Evolution and landscape of clinical trials for breast cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1601-1601
Author(s):  
Semih Dogan ◽  
Aicha Goubar ◽  
Monica Arnedos ◽  
Suzette Delaloge ◽  
Fabrice Andre
Keyword(s):  
Social Sciences ◽  
Breast Cancer ◽  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Research ◽  
Breast Cancer Research ◽  
Targeted Agents ◽  
First Semester ◽  
Therapeutic Trials ◽  
Number Of Patients

1601 Background: Recent advances in cancer research are expected to have dramatically changed the way clinical trials are being done. In an effort to outline new trends of clinical research in the breast cancer area, we have evaluated the evolution of clinical trials started between 2006 and 2011. Methods: 622 clinical trials, started during the first semester 2006, the second semester 2008 and the first semester 2011, were analyzed. The data source was Clinicaltrials.gov. 30 items were included in the database. Results: The overall number of patients included in prospective clinical trials increased over these periods (n=67,820, n=91,429, n=98,417). However, when large epidemiological cohorts are excluded, a significant fall in the number of patients is seen (n=67,820, n=44,554, n=37,417). The absolute number of therapeutic trials also decreased during this time (n=93, n=99, n=78), mainly related to the dramatic fall in the number of trials testing conventional treatments (n=40, n=24, n=20). In the meantime, the number of trials testing targeted agents remained similar (n=46, n=67, n=50). Interestingly, in the same time, the number of trials testing a targeted agent in a population defined by a biomarker increased (n=1, n=6, n=14). At the opposite, prospective studies aimed at validating biomarkers did not increase, and remained only driven by large consortiums. As illustration, when we exclude RxPONDER trial, the biomarker-validation studies opened in 2011 planned to include only 2 493 patients, representing 2% of the breast cancer research field. Prospective trials testing social sciences and supportive care (n= 70, n=72, n=70) tend to become as important as therapeutic trials. Finally, large epidemiological cohorts opened in 2011 will represent more than 60% of the patients included in clinical trials. Conclusions: The part of cohorts and social sciences in breast cancer research is increasing and represents now the majority of the clinical research activity. When the analysis focuses on therapeutic trials, the breast cancer field recently shifted to targeted agents and early data suggest that therapeutic research is increasingly incorporating companion biomarker. Analysis on all 2,762 clinical trials done between 2006 and 2011 will be presented.

A national survey on patients’ enrollment rate in oncology clinical trials: The French experience.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17567-e17567
Author(s):  
Iris Pauporte ◽  
Valerie Thibaudeau ◽  
Fabien M. Calvo ◽  
Agnes Buzyn
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Public Investment ◽  
University Hospitals ◽  
Public Intervention ◽  
Therapeutic Trials ◽  
Research Activities ◽  
Number Of Patients ◽  
Oncology Clinical Trials ◽  
The Impact

e17567 Background: The rate of patients enrolled in clinical trials (CT) is one of the main indicators of clinical research and care activity. The successive French Cancer Plans (2003-2007 and 2009-2013) aimed at quantifiable targets of patients to be enrolled in high-quality clinical trials. To help investigators achieving this objective, a substantial financial support for clinical research associates (CRA) recruitment was given to University Hospitals (UH), Comprehensive Cancer Centers (CCC) and public or private community hospitals (CH). In the meantime, significant public investment was allocated to competitively selected academic projects through the Clinical Research National Program. Methods: From 2006 to 2011, we carried out annual national surveys on clinical research activities in oncology in France. A questionnaire was sent to cancer care institutions. Number of CT open for enrolment, number of CT sponsored by the institution, number of patients enrolled and human resources (CRA) were collected. Academic and industry-sponsored trials were analyzed separately. Results: We showed that the number of patients enrolled in CT increased continuously over this period: from 21,500 in 2002 to 35,400 in 2011 (+47%). Based on these figures and assuming that there were 420,000 to 472,000 patients eligible for CT over this period, the enrolment rate for patients in CT is estimated to be 7.5 to 8.5% in 2011 versus 5.8 to 6.7% in 2003. Nearly 80% of all enrolled patients were recruited in academic CT; over 75% of patients in therapeutic trials. UH and CCC equally contributed for 80% of enrolment, CH for the residual 20%. At last, the number of CT increased by more than 35% over the same period, while the number of CRA was multiplied by 3 over the French territory. Conclusions: Our results show that public intervention for improving enrolment to cancer CT seems to be efficient. Other types of intervention are being considered, i.e., targeted on investigators, on patients, or on both. Future work should also consider the impact of CT enrolment on patients’ outcome.

Global Breast Cancer Research: Moving Forward

2018 ◽  
pp. 441-450 ◽  
Author(s):  
Carlos H. Barrios ◽  
Tomás Reinert ◽  
Gustavo Werutsky
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Cancer Research ◽  
Clinical Trials ◽  
Access To Health Care ◽  
Breast Cancer Research ◽  
Essential Medicines ◽  
World Health ◽  
Care Needs ◽  
The World

Breast cancer is a major global health problem and major cause of mortality. Although mortality trends are declining in high-income countries, trends are increasing in low- and middle-income countries (LMICs). Addressing global breast cancer research is a challenging endeavor, as notable disparities and extremely heterogeneous realities exist in different regions across the world. Basic global cancer health care needs have been addressed by the World Health Organization’s (WHO) proposed list of essential medicines and by resource-stratified guidelines for screening and treatment. However, specific strategies are needed to address disparities in access to health care, particularly access to new therapies. Discussions about global research in breast cancer should take into account the ongoing globalization of clinical trials. Collaboration fostered by well-established research organizations in North America and Europe is essential for the development of infrastructure and human resources in LMICs so that researchers in these countries can begin to address regional questions. Specific challenges that impact the future of global breast cancer research include increasing the availability of trials in LMICs, developing strategies to increase patient participation in clinical trials, and creation of clear guidelines for the development of real-world evidence-based research. The main objective of this review is to encourage the discussion of challenges in global breast cancer research with the hope that collectively we will be able to generate workable proposals to advance the field.

scholarly journals Japan Breast Cancer Research Group (JBCRG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 332-339
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Clinical Trials ◽  
Research Group ◽  
Systemic Chemotherapy ◽  
Operable Breast Cancer ◽  
Breast Cancer Research ◽  
List Type ◽  
Primary Systemic Chemotherapy ◽  
Current Contact

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by Japan Breast Cancer Research Group (JBCRG). Clinical trials include: Study of CEF-DOC as primary systemic chemotherapy for operable breast cancer.Study of FEC-DOC100 as primary systemic chemotherapy for operable breast cancer.DOC-FEC as primary systemic chemotherapy.

Challenges and Threats

2019 ◽  
pp. 283-286
Author(s):  
Evandro de Azambuja ◽  
Fatima Cardoso ◽  
Gilberto Schwartsmann ◽  
Didier Verhoeven ◽  
Wim Demey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Research ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Pharmaceutical Industry ◽  
Breast Cancer Research

Abstract: Breast cancer research requires collaboration between many stakeholders: scientists, the pharmaceutical industry, and patients. The design of trials must be done more in accordance with patients’ needs. More relevant endpoints must be selected. The gap between innovation and clinical practice must be closed. Power and fashion limit optimal achievement of clinical trials.

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