽  
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.

Sign in / Sign up

Export Citation Format

Share Document