;The responsibility for data and safety monitoring in the Case CCC rests with the Data Safety and Toxicity Committee (DSTC). The DSTC resides within the Case CCC Clinical Research Office (CRO), which oversees and coordinates the activities of the Clinical Trials Core Facility (CTCF), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring, and Protocol Specific Research Support. The charge of the DSTC is to oversee all aspects of data and safety monitoring for institutionally sponsored trials, investigator-initiated trials and, in particular, those trials that do not have external monitoring, such as those supported by NCI through ROI, R21, P01, and U01 mechanisms;and to provide oversight for patient safety for all other trials (i.e., industry-sponsored). The DSTC membership includes diverse expertise from consortium institutions including: medical oncology, radiation oncology, surgical oncology, biostatistics, pharmacy, nursing and quality assurance. In accordance with the Case CCC Data and Safety Monitoring Plan (approved by NCI in December 2011), the DSTC is responsible for reviewing the following: 1) all internal serious adverse events (SAEs);2) externally submitted IND action letters;3) IRB continuing reviews including review of toxicity;4) internal and external audit reports;5) confirmation of objective responses reported in investigator-initiated studies;and 6) early stopping rule milestones as appropriate for the degree of risk in the particular clinical trial. The DSTC is an independent committee that has the authority to immediately suspend a trial for safety considerations. The DSTC communicates its actions to the Pl, IRB, PRMC, and to the Case CCC Associate Director for Clinical Research.
;The Case Comprehensive Cancer Center is Northeast Ohio's only NCI designated comprehensive cancer center providing bench-to-bedside medical research involving partnerships between basic, clinical and population scientists to speed translation of laboratory discoveries into new prevention/intervention and cancer treatments.
|Levinson, Kimberly L; Jernigan, Amelia M; Flocke, Susan A et al. (2016) Intimate Partner Violence and Barriers to Cervical Cancer Screening: A Gynecologic Oncology Fellow Research Network Study. J Low Genit Tract Dis 20:47-51|
|Cooper, Gregory S; Kou, Tzuyung D; Schluchter, Mark D et al. (2016) Changes in Receipt of Cancer Screening in Medicare Beneficiaries Following the Affordable Care Act. J Natl Cancer Inst 108:|
|Wiechert, Andrew; Saygin, Caner; Thiagarajan, Praveena S et al. (2016) Cisplatin induces stemness in ovarian cancer. Oncotarget 7:30511-22|
|Somasegar, Sahana; Li, Li; Thompson, Cheryl L (2016) No association of reproductive risk factors with breast cancer tumor grade. Eur J Cancer Prev :|
|Kenyon, Jonathan; Nickel-Meester, Gabrielle; Qing, Yulan et al. (2016) Epigenetic Loss of MLH1 Expression in Normal Human Hematopoietic Stem Cell Clones is Defined by the Promoter CpG Methylation Pattern Observed by High-Throughput Methylation Specific Sequencing. Int J Stem Cell Res Ther 3:|
|Dowlati, A; Lipka, M B; McColl, K et al. (2016) Clinical correlation of extensive-stage small-cell lung cancer genomics. Ann Oncol 27:642-7|
|Markowitz, Sanford D; Nock, Nora L; Schmit, Stephanie L et al. (2016) A Germline Variant on Chromosome 4q31.1 Associates with Susceptibility to Developing Colon Cancer Metastasis. PLoS One 11:e0146435|
|Wang, Y; Deng, O; Feng, Z et al. (2016) RNF126 promotes homologous recombination via regulation of E2F1-mediated BRCA1 expression. Oncogene 35:1363-72|
|Doherty, Mary R; Smigiel, Jacob M; Junk, Damian J et al. (2016) Cancer Stem Cell Plasticity Drives Therapeutic Resistance. Cancers (Basel) 8:|
|Blum, Andrew E; Venkitachalam, Srividya; Guo, Yan et al. (2016) RNA Sequencing Identifies Transcriptionally Viable Gene Fusions in Esophageal Adenocarcinomas. Cancer Res 76:5628-5633|
Showing the most recent 10 out of 1148 publications