Building an Information System for Collaborative Researchers: A Case Study from the Brain-tumor Research Domain

Author(s):  
SANDRA A. MAMRAK ◽  
JOHN BOYD ◽  
IVÁN ORDÓÑEZ
1997 ◽  
Vol 14 (2) ◽  
pp. 131-137 ◽  
Author(s):  
Sandra A. Mamrak ◽  
Allan J. Yates

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2003-2003
Author(s):  
Stuart A. Grossman ◽  
Louis B. Nabors ◽  
Joy D. Fisher ◽  
Patrick Y. Wen ◽  
William C. Timmer ◽  
...  

2003 Background: : In the early 1990’s, the NCI suspended activities of the Brain Tumor Study Group seeking to shift clinical brain tumor research from phase III trials to innovative and correlative rich phase I/II studies. In 1994, NCI funded three early phase brain tumor consortia, later reduced to two consortia in 1999 and one in 2009. In 2020, the NCI announced it would discontinue funding the brain tumor consortium and emphasize pre-clinical glioblastoma drug development (RFA-CA-20-047). Methods: The activities of the New Approaches to Brain Tumor Therapy (NABTT: 1994-2009) and Adult Brain Tumor Consortium (ABTC: 2009-2021) were summarized using data from the Central Operations Office that served the consortia for 27 years. Results: From 1994-2020, 48 consortium meetings were held to discuss, develop, conduct, and evaluate early phase clinical trials. These involved multidisciplinary brain tumor experts (neuro-oncologists, neurosurgeons, radiation oncologists, neuropathologists, statisticians, pharmacologists, imaging experts, immunologists, etc) from 27 US academic centers and hospitals. 85 clinical trials were written, approved by NCI and the Brain Malignancy Steering Committee, and conducted. Most trials evaluated NCI-provided therapeutic agents. 34 trials were conducted in collaboration with 27 pharmaceutical companies eager to develop malignant brain tumor therapeutics; for 9 of these the consortia held the IND. 4870 patients were accrued: 3375 to therapeutic and 1495 to non-therapeutic studies. 49 grant proposals were submitted to fund consortium activities with a 46% approval rate. 91 peer reviewed manuscripts were published, with 174 presentations and abstracts. 18 pharmaceutical symposia were conducted to attract new agents toward early phase brain tumor research. Consortia sponsored 34 Guest Lectureships and multidisciplinary symposia to focus on relevant critical research areas. Additionally, the consortia provided unique opportunities for young faculty to lead multicenter NABTT/ABTC trials with appropriate support and mentorship. Conclusions: Therapeutic progress for high grade gliomas has been slow for many reasons (95% of systemically administered agents do not penetrate the blood-brain barrier, inherent treatment resistance, immunologically “cold” phenotype, etc). NABTT/ABTC focused multidisciplinary, multi-institutional experts on major challenges unique to brain tumor research. The consortia developed innovative early phase clinical studies rich in correlative endpoints, fostered research grants, hosted relevant topical symposia, and provided leadership roles for young investigators while bringing together the NCI, industry, and committed multidisciplinary academicians to explore novel therapeutic options for patients with primary brain tumors.


2014 ◽  
Vol 16 (suppl 5) ◽  
pp. v98-v98
Author(s):  
B. Frentzen, ◽  
D. Mitchell, ◽  
W. A. Friedman ◽  
A. Yachnis ◽  
R. McTiernan

2019 ◽  
Vol 1 (Supplement_2) ◽  
pp. ii42-ii42
Author(s):  
Keiko Furukawa ◽  
Yoshiki Arakawa ◽  
Yohei Mineharu ◽  
Masahiro Tanji ◽  
Akifumi Takaori ◽  
...  

Abstract BACKGROUND Clinical physicians have difficulties in conducting investigator-initiated-trials because of increasing clinical duties in Japan. Therefore, physician support can be one of the important factors for quality control and quality assurance. In Kyoto University Hospital, clinical research professional’s support for physician had started at November 2012. In this study, we evaluate effect of physician supports on quality control and quality assurance in clinical brain tumor research. METHODS Our department of Neurosurgery has been a member of Brain Tumor Study Group in Japan Clinical Oncology Group (JCOG) since 2007. The number of registered patients, the status of periodic monitoring, the occurrence of inquiries per case, and details of physicians’ support (items, frequency, methods, etc.) in each clinical trial were investigated. The factors affecting the audit results conducted by JCOG Audit Committee on January 2013 and February 2019 are examined. RESULTS There are seven trials have been ongoing on or started since November 2012. There are fifty patients registered in the clinical studies until July 2019. Periodic monitoring has been carried out in 214 patients of cumulative total number since 2012. Physicians’ support mainly involved the preparation of ethical review documents, CRF documentation, responses to data queries, preparation of SAE reports, study schedule check and monitoring of observation items. The audit results of site visit were acceptable, total evaluation score 68.80 on January 2013 and excellent, total evaluation score 99.9 on February 2019. CONCLUSION Clinical Trials Act has been implemented, and further improvement in the quality of clinical trials has been demanded. As the results of this study, we clarified the necessity for physician support and the contribution to quality improvement.


2017 ◽  
Vol 19 (suppl_6) ◽  
pp. vi175-vi175
Author(s):  
Meijing Wu ◽  
Ting Xiao ◽  
Jason Miska ◽  
J Robert Kane ◽  
Deepak Kanojia ◽  
...  

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